药典检验与监管指南
药物赞助人和申请人在申请中应提供辅料、原料药和成品药的标准（即属性、分析程序和合格指标）。
这些标准应符合美国药典/国家处方(USP/NF)、英国药典(BP)、欧洲药典(EP)或日本药典(JP)的质量标准。
药典检验是许多原料药和成品药的标准检测方案。进行检验并符合药典方法所述标准，是原料药和成品药在全球生产、放行和发运的基本要求。
立即与专家交流，获得有关药典检验及遵守监管要求方面的进一步支持。
相关技术文章
- Compendial methods from the USP (United States Pharmacopeia) are widely used in pharmaceutical drug product and raw materials testing. However, not all methods in the USP use modern technologies. In chromatographic methods, it is not uncommon that older brands of columns are specified. Therefore, the USP methods are under continuous revision to improve existing procedures or to allow the user to obtain better results.
- Determination of the progestin medication, Drospirenone, using Purospher® STAR RP-18e Hibar® HPLC column and meeting the system suitability criteria as described in the USP monograph.
- The titer determination or standardization of a titration solution is essential for accurate and reliable titration results.
- Elemental impurities in drug products pose a risk to patient health due to toxicological effects, and their levels should be controlled within acceptable limits. Find analytical methods and materials for impurity assessment.
- This application note describes the LC-MS-based quantitative analysis of known nitrosamine impurities following procedures 1 and 3 as given in USP general chapter <1469>.
- Technical article on Selecting the Right Water Purification System
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相关实验方案
- This paper illustrates the setting up of a Lopinavir assay following European pharmacopoeia guidelines (10.2), and using a shorter column packed with smaller particles. The described assay saves valuable time and improves separation efficiency, which typically translates to better method performance.
- Aripiprazole is an atypical antipsychotic and a partial dopamine agonist. It is primarily used in the treatment of schizophrenia, bipolar disorder, major depressive disorder, tic disorders, and irritability associated with autism. Aripiprazole was first approved by the U.S. Food and DrugAdministration in November 2002 for schizophrenia and by the European Medicines Agency in June 2004 for acute manic and mixed episodes associated with bipolar disorder.
- Under applied conditions, system suitability criteria are met, and the Chloroquine Phosphate HPLC Assay and Impurity Profiling Methods demonstrate good resolution/selectivity, reproducibility, and sensitivity.
- Folic acid or folate is classified as a B vitamin (B9). Folic acid is synthetically produced, and used in fortified foods and supplements. Folate is converted by humans to dihydrofolate (dihydrofolic acid), tetrahydrofolate (tetrahydrofolic acid), and other derivatives, which have various biological activities.
- Sildenafil, sold under the brand name Viagra, among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension.
- Following GB method for Vitamin A and Vitamin E as it is written with a 250 x 4.6 mm Ascentis® Express C30 column gives baseline resolution between the critical pair (gamma-, and beta-tocopherol; peaks 3 and 4).
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