局方試験と規制ガイダンス
医薬品の治験依頼者および申請者は、申請書において、添加剤、原薬および製剤に関する仕様（すなわち特性、分析手法、許容基準）を提示することが求められています。
これらの仕様は、米国薬局方／国民医薬品集（USP/NF）、英国薬局方（EP）、欧州薬局方（EP）、または日本薬局方（JP）の品質基準を遵守しなければなりません。
局方試験は、多くの医薬品原材料および最終製品に対する標準化されたプロトコルです。薬局方詳述されたこれらの試験および基準遵守は、医薬品成分および製剤に関する基本的な要求事項です。
局法試験の実施と規制要件については、是非メルクの専門家にご相談ください。
関連技術資料
- 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
- すべて表示 (15)
関連プロトコル
- 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).
技術資料・プロトコルの検索
ハイライト
溶解試験を成功させるためのクイックガイド今すぐダウンロード
医薬品開発から上市まで、このインタラクティブなPDFでは、溶解試験プロトコル用の信頼できる一貫性のあるフィルターと試薬が幅広く取り上げられています。
ウェビナー - The Value of Pharmacopeial Reference Standards今すぐご覧ください
このプレゼンテーションでは、薬局方収載基準の具体的な価値の高度な概要を説明します。
ウェビナー - Leverage the Full Potential of Pharmacopeia Regulated U/HPLC Method Adaption to Increase Lab Effectiveness今すぐご覧ください
U/HPLC法を改良して医薬品分析の生産性を高め、コストを抑える戦略をご覧ください。
ログインして続行
続きを確認するには、ログインするか、新規登録が必要です。
アカウントをお持ちではありませんか？