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Academic literature on the topic 'Tacrolimus Validation ICH Guidelines'

Author: Grafiati
Published: 4 June 2025
Last updated: 14 July 2025

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Journal articles on the topic "Tacrolimus Validation ICH Guidelines"

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Camargo, Guilherme A., Amanda M. Lyra, Fernanda M. Barboza та ін. "Validation of Analytical Methods for Tacrolimus Determination in Poly(ε-caprolactone) Nanocapsules and Identification of Drug Degradation Products". Journal of Nanoscience and Nanotechnology 21, № 12 (2021): 5920–28. http://dx.doi.org/10.1166/jnn.2021.19500.

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The aim of this paper was to use chromatographic tools for validating an analytical method for the tacrolimus (TAC) determination in polymeric nanocapsules and for identifying the drug degradation products after alkaline stress. A rapid Ultra-High-Performance Liquid Chromatography coupled with photo-diode array (UHPLC-PDA) method was successfully performed using the following chromatographic conditions: the Shimadzu Shim-pack XR-ODS III C18 column (100 mm×2.00 mm, 2.2 μm), the mobile phase consisting of methanol and acidified ultrapure water (89:11 v/v), the flow rate of 0.55 mL·min−1, and the ultraviolet (UV) detection at 235 nm. This method was validated as per International Council for Harmonisation (ICH) guidelines. In addition, a TAC forced degradation assay was carried out after alkaline stress and its degradation products were investigated using Liquid Chromatography coupled tandem mass spectroscopy (LC-MS/MS). The calibration curve was linear in the range of 100.0–300.0 μg·mL−1 (r >0.9999). Accuracy was confirmed by the TAC recovery of 96.55 to 98.19%. Precision (intraday and interday) were demonstrated by relative standard deviation lower than 0.89% and 3.25%, respectively. Selectivity and robustness were also proved. The method developed it was successfully applied to quantify TAC from polymeric nanocapsules, showing a high loading efficiency rate (>96.47%). The main drug degradation product observed in a multiple reaction monitoring (MRM) experiment was m/z 844, confirming the susceptibility of TAC under alkaline conditions; this finding was first time described.
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Bhatia, Ritika, Rakesh Goyal, and Dilip Agarwal. "Process Validation of Paracetamol tablet as per ICH guidelines." International Journal of Medical and Biomedical Studies 7, no. 6 (2023): 11–23. http://dx.doi.org/10.32553/ijmbs.v7i6.2713.

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Process validation is an integral part of pharmaceutical manufacturing, ensuring that tablets are consistently produced with quality and efficacy in line with regulatory requirements. The International Council for Harmonization ICH) provides guidelines for the systematic validation of manufacturing processes. This research article presents a comprehensive study on process validation for Paracetamol tablets following the ICH guidelines. The article focuses on various aspects of the validation process, including process design, qualification, and continued process verification, with specific emphasis on Paracetamol tablet manufacturing. Experimental studies were conducted to characterize the critical process parameters and assess their impact on the tablet's quality attributes. The article also discusses the use of statistical analysis techniques for data evaluation and demonstrates the establishment of a robust validation protocol for Paracetamol tablet manufacturing. Through the application of the ICH guidelines, this research contributes to ensuring the consistency and reliability of Paracetamol tablets, enhancing patient safety and meeting regulatory expectations.
 Keywords: Process validation, ICH guidelines, Critical process parameters, Critical Process Attribution, Statistical analysis, and validation protocol;
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Elumalai, Selvaraja, Venkata Lakshamana Sagar Dantinapalli, and Mylsamy Palanisamy. "Comparative Analysis of Analytical Method Validation Requirements Across ICH, USP, ChP and ANVISA: A Review." Journal of Pharmaceutical Research International 36, no. 12 (2024): 54–71. http://dx.doi.org/10.9734/jpri/2024/v36i127628.

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This comprehensive guide provides a detailed comparison of analytical method validation requirements across four major regulatory bodies: the International Council for Harmonisation (ICH), United States Pharmacopeia (USP), Chinese Pharmacopoeia (ChP), and Brazilian Health Regulatory Agency (ANVISA). The study examines key aspects of method validation, including scope, validation parameters, acceptance criteria, and regulatory compliance. These guidelines have been chosen due to major differences between regulations requirements and ICH guidelines, leading to a huge challenge for the Health Authority and the locally established Pharmaceutical Companies to implement these guidelines. Implementing the revised or upcoming ICH guidelines will benefit the industry and health authorities. Recent revisions by the guidelines will help to align with other chosen regulatory authorities to reduce duplicate work and contribute to the global regulatory harmonization, which will bring a great benefit to the regulatory bodies review process, industrialist approval and important medicines approval will be faster available to the patients.
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Bhatia, Ritika, Mo Firoj Tanwar, Rakesh Goyal, and Dilip Agarwal. "Process Validation of Paracetamol Tablets: A Comprehensive Study Based on ICH Guidelines." International Journal of Medical and Biomedical Studies 7, no. 6 (2023): 01–10. http://dx.doi.org/10.32553/ijmbs.v7i6.2712.

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This research paper aims to provide a comprehensive understanding of the process validation of Paracetamol tablets according to the guidelines outlined by the International Council for Harmonisation of Technical Requirements forPharmaceuticals for Human Use (ICH). Paracetamol is a widely used analgesic and antipyretic drug, and ensuring the quality, safety, and efficacy of its dosage form is of utmost importance. This study encompasses the three stages of process validation, namely process design, process qualification, and continued process verification, with a focus oncritical parameters and attributes. The article also explores the role of regulatory guidelines, such as the ICH Q8 (R2), Q9,and Q10, in facilitating effective process validation. (1)
 Key words: Process Validation, ICH, CPP, CQA, SPC, Change Control, VMP;
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5

Sahu, Sandeep, and Narendra Kumar Lariya. "Development and Validation of Spectrophotometric Method for the Estimation of Enoxaparin sodium in marketed formulation." Journal of Drug Delivery and Therapeutics 9, no. 4-s (2019): 1236–39. http://dx.doi.org/10.22270/jddt.v9i4-s.3972.

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Simple, cost effective, precise and accurate UV-Spectrophotometric method for estimation of Enoxaparin sodium was developed and validated as per ICH guidelines. This Method involves solving of calibration curve based on measurement of absorbance wavelengths 234nm in 0.1 N HCl. The method obeys the Beer’s law in the concentration ranges 100-500µg/ml. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. % Recovery for both the drugs were in the range of 99.288 99.632% indicating excellent accuracy with percentage RSD Values less than 2. The method was precise, with a relative standard deviation of less than 2% for all tha validation parameters. Thus, method can be used for routine monitoring of drugs in industry for the assay of bulk drugs and commercials.
 Keywords: UV-Spectrophotometric, Enoxaparin sodium, Validation, ICH guidelines
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JAGIRAPU, BANGARUTHALLI, U. Harini, M. Divya, and P. Sushma. "Simultaneous estimation of telmisartan and atorvastatin calcium in API and tablet dosage form." Journal of Drug Delivery and Therapeutics 9, no. 1 (2019): 175–79. http://dx.doi.org/10.22270/jddt.v9i1.2268.

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A new method has been established for the simultaneous estimation of Telmisartan and Atorvastatin calcium by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Telmisartan and Atorvastatin calcium by using boston ODS C18 column, flow rate was 1.0ml/min, mobile Phase consists of methanol:Acetonitrile:buffer in ratio of 35:25:40. Detection wave length was 235nm.The instrument used was SHIMADZU HPLC auto sampler. The retention time of Atorvastatin calcium and Telmisartan was found to be 2.350 and 3.490 minutes respectively. The analytical method was validated according to ICH guidelines (ICH Q2b). The correlation coefficient (r2) was found to be 0.997 and 0.999 for Telmisartan and Atorvastatin calcium respectively. % mean recovery was found to be 100.943% and 100.576% for Telmisartan and Atorvastatin calcium respectively. %RSD for precision on replicate injection was 0.46 and 0.70 for Telmisartan and Atorvastatin calcium respectively. The validation study was found to be precise, robust, and repeatable.
 Keywords: Telmisartan, Atorvastatin calcium, ICH guidelines, Validation.
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Mandhare, Shubham, Rahul Godge, Akshay Vikhe, and Shubham Talole. "Development and validation of a QbD-based RP-HPLC method for vericiguat quantification." Journal of Applied Pharmaceutical Research 12, no. 2 (2024): 57–67. http://dx.doi.org/10.18231/j.joapr.2024.12.2.57.67.

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Aim: An RP-HPLC method for Vericiguat using the QbD approach was developed and validated by ICH guidelines. Method: The ICH (Q2R1) guidelines have been followed in the development and validation of an RP-HPLC technique by considering several validation parameters like linearity, precision, LOD, LOQ, and accuracy. The study was performed on Agilent Tech using the C18 column (4.6x250 mm; 5 µm) and Chemstation 10.1 software with statistical data analysis, and the detector used was UV (DAD). Results: The mobile phase used for separation was Methanol: 0.1% OPA in the ratio of (76:24) at room temperature, the flow rate was 0.8ml/min, and the wavelength was 331nm. The results indicated that the quantification limit was 0.7209 µg/ml, and the detection limit was 0.2379 µg/ml. Conclusion: The validation studies confirmed that the developed method is fast, accurate, precise, cost-effective, selective, and useful for routine analysis of vericiguat in tablet dosage forms.
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Ahirwar, Sonu, Varsha Kashaw, Ravish Sahu, Surbhi Chourasia, Vaibhav Rajoria, and Prakash Kushwaha. "UV Spectrophotometric Method Development and Validation of Butorphanol Tartrate in Bulk Drug and Pharmaceutical Formulation." Journal of Drug Delivery and Therapeutics 14, no. 4 (2024): 77–80. http://dx.doi.org/10.22270/jddt.v14i4.6521.

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The present research work discusses the development and validation of a UV spectrophotometric method for butorphanol tartrate. Simple, accurate and cost efficient spectrophotometric method has been developed for the estimation of butorphanol tartrate in tablet dosage form. The optimum conditions for the analysis of the drug were established. The maximum wavelength (λ max) was found to be 278nm. The percentage recovery of butorphanol tartrate was in the 100.016±0.68. Beers law was obeyed in the concentration range of 2-12μg/ml. Calibration curves shows a linear relationship between the absorbance and concentration. The line equation y = 0.0674x - 0.0057 with r2 of 0.9998was obtained. Validation was performed according to ICH guidelines for linearity, accuracy, precision, LOD and LOQ. The sample solution was stable up to 36 hours. The proposed method may be suitable for the analysis of butorphanol tartrate in tablet formulation for quality control purposes.
 Keywords: Butorphanol tartrate, Validation, Precision, Accuracy, LOQ, LOD, ICH guidelines.
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Shantappa Birajdar, Arunadevi. "New Method Development by HPLC and Validation as per ICH Guidelines." Acta Scientific Pharmaceutical Sciences 4, no. 4 (2020): 55–60. http://dx.doi.org/10.31080/asps.2020.04.0517.

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Akram, N. Md, and M. Umamahesh. "ICH Guidelines on Method Development and Validation by RP-HPLC Method." Journal of Chemistry and Chemical Sciences 7, no. 12 (2017): 1179–82. http://dx.doi.org/10.29055/jccs/526.

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Book chapters on the topic "Tacrolimus Validation ICH Guidelines"

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Borman, Phillip, and David Elder. "Q2(R1) Validation of Analytical Procedures." In ICH Quality Guidelines. John Wiley & Sons, Inc., 2017. http://dx.doi.org/10.1002/9781118971147.ch5.

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"Method Validation and Documentation (Procedure 5)." In SIFT-MS. Royal Society of Chemistry, 2025. https://doi.org/10.1039/9781837677917-00281.

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As a chromatography-free analytical technique, selected ion flow tube mass spectrometry (SIFT-MS) speciates and quantifies volatile compounds in the gas phase using a very different approach to traditional laboratory techniques. Nevertheless, as described in this chapter, guidelines for analytical method validation, such as ICH Q2(R1), are readily adapted to both automated headspace-SIFT-MS analysis and less conventional SIFT-MS approaches. Additionally, recommendations are made for documentation of SIFT-MS methods for quality systems and routine use.
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Kasangaki, Wilberforce. "Method Validation and Verification." In Analytical Methods for Drug Development. THINKPLUS PHARMA PUBLICATIONS, 2025. https://doi.org/10.69613/28x3yy16.

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Method validation establishes analytical procedure reliability through systematic performance evaluation. ICH Q2(R1) guidelines provide validation frameworks adaptable across development phases from early research through commercialization. Risk-based approaches align validation effort with method purpose and product criticality. Validation parameters include specificity testing against potential interferents, linearity across concentration ranges, accuracy through recovery studies, precision at repeatability and intermediate levels, detection and quantitation limit determination, and robustness evaluation through deliberate parameter variations. Statistical analysis applies outlier testing, equivalence assessment, measurement uncertainty calculation, and confidence interval determination to validation data, enabling science-based acceptance criteria. Method transfer between laboratories requires comparative testing protocols with predefined acceptance criteria and troubleshooting pathways for failed transfers. Documentation encompasses validation protocols, comprehensive reports, and lifecycle management plans including change control triggers and revalidation requirements.
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Desai, Saloni S., Sejal M. Khuman, and Jeshika B. Patel. "HIGH PERFORMANCE LIQUID CHROMATOGRAPHY." In Emerging Pharmaceutical Sciences: Today and Tomorrow. Iterative International Publishers, Selfypage Developers Pvt Ltd, 2024. http://dx.doi.org/10.58532/nbennurch334.

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One type of column chromatography that is commonly used in biochemistry and analysis for the purpose of separating and quantify active compounds is called High Performance Liquid Chromatography (HPLC). HPLC is a frequently employed separation technique that is utilized to determine, separate, and measure the medication. In addition to a variety of various human and animal study, the development and validation of highperformance liquid chromatography techniques play critical roles in innovative drug identification, development, and production. The several steps needed in creating and verifying an HPLC procedure are covered in this chapter. Among other things, the chemical structure of the molecules, their synthesis pathway, the solubility of polarity, the pH and pKa values, and the activity of functional groups influence the development of an HPLC technology. The validation of a High Performance Liquid Chromatography method includes the consideration of multiple variables, including precision, sensitivity, linearity, range, robustness, system adaptability, limit of detection and limit of quantification, and ICH Guidelines
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K, Shah Chandra, Dr Dedania Zarna, Dr Dedania Ronak, and Dr Jain Vineet C. "ANALYTICAL QBD APPROACH TO HPLC METHOD DEVELOPMENT AND VALIDATION FOR PREGABALIN." In Futuristic Trends in Pharmacy & Nursing Volume 3 Book 19. Iterative International Publisher, Selfypage Developers Pvt Ltd, 2024. http://dx.doi.org/10.58532/v3bgpn19p1ch6.

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Analytical QbD helps to provideanalytical life cycle management by systemic method development and maintenance. An efficient CCD - Central Composite Design was developed at 23 factorial designs; mobile phase composition and pH kept as two different factors at law(-1), medium(0) and high(+1) at three levels for RP-HPLC method. The response to be evaluated being retention time, peak asymmetry and theoretical plates. The chromatographic separation conditions were optimized with the Design Expert Software version10.0.1.0, i.e. Inertsil ODS column C18 (250×4.6mm, 5.0µm), mobile phase used werephosphate buffer: methanol: acetonitrile (92:5:3, v/v/v) adjusted to pH 5. The flow rate was set 1.2 ml/min and210 nm was set as detection wavelength with PDA detector.The above chromatographic condition for elution, Pregabalin was found to beeluted at 6.083 min of retention time. The linearity of developed RP-HPLC method was from 200-1000 µg/ml with r2 = 0.9992.The system suitability parameters were; 0.916 as value of tailing factor and 4238 as value of theoretical plates. The % RSD for inter day and intraday precision with 0.0112-0.0225 and 0.0058- 0.0182 respectively. The %RSD forprecision and robustness values were observed less than 2% indicate the preciseness of developed method. The assay results from pharmaceutical dosage form with 100.01 ± 0.72 %w/w. The chromatographic peak purity indicate only pregabalin peak at observed retention time and any other peaks were absent.The results of all the validation parameters were as per ICH guidelines within the acceptance criteria.This experiment provides a better knowledge of the parameters that improve chromatographic separation with more dependence on the capabilities of the created HPLC technique to meet their intended demand.It gives practical information understanding that aids in the construction of chromatographic optimization for future application. The QbD technique of method development has aided in the understanding of method variables, lowering the probability of failure during method validation and transfer.
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Rajasekhar, K., Ch Gangu Naidu, Ch Naga Sesha Sai Pavan Kumar, K. Varaprasada Rao, and Y. Srinivasa Rao. "Development and Validation of A RP-HPLC Method for the Simultaneous Determination of Twenty Related Substances of Sulfamethoxazole and Trimethoprim in Injection Dosage Form." In Current Trends in Drug Discovery, Development and Delivery (CTD4-2022). Royal Society of Chemistry, 2023. http://dx.doi.org/10.1039/9781837671090-00246.

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A simple, robust and for the quantification of experimentally 20 related impurities of sulfamethoxazole (SM) and trimethoprim (TM) in liquid pharmaceutical dosage form, a novel RP-HPLC method was developed. Utilizing gradient elution on a Kromasil 100-5-C18; 5.0 m, (4.0x250) mm, column, chromatographic separation was accomplished. Solvent A (solution of 0.08% orthophosphoric acid in water) and Solvent B (mixture of acetonitrile and methanol, 80:20 v/v), given at a flow rate of 0.8 ml/min, respectively, make up the mobile phase. Using a photodiode array (PDA) detector, the analytes were identified and measured at 210 nm. Eight Sulfamethoxazole-related impurities and twelve Trimethoprim-related impurities can be quantified and evaluated using an organic impurities technique. According to the ingredients of the injection dosage form, the LOQ Standard solution concentration for Sulfamethoxazole Impurities is 0.0016 mg/mL and for Trimethoprim Impurities is 0.00032 mg/mL. For the OI process, the sample’s nominal concentrations of trimethoprim and sulfamethoxazole are 0.32 mg/mL and 1.6 mg/mL, respectively. The Validation range of the procedure was examined for test concentrations ranging from 0.1% to 1.0%. For all the stated contaminants, LOQ solution and LOQ spiked sample solution are stable for 24 hours at 5 °C sample temperature. At a sample temperature of 5°C, Trimethoprim EP Impurity-H is stable for up to 12 hours. According to ICH recommended guidelines, the method was validated, and it proved to be accurate and exact (repeatability and intermediate precision level) within the corresponding linear range of known SM and TM impurities.
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Conference papers on the topic "Tacrolimus Validation ICH Guidelines"

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Velјanova Martinoski, Elena. "QUALITY RISK MANAGEMENT - REGULATORY FRAMEWORK." In XX International Convention on Quality JUSK ICQ 2024. United Association of Serbia for Quality, 2024. http://dx.doi.org/10.46793/jusk-icqxx.058vm.

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t is known that at the time of drug safety approval, the amount of information is relatively limited. We are all witnessing a time when everything is very dynamic, a time of complete digitization and automation, where information’s are easily available. Additionally, the COVID-19 virus pandemic has forced rapid drug development and easy availability of drugs for patients. Dynamics carries many risks, so risk management techniques, although well known to the pharmaceutical industry, are becoming an increasingly popular and used tool. Risk management regulation is defined in EU and FDA quality guidelines, ISO 14385, ISO 14971, ISPE documents, and even in the ISO 9001:2015 revision, which shows how to establish and maintain a risk management system. Assessment of individual risks related to specific products and starting materials, and identification of hazards at certain stages of production or distribution should enable regulatory authorities to improve drug control. This includes the appropriate application of root cause analysis that can identify and address the root cause(s). The recent revision of ICH Q9 focuses on six specific topics, subjectivity in QRM, product availability risks, formality in QRM, risk-based decision making, risk review, and hazard (root cause) identification. The ICH Q9 revision leads to better, science-based manufacturing operations, control strategies, and validation activities, which can indirectly lead to fewer quality defects and drug recalls, and potentially lower costs for the pharmaceutical industry and healthcare systems.
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Tymofiienko, Mykhailo, and Liudmila Butsenko. "A development of a fast chromatographic method for indoleacetic acid determination in cell cultures." In VI International Conference on European Dimensions of Sustainablе Development. National University of Food Technologies, 2024. https://doi.org/10.24263/edsd-2024-6-34.

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This study presents the development and validation of a novel high-performance liquid chromatography method employing fluorescence detection for the rapid determination of indoleacetic acid (IAA) in bacterial cell cultures. IAA, a pivotal plant growth hormone, influences various physiological processes and is often employed as a marker to screen the growth-promoting properties of rhizosphere and endophytic bacteria. Current methods for IAA determination face challenges such as lengthy and costly sample preparations, complex matrix interferences, and the need for expensive equipment. This method utilizes simple sample preparation and rapid analysis procedures, mitigating previous limitations. The method’s performance was assessed using two bacterial strains, Bacillus subtilis 26D and Bacillus amyloliquefaciens IMV A4. The method was also validated according to ICH guidelines, confirming specificity, linearity, accuracy, and repeatability. The developed method demonstrated significant improvements in speed and environmental impact, utilizing minimal solvent volumes and offering quick turnaround times. This method is a valuable tool for the rapid screening of bacterial strains for IAA production, facilitating the optimization of growth conditions in agricultural biotechnology applications.
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