Do USP analytical methods need validation?

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Md. Saddam Nawaz

Dear Mr. Fuad- Al-Rimawi,

Pharmacopeia methods usually need verification rather validation. You can see USP chapter "Verification of Compendial Procedures 1226" and table 2 in chapter 1225.

Best regards.

Omar S. A. Al-Khazrajy

Dear Dr Fuad,

Not just USP but also some BP and EUP methods need for validation.

Kindest regards.

Ramkumar Ponnuraj

With my knowledge its not required unless if you follow the exact procedure including the mobile phase and all parameters described in the monograph.