The Indian Pharmacopoeia Commission (IPC) on June 25, 2026, issued the Indian Pharmacopoeia (IP) 2026 – Amendment List 01.
The following has been stated:
• It has issued Amendment List 01 to the 10th Edition of IP 2026, effective July 01, 2026, to revise and clarify pharmacopoeial standards based on scientific inputs. The amendments update analytical methods, impurity limits, dissolution procedures, assay parameters, identification tests, and quality specifications for several drug substances and formulations, including Aciclovir, Azilsartan Kamedoxomil, Clarithromycin, Dextrose, Menthol, Metformin Hydrochloride, Nitrofurantoin, Phenytoin Tablets, Pregabalin Capsules, Interferon Beta-1a Injection, and various biological and veterinary products.
• Significant changes include revised impurity limits, updated chromatographic and dissolution methods, expanded testing requirements for pyrogens and biological products, modified pH and moisture specifications, and revised vaccine safety and potency testing standards. Additionally, new dissolution methods for Dapagliflozin & Metformin Hydrochloride Prolonged-release Tablets and Vildagliptin & Metformin Prolonged-release Tablets will become effective from December 01, 2026.
• The amendments aim to strengthen product quality, testing accuracy, and regulatory compliance, and all stakeholders are required to implement the revised standards from the applicable effective dates.
[Notification no. - T.11015/01/2020-AR&D]
