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ICH Topic Q 3 A Impurities Testing Guideline: …
www.pharma.gally.chCPMP/ICH/142/95 4/11 (i.e., 0.1%), for the purpose of these guidelines, such values would not be rounded to 0.1% and these impurities would not require identification.
ICH Topic Q 1 A Stability Testing Guidelines: …
www.pharma.gally.chCPMP/ICH/380/95 1/13 STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS ICH Harmonised Tripartite Guideline …