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Статті в журналах з теми "Finished Pharmaceutical Product"

Автор: Grafiati

Опубліковано: 3 червня 2025

Оновлено: 31 липня 2025

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1

Chandel, Vikas, Hemendra Pratap Singh, Nilesh Rarokar, and Kamlesh Wadher. "Stabilization of the pharmaceutical finished dosages form by using various techniques." Journal of Drug Delivery and Therapeutics 14, no. 6 (2024): 44–50. http://dx.doi.org/10.22270/jddt.v14i6.6619.

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The stabilization of pharmaceuticals means that the drug product is physically, chemically and microbiologically stable at the recommended storage condition throughout the predefined shelf life of the product. Pharmaceutical formulations irrespective of its physical states have been used for their efficacy and safety so for as its therapeutic activity is concern. Stability of dosage forms is the ability of drugs to remains unaffected by environmental condition viz. temperature, humidity and microbiological contamination. This research work is an attempt to stabilize the drug product at control

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2

Ishita Sharma, Kumud Upadhyay, and Sushil Giri. "Prioritizing metal detector for finished pharmaceutical formulation: Manufacturing safe, quality product." World Journal of Advanced Research and Reviews 16, no. 3 (2022): 482–89. http://dx.doi.org/10.30574/wjarr.2022.16.3.1339.

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Background: The pharmaceutical metal detector is a device to detect metal as well as non-metal contaminants of large size in the pharmaceutical dosage form. The detection of unwanted metal (contaminant) is important to produce a high quality of the dosage form. Main body: Pharmaceutical dosage forms are highly sensitive to the environment to which they are surrounded. It is challenging to keep a product in its original form throughout its shelf life. These metals find entry in the pharmaceutical formulation during various phases of manufacturing while passing through pipelines, sieves, conveyo

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3

Rafael, Bence, Nóra Kuruczleki, and József Gál. "The way of the pharmaceutical ingredients to the finished pharmaceutical form." Analecta Technica Szegedinensia 12, no. 2 (2018): 24–31. http://dx.doi.org/10.14232/analecta.2018.2.24-31.

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The modern pharmaceutical industry is a strictly controlled area. Both national and international rules apply, but none of these deals with logistical issues arising from the manufacture of the product. Following the path of a drug, it is possible to get acquainted with the problems that arise and their solution. The drug is much more than a common product. The drug is a product of confidence, which is provided with information. It defines its quality as well, to comply with the relevant directives and standards in the manufacture of, and that the enclosed information is sent to the user

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4

Ishita, Sharma, Upadhyay Kumud, and Giri Sushil. "Prioritizing metal detector for finished pharmaceutical formulation: Manufacturing safe, quality product." World Journal of Advanced Research and Reviews 16, no. 3 (2022): 482–89. https://doi.org/10.5281/zenodo.7902304.

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<strong>Background: </strong>The pharmaceutical metal detector is a device to detect metal as well as non-metal contaminants of large size in the pharmaceutical dosage form. The detection of unwanted metal (contaminant) is important to produce a high quality of the dosage form. <strong>Main body</strong>: Pharmaceutical dosage forms are highly sensitive to the environment to which they are surrounded. It is challenging to keep a product in its original form throughout its shelf life. These metals find entry in the pharmaceutical formulation during various phases of manufacturing while pas

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5

Varsha, Kshirsagar. "IN-PROCESS QUALITY CONTROL: A SYSTEMATIC APPROACH TO CONTROL CRITICAL STEPS IN FINISHED PHARMACEUTICAL PRODUCTS." INDO AMERICAN JOURNAL OF PHARMACEUTICAL RESEARCH 07, no. 01 (2017): 7369–73. https://doi.org/10.5281/zenodo.1006759.

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The main objective of pharmaceutical industry is to manufacture the quality products. Quality cannot be tested in the product it should be built- in by design and verified during the process with careful attention to the extent possible rather than depend alone on the end product testing. Many factors are responsible to give assurance of the quality of product. One of them is In-Process Quality Control Checks (IPQC). Critical points of all stages of the manufacturing process being checked by In-Process Quality Control according to standard operation procedures (SOPs). These applied SOPs vary f

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6

Zmysłowski, Adam, Iza Książek, and Arkadiusz Szterk. "N-Nitrosodimethylamine Contamination in the Metformin Finished Products." Molecules 25, no. 22 (2020): 5304. http://dx.doi.org/10.3390/molecules25225304.

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A GC–MS/MS method with EI ionization was developed and validated to detect and quantify N-nitrosodimethylamine (NDMA) and seven other nitrosamines in 105 samples of metformin tablets from 13 different manufactures. Good linearity for each compound was demonstrated over the calibration range of 0.5–9.5 ng/mL. The assay for all substances was accurate and precise. NDMA was not detected in the acquired active pharmaceutical ingredient (API); however, NDMA was detected in 64 (85.3%) and 22 (91.7%) of the finished product and prolonged finished product samples, respectively. European Medicines Agen

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7

Md., Sahab Uddin, Al Mamun Abdullah, Tanvir Kabir Md., et al. "Quality Control Tests for Ophthalmic Pharmaceuticals: Pharmacopoeial Standards and Specifications." Journal of Advances in Medical and Pharmaceutical Sciences 14, no. 2 (2017): 1–17. https://doi.org/10.9734/JAMPS/2017/33924.

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The therapeutically performance of the pharmaceuticals must be constant and expectable. In order to claim a pharmaceutical to be a quality drug, it must fulfill certain standards and specifications. The quality of pharmaceuticals is strongly related to the patient’s well-being. Quality control (QC) is an historical process in which proof is obtained that the appropriate level of quality has been achieved. QC can have no effect on the quality of the pharmaceuticals. It is merely a measuring process. QC must ensure that all the finished products contain active ingredients that comply with the qu

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8

Smekhova, I. E., L. V. Shigarova, I. A. Narkevich, E. V. Flisyuk, and V. D. Meteleva. "Documentation of Pharmaceutical Development. Part 2. Quality System Documents." Drug development & registration 10, no. 2 (2021): 147–53. http://dx.doi.org/10.33380/2305-2066-2021-10-2-147-153.

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Introduction. In the process of pharmaceutical development of a medicinal product, it is necessary to substantiate the composition of the medicinal product; develop a technology for a finished dosage form (including a primary packaging system); create documentation for various stages of product development; validate analytical methods and technological processes. Information obtained in the course of experimental research and development of a medicinal product is included in the registration dossier. Documenting a pharmaceutical development allows you to systematize knowledge about monitoring

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9

Ghimire, Prakash, Abinash Chandra Shrestha, Sandhya Pandey, Bidur Chapagain, and Samir Dhakal. "Pharmacopoeial comparison of in-process and finished product quality control test for pharmaceutical tablets." GSC Biological and Pharmaceutical Sciences 11, no. 3 (2020): 155–65. https://doi.org/10.5281/zenodo.4271316.

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Анотація:

All Pharmaceutical industries endeavour to produce good quality products which are achieved by allowing in-process and finished product quality control approaches. In-process quality control is concepts that are carried out before, after and during production covering all steps, counting the establishment of specifications, sampling, relevant testing and analytical clearance assuring that the intermediates, packaging materials and finished pharmaceutical tablets conform with approved specifications or standard for efficacy, safety and elegance which assure the consumer that the products perfor

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10

Elmadhoun, Bassam, Rawidh Alsaidalani, and Frank Burczynski. "Quality Risk Management in the Final Operational Stage of Sterile Pharmaceutical Manufacturing: A Case Study Highlighting the Management of Sustainable Related Risks in Product Sterilization, Inspection, Labeling, Packaging, and Storage Processes." Sustainability 17, no. 4 (2025): 1670. https://doi.org/10.3390/su17041670.

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Quality risk management, commonly known as QRM, is designed to systematically assess, control, communicate, and review potential risks at every stage of the pharmaceutical manufacturing process. The preservation of consistent product quality across the entirety of the product’s life cycle is of paramount importance. The aim of this article is to formulate a best practice guide that will assist pharmaceutical manufacturers in comprehending and implementing the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q9: quality risk management pr

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11

Oloninefa, S. D, Aisoni, J. E, Alli, A. I, and Akomolafe, D. O. "A One-Year Environmental and Microbiological Monitoring of Storage Areas and Production Room of a Pharmaceutical Industry from Northern Nigeria." UMYU Journal of Microbiology Research (UJMR) 8, no. 1 (2023): 1–5. http://dx.doi.org/10.47430/ujmr.2381.001.

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The degradation and reduction of the potency of both raw materials and finished pharmaceutical products (FPPs) are of great concern to pharmaceutical industries, making the environmental monitoring of storage areas and production rooms a must. In this study, a one year monthly data for environmental and microbiological monitoring for storage areas (raw materials quarantine room, raw materials approved room, finished product quarantine room and finished product approved room) and production room were collected and analyzed using IBM SPSS Statistics Version 23. The results revealed that the lowe

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12

Mohammad, Abu Sufian Md. Sahab Uddin* Md. Tanjir Islam Tahsin Zahan Kamal Hossain G. M. Sala Uddin Abdullah Al Mamun. "QUALITY CONTROL PARAMETERS OF PARENTERAL PHARMACEUTICALS BASED ON PHARMACOPOEIAS." iajps,csk publications 03, no. 12 (2017): 1624–38. https://doi.org/10.5281/zenodo.260129.

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Анотація:

Quality control is an essential operation of pharmaceutical industries. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation. Currently, world-wide efforts have been made to ensure the practice of quality along with coast effective good quality medicines. Parenterals are the sterile preparation that is directly administered into the circulatory sy

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13

Malik, Anuj, Gourab Gochhayat, Md Shamshir Alam, et al. "Quality by Design: A new practice for production of pharmaceutical products." Journal of Drug Delivery and Therapeutics 9, no. 1-s (2019): 416–24. http://dx.doi.org/10.22270/jddt.v9i1-s.2370.

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Анотація:

This is the advanced approach for development of pharmaceutical product with full range and specified limits of variables during procurements, storage and manufacturing process with a qualification, at desired level of quality within the limits of low and higher values of variables to ensures the Pharmaceutical product Quality by design (QbD) of manufacturing a finished product. The Quality by Design is depicted and a portion of its components recognized and process parameters with quality characteristics are identified for every unit activity. Advantages, openings and steps engaged with Quali

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14

Guk, Olga, and Hanna Mokhonko. "SCRUM METHODOLOGY IN PROJECT MANAGEMENT ON ENTERPRISES IN THE CONDITIONS OF DIGITAL TRANSFORMATION." Economic scope, no. 200 (May 9, 2025): 27–33. https://doi.org/10.30838/ep.200.27-33.

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The article emphasizes the importance of innovative development in the context of project development and implementation to increase enterprises' competitiveness. The significance of pharmaceuticals in countries' economic systems is noted, and the primary statistical data on the industry are considered. The primary project management methods are analyzed. The historical origins of the Scrum methodology are investigated, and its main elements are identified, namely the classification of roles in the team and key concepts. All stages of the Scrum process are considered, from the appearance of an

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15

Richa Shukla, Dr. Nimita Manocha, and Dr. Gurmeet Singh Chhabra. "Theoretical Approaches to Process Validation in Pharmaceutical Manufacturing Process." International Journal of Scientific Research in Science and Technology 11, no. 2 (2024): 573–85. http://dx.doi.org/10.32628/ijsrst52411229.

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Under the more general statutory CGMP provisions of section 501(a)(2)(B) of the Federal Food, Drug and Cosmetic Act, validation of manufacturing processes is deemed a legal part of current good manufacturing practice for active pharmaceutical ingredients (APIs). Validation of manufacturing processes is required by the Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR 211.100 and 211.110). A medication should be created that is suitable for its intended purpose, according to the fundamental tenet of quality assurance. Procedure Validation is the collect

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16

Mahima, Kanojia* Neha Sodiyal Shivanand Patil. "Process Validation in Pharmaceutical Industry." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 5049–56. https://doi.org/10.5281/zenodo.15557939.

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Validation is Essential & key steps towards fulfilling and maintaining  the consistency of the finished  product. If every step of the manufacturing operations is checked and analyzed , we can ensure that obtained end  product is of highest quality and have appropriate effectiveness. Validation is technique  which measures that have been planned alongside the documentation. Validation and quality assurance will jointly  ensure the high quality of items. Process validation / verification  emphasizes process design components and retains procedure management dur

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17

Nylese, T., R. Anderhalt, and V. Gorcea. "Identification of Pharmaceutical Constituents in Finished Product Form Using Low kV Microanalysis." Microscopy and Microanalysis 19, S2 (2013): 272–73. http://dx.doi.org/10.1017/s1431927613003358.

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18

Mishra, Amit Kr, Richa Singh, Deepak Kr Chaurasia, and Dr Tarkeshwar P. Shukla. "A Review: Quality Assurance and Quality Control." International Journal for Research in Applied Science and Engineering Technology 11, no. 1 (2023): 45–47. http://dx.doi.org/10.22214/ijraset.2023.48419.

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Abstract: Quality assurance is part of quality management that ensured the pharmaceutical products are of required quality. It includes GMP, GLP, GCP, product design and development. The finished product is tested & checked according to their procedure. The confidence delivered by quality assurance is twice intrinsically to management and extrinsically to clients, government agencies, regulators, certifiers, and third parties Quality control is a procedure which contemplates on performing the quality demand. Quality control intend to distinguish (and dead-on) imperfection in the finished p

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19

Dr., S. D. Mankar Kalyani Nikam* Vaishnavi Palve Vaishnavi Nirmal Pallavi Palve Jagdish Nikam. "USFDA Guidelines: A review on Pharmaceuticals Formulations." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 1473–79. https://doi.org/10.5281/zenodo.15201903.

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Ensuring Quality in Pharmaceutical Manufacturing should follow ISO9001:2015 Standards and guidelines from regulatory bodies like the FDA, EMA, WHO. To ensure product quality, safety and efficacy which require process validation to guarantee the quality of their products. This applies to both finished drugs and active pharmaceutical ingredients (APIs). The Goal of Quality is the primary objective of Quality Control can produce medications that are secure and essential for their intended use. Process validation involves collecting and analyzing data throughout the manufacturing process, from des

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20

Navya, K., R. Kamaraj, and M. Bharathi. "The Trending Role of Artificial Intelligence and Its Applications in Formulation of Solid Dosage Forms: A Review." ECS Transactions 107, no. 1 (2022): 20049–55. http://dx.doi.org/10.1149/10701.20049ecst.

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Artificial intelligence (A.I) is a technology based system involved in use of advanced tools and software’s and has achieved human level of capabilities and brought a paradigm shift in pharma industry therefore use of A.I in pharmaceutical product development has elevated over past few years. Adopting of technology can save money and time also provide good understanding between formulation and process parameters. Solid dosage forms are predominant in pharmaceutical market. It is estimated that tablets are the most come solid dosage form which contributes more than two-third of global market. T

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21

Manjunath D.N., Shailesh T., and Gowrav M.P. "Annual Product Quality Review." International Journal of Research in Pharmaceutical Sciences 11, no. 2 (2020): 1862–69. http://dx.doi.org/10.26452/ijrps.v11i2.2094.

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Annual Product Quality Review (APQR) is an estimation prepared according to the Current Goods Manufacturing Practice (CGMP) requirements of different regulatory authorities. A Goods Manufacturing Practice (GMP) ensures that the products are constantly produced and controlled according to quality standards. APQR is not only required for GMP but also required for the quality improvement of the pharmaceutical product. APQR is an evaluation carried out annually to measure the standard of quality of each drug with an intention to verify the constancy of current process and to check the correctness

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22

Rahmah, Bella Shefia, and Mundari Siti. "PERANCANGAN ULANG TATA LETAK WAREHOUSE GUNA PERBAIKAN LETAK PRODUK JADI KEMASAN (STUDI KASUS: PT GRAFIKA PRIMA SEJAHTERA)." Jurnal Teknologi dan Manajemen Sistem Industri 2, no. 2 (2023): 98–106. http://dx.doi.org/10.56071/jtmsi.v2i2.610.

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PT. Prima Sejahtera Graphics prints various types of packaging such as pharmaceutical, food and beverage packaging. The problem with today's business finished product storage policies is that each product type is organized according to a predefined pallet area. The empty pallet area creates a wide variety of products in the many types of packages they make. In this case, carriers often return goods based on how they were packaged. The amount of space available at the location of several types of products does not match the output of the final goods. In such a scenario, operators operate ineffi

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23

Ghimire Prakash, Shrestha Abinash Chandra, Pandey Sandhya, Chapagain Bidur, and Dhakal Samir. "Pharmacopoeial comparison of in-process and finished product quality control test for pharmaceutical tablets." GSC Biological and Pharmaceutical Sciences 11, no. 3 (2020): 155–65. http://dx.doi.org/10.30574/gscbps.2020.11.3.0174.

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24

Tarasenko, O. M., A. V. Myhal, V. V. Rudiuk, and O. S. Kukhtenko. "The formulation of the concept of internal transfer as a stage for assessing the process scalability on the example of the scheme for obtaining substance 6-methyluracil." News of Pharmacy 109, no. 1 (2025): 122–28. https://doi.org/10.24959/nphj.25.172.

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Aim. To introduce the concept of internal (laboratory) transfer, in which the transferring party is a pharmaceutical development specialist, and the receiving party is a technology transfer specialist. The study involved determining the main directions of laboratory scaling, searching for visual approaches to its implementation, as well as performing calculations for increased raw material loads using conversion factors. Materials and methods. The study object when determining the transfer algorithm was substance 6-methyluracil, which synthesis was in the conditions of the pharmaceutical enter

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25

Adulapuram Aroon, Akuthota Kavya, Mudhadapu Swetha rani, Mandapati Harshitha, and Nagula Anannya. "Evolution of quality assurance in pharmaceutical industry." World Journal of Biology Pharmacy and Health Sciences 20, no. 2 (2024): 656–61. http://dx.doi.org/10.30574/wjbphs.2024.20.2.0937.

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Анотація:

It is brief review of History of Quality control, Timeline of evolution of quality assurance in pharmacy field, GMP guidelines and current trends. Quality assurance is a term used in systematic process of determining whether a product or service meets specified requirements. Quality assurance also involves establishing and maintaining quality management systems to continually improve processes and prevent defects or deviations. Overall, a Quality assurance plays a critical role in safeguarding public health and maintaining the integrity. The main functions are to provide consumer satisfaction.

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26

Amol, Amrutkar, Aher Smita, and Bachhav Rishikesh. "A Comprehensive Review On Analytical Method Development And Validation." Int. J. in Pharm. Sci. 1, no. 2 (2022): 112–24. https://doi.org/10.5281/zenodo.6260581.

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Анотація:

The top objective of any pharmaceutical industry is to produce products of necessary characteristic and quality reliably, in a cost-effective manner. Development of a method is essential for discovery, development, and evaluation of medicines in the pharmaceutical formulation. The main aim of this review article was to check the development and validation of the procedure employed for the medication from the starting of the formulation to the complete commercial batch of product. At the point when an analytical technique is applied to produce outcomes for the quality of medicine associated sam

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27

Tarapon, K. V., and O. V. Tryhubchak. "Development and validation method for the determination of related substances in nimesulide granules for oral suspension." Current issues in pharmacy and medicine: science and practice 15, no. 3 (2022): 259–65. http://dx.doi.org/10.14739/2409-2932.2022.3.259472.

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One of the key stages of pharmaceutical development is the development of analytical methods for quality control of medicines. The critical quality indicator is the content of related impurities, which may increase during shelf life of the product due to the degradation of the active substance, which in turn affects the quality of the product. The aim of the work is to develop and validate the method for the determination of related impurities in nimesulide granules for oral suspension by HPLC method; to set the specification of finished product for related impurities. Materials and methods. S

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28

Kotrannavar, V. S., R. S. Sarashetty, and V. G. Kanthi. "PHARMACEUTICAL ANALYSIS STUDY OF MAYUR PUCCHA BHASMA." INDIAN DRUGS 49, no. 09 (2012): 23–26. http://dx.doi.org/10.53879/id.49.09.p0023.

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Mayur Puccha Bhasma (calx of peacock feather) is an animal product prepared from Mayur Puccha (peacock feather) and Palash moola (Butea monosperma) kwatha (decoction), Dronapushpi (Leucas cephalotes spreng) swarasa (juice), Chakramarda (cassiatora) swarasa (juice).This preparation is mainly used in the management of Chardhi (vomiting), Hikka (hiccough), Swasa (respiratory disorder). In this study, Mayur Puccha Bhasma was prepared with classical procedure, by giving Gajaputa (by burning at 1000o using 1000 cow dung cakes) to peacock feathers and finished product was subjected to physicochemical

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29

Sokolovska, Zoia. "Simulation Models of Pharmaceutical Logistics." Economics: time realities 4, no. 74 (2024): 99–110. https://doi.org/10.5281/zenodo.13851959.

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The article presents simulation modeling as a mathematical basis for the study of logistic systems. The object is pharmaceutical logistics – logistics chains of pharmaceutical companies. Attention is focused on the problems of functioning of domestic pharmaceutical logistics in the conditions of military realities. The expediency of using simulation modeling technologies to reproduce the changing, force majeure conditions of functioning of the supply channels of finished pharmaceutical products is substantiated. Models of one-level and two-level sales channels for pharmaceutical products

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Gusain, Arvind Singh, Subhash Chandra, Isaac Moura Araújo, João Paulo Martins de Lima, and Henrique Douglas Melo Coutinho. "Scientifically Supported Best Practices in Leachable Screening Studies for Pharmaceutical and Parenteral Drug Products." Future Pharmacology 5, no. 2 (2025): 18. https://doi.org/10.3390/futurepharmacol5020018.

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Анотація:

Purpose: Pharmaceutical parenteral drug products (PDPs) and orally inhaled nasal drug products (OINDPs) are critical medications for patient care, for which the route of administration is intravenous or oral/nasal inhalation, and the drug products directly infuse into the bloodstream or lungs, but they are categorized as high-risk for leachables. Method: These external foreign chemical substances (leachables) may adversely affect and alter patient safety. Results: These primary container closure systems and manufacturing process equipment mainly comprise rubber elastomers, polypropylene, resin

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31

Шевченко, В. О., О. С. Шпичак, and С. М. Ролік-Аттіа. "Risk assessment as an important factor in the process of developing the composition of the injection solution." Farmatsevtychnyi zhurnal, no. 5 (October 27, 2023): 53–61. http://dx.doi.org/10.32352/0367-3057.5.23.06.

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Анотація:

At the stages of pharmaceutical development, production and use of a medicinal product, including its components, there is necessarily a certain degree of risk. An effective approach to quality risk management can further guarantee the patient high quality of the medicinal product by establishing preventive measures to identify and control possible quality issues during pharmaceutical development and production. At the beginning of the pharmaceutical development process, a general risk assessment is performed and it is repeated as information and knowledge deepen, because the medicinal p

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32

Ramesh, Kanteti V. R. N. S., Hemant Yadav, and Omar Sarheed. "Safety of Pharmaceutical Excipients and Regulatory Issues." Applied Clinical Research, Clinical Trials and Regulatory Affairs 6, no. 2 (2019): 86–98. http://dx.doi.org/10.2174/2213476x05666181105123750.

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Background:Pharmaceutical excipients are critical in the formulation of any dosage form. Not many additives employed in the drug product manufacture have properties, which meet the desired qualities that the finished product must have. Therefore, it is mandatory to mix the drug substance with other substances to overcome the deficiencies. As a result, almost all pharmaceutical products are mixtures of active pharmaceutical ingredient and additives. So, there is a compelling need of these substances and normally they occupy the major part of any drug product. Excipients are of different chemica

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Tran Thien Nguyen, Thanh, Vu Anh Nguyen, Huan Quoc Ha, Hiep Khac Long Nguyen, and Diep Thi Thanh Ngo. "Synthesis, establishment of reference standard impurity A of ramipril and assessment of impurities in ramipril products." MedPharmRes 6, no. 4 (2022): 1–10. http://dx.doi.org/10.32895/ump.mpr.6.4.1.

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Introduction: Ramipril, which is an angiotensin-converting enzyme (ACE) inhibitor, is prescribed to treat heart failure, diabetic kidney diseases and high blood pressure. The United States Pharmacopeia 43 (USP 43) and British Pharmacopoeia 2020 (BP 2020) require testing ramipril methyl ester (impurity A) in ramipril pharmaceutical substances as well as corresponding finished products. This study was conducted with the aim of synthesis and standardization of impurity A as related substance and using established reference impurity A in impurity test of ramipril pharmaceutical products. Method: I

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34

Kandle, Hemant S., Sangram S. Patil, Sujata S. Sawant, et al. "STUDIES IN PROSPECTIVE PROCESS VALIDATION OF ALLOPURINOL USP AS ACTIVE PHARMACEUTICAL INGREDIENT." INDIAN DRUGS 58, no. 10 (2021): 42–50. http://dx.doi.org/10.53879/id.58.10.11608.

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Анотація:

Allopurinol USP batches of same size, method, equipment and validation criterion were taken. The critical process parameter involved were reaction, drying, milling, sifting, milling, and blending stages were validation. Quality cannot be assured by daily quality control testing because of the limitations of statistical samples, and the limited facilities of finished product testing. Validation checks the accuracy and reliability of process. Aim of this work was to study prospective process validation of allopurinol USP designed to meet the current regulatory requirements and prove with assuran

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35

Ivanovskiy, Sergey, Ilya Yaichkov, Anton Shetnev, and Mikhail Korsakov. "Development of the chromatographic separation methodology and impurity profiling of 5-(5-trifluoromethyl-isoxazol-3-yl)furan-2-sulfonamide, a drug candidate for the glaucoma treatment." From Chemistry Towards Technology Step-By-Step 4, no. 4 (2023): 138–44. http://dx.doi.org/10.52957/2782-1900-2024-4-4-138-144.

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Glaucoma is the leading cause of irreversible blindness. Early diagnosis and effective treatment can reduce the progression of the disease and prevent irreversible decay of visual functions. Indeed, human carboanhydrase isoform II is a classical target for glaucoma treatment. We proposed a compound molecule 5 (5 trifluoromethyl-isoxazol-3-yl)furan-2-sulfonamide under the project name B016, which showed high activity as a human carboanhydrase II inhibitor by in vitro tests. Our team is currently conducting development and preclinical studies of a medicinal product in the eye drops form based on

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36

Ivanovskiy, Sergey, Ilya Yaichkov, Anton Shetnev, and Mikhail Korsakov. "Development of the chromatographic separation methodology and impurity profiling of 5-(5-trifluoromethyl-isoxazol-3-yl)furan-2-sulfonamide, a drug candidate for the glaucoma treatment." From Chemistry Towards Technology Step-By-Step 4, no. 4 (2023): 60–67. http://dx.doi.org/10.52957/2782-1900-2024-4-4-60-67.

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Анотація:

Glaucoma is the leading cause of irreversible blindness. Early diagnosis and effective treatment can reduce the progression of the disease and prevent irreversible decay of visual functions. Indeed, human carboanhydrase isoform II is a classical target for glaucoma treatment. We proposed a compound molecule 5 (5 trifluoromethyl-isoxazol-3-yl)furan-2-sulfonamide under the project name B016, which showed high activity as a human carboanhydrase II inhibitor by in vitro tests. Our team is currently conducting development and preclinical studies of a medicinal product in the eye drops form based on

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37

Jimenez, Luis. "Molecular Diagnosis of Microbial Contamination in Cosmetic and Pharmaceutical Products: A Review." Journal of AOAC INTERNATIONAL 84, no. 3 (2001): 671–75. http://dx.doi.org/10.1093/jaoac/84.3.671.

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Abstract Molecular methodologies such as adenosine triphosphate (ATP) bioluminescence and polymerase chain reaction (PCR)-based assays provide rapid quality control analysis of cosmetic and pharmaceutical finished products and raw materials. Using a single enrichment broth for bacteria, yeast, and mold, ATP bioluminescence detected microbial contamination within 27 h. Samples were automatically lysed to release microbial ATP and light production was quantitated using the Celsis Optocomp. However, to maintain the detection time to within 27 h, different enrichment broths were required for neutr

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Nikam, Nilam A., Sandhya R.Shinde (Kadam), and Dr Vivek kumar K. Redasani. "In Process and Quality Control Tests for Tablets: A Review." International Journal of Pharmaceutical Research and Applications 10, no. 1 (2025): 1113–20. https://doi.org/10.35629/4494-100111131120.

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Анотація:

All pharmaceutical enterprises aim to create highquality products, which is accomplished by permitting quality control methods for both inprocess and finished products. Assuring that the intermediates, packaging materials, and final pharmaceutical tablets adhere to approved specifications or standards for efficacy, safety, and elegance that reassure the consumer that the products perform consistently and in a manner satisfactory for the purpose for which they are recommended is known as in-process quality control. This concept encompasses all steps that are carried out before, after, and durin

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39

Dronik, M. Yu, I. Jonuškienė, and M. V. Stasevych. "DEVELOPMENT OF THE BASICS OF SPRAY TECHNOLOGY FOR EXTERNAL APPLICATION." Chemistry, Technology and Application of Substances 6, no. 2 (2023): 93–101. http://dx.doi.org/10.23939/ctas2023.02.093.

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Анотація:

The basics of the technology for the preparation of a spray formulation for external use with analgesic and anti-inflammatory effects was developed. The quantitative content of active pharmaceutical ingredients and excipients was proposed. Comparative analysis of some indicators of the obtained spray with analogues on the pharmaceutical market of Ukraine was carried out. Material calculations allowed to estimate the amount of active pharmaceutical ingredients and excipients for the preparation of the spray and its packaging in bottles with a dropper in the laboratory. Based on the material cal

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40

Šimek, Michal, Veronika Grünwaldová, and Bohumil Kratochvíl. "Hot-Stage Microscopy for Determination of API Particles in a Formulated Tablet." BioMed Research International 2014 (2014): 1–6. http://dx.doi.org/10.1155/2014/832452.

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Although methods exist to readily determine the particle size distribution (PSD) of an active pharmaceutical ingredient (API) before its formulation into a final product, the primary challenge is to develop a method to determine the PSD of APIs in a finished tablet. To address the limitations of existing PSD methods, we used hot-stage microscopy to observe tablet disintegration during temperature change and, thus, reveal the API particles in a tablet. Both mechanical and liquid disintegration were evaluated after we had identified optimum milling time for mechanical disintegration and optimum

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41

Moraes de Souza, Carolina, Tayfun Tanir, Marvin Orellana, Aster Escalante, and Michael Sandor Koeris. "Manufacturing Bacteriophages (Part 2 of 2): Formulation, Analytics and Quality Control Considerations." Pharmaceuticals 14, no. 9 (2021): 895. http://dx.doi.org/10.3390/ph14090895.

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Анотація:

Within this second piece of the two-part series of phage manufacturing considerations, we are examining the creation of a drug product from a drug substance in the form of formulation, through to fill-finish. Formulation of a drug product, in the case of bacteriophage products, is often considered only after many choices have been made in the development and manufacture of a drug substance, increasing the final product development timeline and difficulty of achieving necessary performance parameters. As with the preceding review in this sequence, we aim to provide the reader with a framework t

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42

Na-Bangchang, Kesara, Tullayakorn Plengsuriyakarn, and Juntra Karbwang. "Research and Development ofAtractylodes lancea(Thunb) DC. as a Promising Candidate for Cholangiocarcinoma Chemotherapeutics." Evidence-Based Complementary and Alternative Medicine 2017 (2017): 1–16. http://dx.doi.org/10.1155/2017/5929234.

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Treatment and control of cholangiocarcinoma (CCA): the bile duct cancer is limited by the lack of effective chemotherapeutic drugs and alternative drugs are needed, particularly those from natural sources. This article reviews steps of research and development ofAtractylodes lancea(Thunb) DC. (AL) as potential candidate for CCA chemotherapy, with adoption of the reverse pharmacology approach. Major steps include (1) reviewing of existing information on its phytochemistry and pharmacological properties, (2) screening of its activities against CCA, (3) standardization of AL, (4) nonclinical stud

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V. Sravan Kumar, P. Srinivas Babu, B. Gnana Sri Siva Naga Lakshmi, et al. "A Comprehensive Review On Analytical Methods-For The Quantification Of Empagliflozin In Drug Product And Drug Substance." International Journal of Allied Medical Sciences and Clinical Research 12, no. 1 (2024): 57–68. https://doi.org/10.61096/ijamscr.v12.iss1.2024.57-68.

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Pharmaceutical analysis plays an important role in the quantification of drugs in pharmaceutical products and it employs a significant role in the analytical research and development and in quality control of finished products and drug substances and also in the bio analytical method development. Empagliflozin, a new oral anti-diabetic drug which is used to treat the type 2 diabetes and it is a selective sodium- glucose co transport–2[SGLT2] inhibitor by inhibiting the reabsorption of glucose from proximal tubules of the kidney and excretes as such through urine by SGLT-2 receptor inhibition.

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44

Aluri Nandini and Ravi G. "Process validation of sucralfate oral suspension." International Journal of Research in Pharmaceutical Sciences 12, no. 3 (2021): 2005–13. http://dx.doi.org/10.26452/ijrps.v12i3.4808.

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Drugs are the critical elements in the health care system. They must be manufactured in the high-quality levels. End product testing by itself does not guarantee of the quality of the product. Quality assurance techniques must be used. In pharmaceutical industry, process validation performs this task, by ensuring that the process does what it purports to do. Validation is one of the important steps in achieving and maintaining the quality of the final product. If each step of production process is validated, we can assure that the final product is of the best quality. This study is intended to

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45

Biglova, Yu R., N. V. Gadasina, T. N. Bokovikova, et al. "Nonspecific Impurities in Pharmaceutical Substances: Characteristics of Test Methods." Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 9, no. 3 (2019): 153–61. http://dx.doi.org/10.30895/1991-2919-2019-9-3-153-161.

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One of the prerequisites of efficacy and safety of finished pharmaceutical products is the quality of pharmaceutical substances used in their production. Criteria of assessment of pharmaceutical substance purity are determined by the substance composition and production technology, as well as by specific aspects of the finished pharmaceutical product production and use. It is necessary to control the content of nonspecific organic and inorganic impurities, impurities of microbial origin, and residual solvents. The aim of the study was to analyse characteristics of test methods used to determin

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Sharma, Shivani, Swapnil Goyal, and Kalindi Chauhan. "A REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION." International Journal of Applied Pharmaceutics 10, no. 6 (2018): 8. http://dx.doi.org/10.22159/ijap.2018v10i6.28279.

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The top objective of any pharmaceutical industry is to produce products of necessary characteristic and quality reliably, in a cost-effective manner. Development of a method is essential for discovery, development, and evaluation of medicines in the pharmaceutical formulation. The main aim of this review article was to check the development and validation of the procedure employed for the medication from the starting of the formulation to the complete commercial batch of product. At the point when an analytical technique is applied to produce outcomes for the quality of medicine associated sam

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47

Araújo, Fabíola Ornellas de, Reinaldo Giudicci, and João José Martins Simões de Sousa. "Use of natural nanobiotechnological input in a pharmaceutical formulation." Research, Society and Development 9, no. 2 (2020): e185922103. http://dx.doi.org/10.33448/rsd-v9i2.2103.

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The use of naturally occurring nanobiotechnological inputs is essential for human health and the environment. This research is of fundamental importance, given consumers' current awareness of using more natural, sustainable and healthy pharmaceutical ingredients. Thus, there has been a growing demand for more biocompatible pharmaceutical formulations with the body, which should have on their labels no aggression to nature (environment) and no use of animal testing (USP-2018). Thus, consumers want to direct the benefits that come from nature, among other means of knowledge, to their families. T

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Lokarev, Aleksandr, Eleonora Stepanova, Marina Ogay, et al. "Possibility of using thermal water from the Nizhne-Paratunskiye springs of Kamchatka to create pharmaceutical and cosmeceutical compositions." Farmacevticheskoe delo i tehnologija lekarstv (Pharmacy and Pharmaceutical Technology), no. 1 (February 1, 2020): 67–78. http://dx.doi.org/10.33920/med-13-2001-07.

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The purpose was to determine content of the main active components — macro- and microelements — in thermal water, in the intermediate product (concentrate) and in the dosage form (spray). Determining the saturation of the dosage form with active components was the purpose as well. Materials and methods. Thermal water from the Nizhne-Paratunskiye springs of Kamchatka, concentrate from this water, composition with a concentrate of thermal water in the form of spray were used. Determination of the content of calcium and magnesium ions was carried out by titrimetric method on the basis of forming

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Hamill, Heather, Kate Hampshire, Harshada Vinaya, and Pavan Mamidi. "Insights from a qualitative study of the procurement and manufacture of active pharmaceutical ingredients in India." BMJ Global Health 6, Suppl 3 (2023): e011588. http://dx.doi.org/10.1136/bmjgh-2022-011588.

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Medicine supply systems are a crucial part of health systems and access to effective essential medicines is a key pillar of Universal Health Coverage. However, efforts to expand access are compromised by the proliferation of substandard and falsified medicines. The vast majority of research to date on medicine supply chains has focused on the formulation and distribution of the finished product, overlooking the crucial steps of Active Pharmaceutical Ingredient production that precede this. In this paper, we draw on qualitative interviews with manufacturers and regulators in India to take a ‘de

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Gabidova, Alfiya, and Valery Galynkin. "A unified and simplified flow diagram of the production of active pharmaceutical ingredients and the finished dosage form." Pharmacy Formulas 1, no. 1 (2019): 32–37. http://dx.doi.org/10.17816/phf18552.

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The article shows that all biotechnological processes consist of four stages which include the step of obtaining the biomass (micro-organisms), fitosyrya biomass (plants, lichens) and biomass from animal raw materials; obtaining the active pharmaceutical substance; obtaining the final dosage form; storage and sale of APS and SFS. The authors have proposed a unified and simplified process sequence that represents the life cycle of the production of APS and SFR, showing the potential risks. Introduction of the HACCP system at the same time to the GMP system allows the identification of CCPs and

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