IPC releases list of new impurities, Indian Pharmacopoeial Reference standards, Details

The IP Reference Substances, abbreviated to IPRS are the official standards issued by the Indian Pharmacopoeia Commission (IPC).

Biological Reference Substances are standardized against the International Standards and Reference Preparations established by the World Health Organization (WHO). The potency of these preparations is expressed in International Units.

The list of 7 new Indian Pharmacopoeial Reference Standards includes Amphotericin B, L-Histidine, L-Isoleucine, L-Phenylalanine, L-Leucine, Luliconazole, and Citicoline sodium.

In addition to this, 23 new impurities have been added, which include Citicoline Impurity B, 3-Piperidylpropiophenone HCl, Betaxolol Impurity A, Bezafibrate Impurity A, Bisacodyl Impurity E, Carbimazole Impurity A, Clobetasol Impurity J, Desoxycortone Acetate Impurity (Betamethasone-17-Valerate), Dipivefrine Impurity B, 3-Ketofusidic Acid, Homatropin Hydrobromide Impurity C, Homatropin Impurity B, Leflunomide Impurity C, Levodropropizine Impurity B, Meloxicam Impurity A, Methotrexate Impurity C, Paroxetine Impurity A, Benzyl Penicillin Potassium, Repaglinide Impurity A, Rivastigmine related compound A, Simvastatin Impurity B, Thiamine Impurity C, Tolbutamide Impurity A.

The impurities in pharmaceuticals are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs) or develop during formulation or upon aging of both API and formulation. The presence of these unwanted chemicals even in trace amount may influence the efficacy and safety of pharmaceutical product.

To view the official list, click the link below: