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OOS Investigation for Esomeprazole Mg USP by Ram is a document available to read on EtoBox.

1. Esomeprazole sample RM180069 failed HPLC testing for related compound A and total impurities. 2. An investigation team analyzed instruments, reagents, analyst qualifications, method, raw data, glassware and environment. No errors were found. 3. The vendor suggested repeating tests using amber vials for mobile phase, sample and standard preparation. Based on the investigation and vendor input, the team will retest the sample.

Author

Ram

Language

EN