FDA Publishes Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions – Annex 9: Tablet Friability General Chapter
This annex is the result of the Q4B process for the Tablet Friability General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
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FDA Publishes Q4B Evaluation and Recommendation of Pharmacopeial Texts for Use in ICH Regions – Annex 10: Polycrylamide Gel Electrophoresis General Chapter
This annex is the result of the Q4B process for the Polyacrylamide Gel Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the official pharmacopoeial texts, the section in Ph.Eur. 2.2.31. Electrophoresis entitled “Sodium Dodecyl Sulphate Polyacrylamide Gel Electrophoresis (SDS PAGE)”, JP General Information 23. SDS-Polyacrylamide Gel Electrophoresis, and USP <1056> Biotechnology-derived Articles – Polyacrylamide Gel Electrophoresis, can be used as 120 interchangeable in the ICH regions.
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