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Q1C Stability Testing: Requirements for New Dosage Forms
STABILITY TESTING: REQUIREMENTS FOR NEW DOSAGE FORMS ICH Harmonised Tripartite Guideline GENERAL The ICH harmonised Tripartite Guideline on Stability Testing of New Active Substances and Medicinal Products* was issued on October 27, 1993. This document is an annex to the ICH
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admin.ich.org4 ICH Q5C - Stability testing of Biotechnological / Biological products ICH guidelines on stability • Q1A - Stability testing for new drug substances and products (R2 - 2003) •PARENT GUIDELINE. Defines the stability data package for registration of a new molecular entity as drug substance/drug product.
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community.clsi.orgaccelerated stability testing – a stability study designed to increase the rate of chemical or physical degradation of an IVD reagent by using exaggerated environmental conditions (eg, light, temperature, humidity); NOTE: Results from such studies may …
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www.who.intWorking document QAS/17.694 page 3 Introduction and background36 37 38 The Stability testing of active pharmaceutical ingredients and finished 39 pharmaceutical products was published as Annex 2 in the WHO Technical 40 Report Series, No. 953, 2009 (1). 41 42 These regulatory guidelines seek to exemplify the core stability data package 43 required for …
STABILITY TESTING OF ACTIVE SUBSTANCES AND …
www.who.intThe stability studies should be conducted on the active substance packaged in a container closure system that is the same as or simulates the packaging proposed for storage and distribution. 2.1.5 Specification Stability studies should include testing of those attributes of the active substance that are