Determination of Organic Impurities from Valproic Acid as per proposed USP monograph GC method

User Benefits

- Shimadzu Nexis GC-2030 can be effectively used for organic impurities test of valproic acid drug substance as per the proposed USP monograph GC method. - The Nexis GC-2030 easily meets the acceptance criteria as per the proposed USP monograph for valproic acid

Introduction

Valproic acid, or valproate, is a fatty acid derivative and anticonvulsant originally used as a popular organic solvent in industry and pharmaceutical manufacturing for nearly a century, Currently it is a compound of interest in the field of oncology for its anti-proliferative effects and is the subject of many clinical trials in a variety of cancer types. It is on the World Health Organization's List of Essential Medicines and is available as a generic medication. The impurities such as valproic acid impurity B & valproic acid impurity K originate through the manufacturing process of valproic acid. Their presence should be controlled in finished valproic acid drug substance, this led United States Pharmacopeia (USP) to incorporate a gas chromatography procedure named “Organic Impurities” in the proposed new monograph for valproic acid below are the changes proposed in the upcoming monograph. 1. Revision of organic impurities test to add valproic acid related compound K with an acceptance criteria of NMT 0.15%, using USP G35 stationary phase. 2. Addition of USP valproic acid related compound K RS 3. Deletion of USP valproic acid related compound A RS This application note demonstrates the determination of organic impurities from valproic acid as per proposed USP monograph GC method using Shimadzu’s Nexis GC-2030 system. Nexis GC-2030, Key features - Tool-free Column Installation - One-Touch Inlet Maintenance - Remote Operations and Monitoring - Achieves Exceptional Reproducibility (AFC with CPU) - Best-in-class sensitivity for most of the detectors

January 24, 2023 GMT