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Relevant bibliographies by topics / Impurity quantitation

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Journal articles

Academic literature on the topic 'Impurity quantitation'

Author: Grafiati

Published: 4 June 2021

Last updated: 17 February 2022

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Journal articles on the topic "Impurity quantitation"

1

Mule, Kishorkumar L., and Dnyandeo B. Pathare. "DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ISOSULFAN BLUE BY LIQUID CHROMATOGRAPHY." International Journal of Applied Pharmaceutics 9, no. 2 (2017): 42. http://dx.doi.org/10.22159/ijap.2017v9i2.16904.

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Objective: To develop and validate new, simple and rapid analytical method for determination of related impurities in isosulfan blue drug substances by the liquid chromatographic method as per ICH guidelines.Methods: The chromatographic separation obtained between drug substance i.e. isosulfan blue and its related impurities (Impurity-A, Impurity-B and Impurity-C) on C18 (100 x 2.00 mm) 1.9µ UPLC column using a mobile phase system containing 0.1 % perchloric acid in water (Mobile phase A) and 0.1 % perchloric acid in mixture of 30 volumes of water and 70 volumes of acetonitrile (Mobile Phase B

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2

Casella, R., S. Boudreau, James A. Wesley, and Robert D'Aloise. "Quantitative measurement of crystalline impurity in a pharmaceutical tablet by X-ray powder diffraction and method validation." Powder Diffraction 28, no. 3 (2013): 222–30. http://dx.doi.org/10.1017/s0885715613000432.

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A powder X-ray diffraction method was developed and validated to measure the crystalline impurity 4-(5-cyclopentyloxy-carbonylamino-1-methyl-indol-3-ylmethyl)-3-methoxy-N-o-tolylsulfonylbenzamide hydrate in a pharmaceutical tablet ranging from 0.6 to 3% (w/w). The calibration plot was found to be linear with a correlation coefficient (r2) of 0.996, and was reproducible among operators. The detection limit was determined to be 0.6% with a signal-to-noise ratio of 3:1. The quantitation limit was determined to be 1% with a signal-to-noise ratio of 5:1. Instrument precision at the quantitation lim

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3

Lasdun, A. M., R. R. Kurumbail, N. K. Leimgruber, and A. S. Rathore. "Validatibility of a capillary isoelectric focusing method for impurity quantitation." Journal of Chromatography A 917, no. 1-2 (2001): 147–58. http://dx.doi.org/10.1016/s0021-9673(01)00662-8.

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4

Denton, Justin R., Renee K. Dermenjian, and Bing Mao. "Development of an enantiomeric separation of d & l valine as their corresponding isoindole adducts by RP-HPLC for utilization of the l-valine toward pharmaceutically relevant materials." Anal. Methods 6, no. 16 (2014): 6565–70. http://dx.doi.org/10.1039/c4ay01069h.

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5

Nath, Dipankar, and Bidhya Sharma. "Impurity Profiling-A Significant Approach in Pharmaceuticals." Current Pharmaceutical Analysis 15, no. 7 (2019): 669–80. http://dx.doi.org/10.2174/1573412914666181024150632.

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There has been ever increasing interest in impurities present in Active Pharmaceutical Ingredient’s (API’s). Nowadays, not only purity profile but also impurity profile has become mandatory according to the various regulatory authorities. In the pharmaceutical world, an impurity is considered as an inorganic or organic material, or residual solvents other than the drug substances, or ingredients, arising out of synthesis or unwanted chemicals that remains with APIs. Impurity profiling includes identification, structure elucidation and quantitative determination of impurities and degradation pr

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6

Kuz’mina, Nataliya E., Sergey V. Moiseev, Mikhail D. Khorolskiy, and Anna I. Lutceva. "Development and Validation of 2-Azaspiro [4,5] Decan-3-One (Impurity A) in Gabapentin Determination Method Using qNMR Spectroscopy." Molecules 26, no. 6 (2021): 1656. http://dx.doi.org/10.3390/molecules26061656.

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The authors developed a 1H qNMR test procedure for identification and quantification of impurity A present in gabapentin active pharmaceutical ingredient (API) and gabapentin products. The validation studies helped to determine the limit of quantitation and assess linearity, accuracy, repeatability, intermediate precision, specificity, and robustness of the procedure. Spike-and-recovery assays were used to calculate standard deviations, coefficients of variation, confidence intervals, bias, Fisher’s F test, and Student’s t-test for assay results. The obtained statistical values satisfy the acc

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7

Castro-Puyana, María, Carmen García-Ruiz, Alejandro Cifuentes, Antonio L. Crego, and Maria Luisa Marina. "Identification and quantitation of cis-ketoconazole impurity by capillary zone electrophoresis–mass spectrometry." Journal of Chromatography A 1114, no. 1 (2006): 170–77. http://dx.doi.org/10.1016/j.chroma.2006.02.030.

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8

Mount, Dwight L., James W. Miles, and Frederick C. Churchill. "Liquid Chromatographic and Spectroscopic Characterization of Pentamidine Isethionate and Impurities in Bulk Drug and Injectables." Journal of AOAC INTERNATIONAL 69, no. 4 (1986): 624–29. http://dx.doi.org/10.1093/jaoac/69.4.624.

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Abstract A liquid chromatographic (LC) method is described for evaluating purity of pentamidine isethionate (PI), a life-saving drug used in the treatment of Pneumocystis carinii pneumonia, which is a leading cause of death in persons with acquired immunodeficiency syndrome (AIDS). Six potential impurity compounds were synthesized to test the selectivity of the chromatographic system and to permit quantitation of impurities in various lots of PI products. The drug and impurities were separated with gradient elution on a cyano-bonded LC column. The analytic system provided information on the id

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9

Raja, K. Durga, V. Saradhi Venkata Ramana, K. Raghu Babu, et al. "Development and Validation of UPLC-ESI-MS/MS Technique for the Determination of 2-Isopropyl-4-(chloromethyl)thiazole in Ritonavir." Asian Journal of Chemistry 32, no. 7 (2020): 1733–40. http://dx.doi.org/10.14233/ajchem.2020.22677.

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The objective of this work was to develop and validate a rapid, highly sensitive ultra performance liquid chromatography-tandem mass spectrometry (UPLC-ESI-MS/MS) method for the quantification of 2-isopropyl-4-(chloromethyl)thiazole in ritonavir. Chromatographic conditions of this impurity were achieved on an AQUITY UPLC column HSS (high strength silica) T3 column (100 mm long, 2.1 mm internal diameter, 1.8 μm diameter) using a gradient elution with 0.1% formic acid in water and methanol at a flow rate of 0.3 mL/min. LCMS/MS was operated under the multiple reaction mode (MRM) using electrospra

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10

bhatale, Mohan, Neelakandan kaliyaperumal, Gopalakrishnan Mannathusamy, and Gurunathan ramalingam. "Development and Validation of Estimation of Genotoxic Impurity (Triethyl orthoformate content) in 5-methyl-4-isoxazole carboxylic acid (5-MIA) by using GC Technique." Oriental Journal Of Chemistry 37, no. 2 (2021): 348–53. http://dx.doi.org/10.13005/ojc/370212.

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A simple, selective, precise and accurate Gas chromatographic method for determination of Triethyl orthoformate content (Genotoxic impurity) in 5-MIA is reported. The GC method development and validation as per the International Council for Harmonisation (ICH) guidelines Q2(R1). The effective chromatographic separations were achieved on DB-624, 60 m × 0.53 mm ID, with film thickness of 3.0 μm (Fused silica capillary column), Capillary injector temperature of 150°C, and Nitrogen Carrier gas. This method is unique as there is no UV response; hence GC Method was developed for Triethyl orthoformat

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