Aripiprazole Raw Material Testing Procedure
The active substance is Aripiprazole, an established active substance described in the European Pharmacopoeia (Ph.Eur.). Aripiprazole is a white or almost white powder and practically insoluble in water. Aripiprazole does not exhibit optical isomerism. The substance shows polymorphism and is manufactured as polymorphic.
Aripiprazole Raw Material Testing Procedure is used for both manufacturers of the active substance. The main objective of the ASMF procedure, commonly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property.
ARIPIPRAZOLE RAW MATERIAL STANDARD
ANALYTICAL PROCEDURE
REFRENCE: USP 44, NF 39
APPROVAL BLOCK
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Designation
Signature/Date
Written By:
Quality Control Analyst
Reviewed By:
Qualit...