Active pharmaceutical ingredients stability testing

A written stability-testing programme should be established for active pharmaceutical ingredients. Stability-indicating methods should used. 

Reliable quality control in the field of pharmaceutical analysis is based on the use of valid analytical methods. For this reason, any analytical procedures proposed for a particular active pharmaceutical ingredient and its corresponding dosage forms shonld be validated to demonstrate that they are scientifically sonnd nnder the experimental conditions intended to be used. Since dissolntion data reflect drng prod-net stability and quality, the HPLC method used in snch tests shonld be validated in terms of accuracy, precision, sensitivity, specificity, rngged-ness, and robustness as per ICH guidelines. 

Complete Chemistry, Manufacturing, and Control (CMC) information provided, including evidence of purity, stability, toxicology testing, and integrity of active pharmaceutical ingredient (API), placebo, and final product. 

Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Page 24 The test procedures used in stability testing should be vahdated and be stability-indicating... 

WHO Stability testing of active pharmaceutical ingredients and pharmaceutical products QAS/06.179/Rev.2 DRAFT... 

Stability testing of active pharmaceutical ingredients and finished pharmaceutical products. Annex 2, World Health Organization, Expert Committee on Specification for Pharmaceutical Preparation, 43rd Report, Technical Report Series No. 953, p. 87, 2009. http //apps.who.int/bookorders/ MDIbookPDF/Book/11000953.pdf. 

Part II relates to the quality of the product and gives details of its chemical, pharmaceutical and biological testing. Data should be provided in respect of qualitative and quantitative particulars of the constituents, description of the method of preparation, control of starting materials, control tests on intermediate products, control tests on the finished product and stability tests. In cases where the active ingredient is made by a manufacturer other than the applicant or the product manufacturer, some of the information required in Part II may be presented in a separate file, the Drug Master File, to maintain the confidential nature of the synthetic process. 

Since 1 January 2(X)1, this product category has been subject to a quasi-pharmaceutical registration procedure. The dossier to be submitted to the Korean authorities (i.e. Korean Food and Drug Administration, KFDA) must include, notably, specifications of the final product, titration of active ingredients in the cosmetic, a stability test performed according to the Korean protocol 3 batches over 6 months at 40 °C and 75% humidity, with analysis of active ingredients and preservatives each two months during these 6 months. 

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