New Delhi: Through a recent notice, the Indian Pharmacopoeia Commission (IPC) has added 7 new Indian Pharmacopoeia reference standards and 23 new impurities.

IP reference substances, abbreviated as IPRS, are the official standards issued by the Indian Pharmacopoeia Commission (IPC).

Biological reference materials are standardized according to 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 Pharmacopoeia reference standards includes amphotericin B, L-histidine, L-isoleucine, L-phenylalanine, L-leucine, luliconazole and citicoline sodium .

In addition, 23 new impurities have been added, including citicoline impurity B, 3-piperidinylbenzene HCl, betaolol impurity A, bezafibrate impurity A, bisacodyl impurity E, carbohydrate Bimazole impurity A, clobetasol impurity J, Desoxycortone Acetate (valeric acid), dipivulin impurity B, 3-ketofusidic acid, hydromatropine hydrobromide impurity C, Homatropin impurity B, Flunomide impurity C, levpromazine impurity B, meloxicam impurity A, methotrexate impurity C, paroxetine impurity A, amphetamine benzoate impurity A, rivastigmine related compound A, simvastatin impurity B, Thiamine impurity C, tolbutamide impurity A.

Impurities in drugs are harmful chemicals that remain in the active pharmaceutical ingredient (API) or are generated during the formulation process or when the API and formulation age. Even the presence of trace amounts of these unwanted chemicals may affect the efficacy and safety of medicines.

To view the official list, please click on the following link:

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