IPC adds 23 new impurities standards and 7 Indian Pharmacopoeial Reference standards

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The Indian Pharmacopoeia Commission (IPC) has added 23 new impurity standards and 7 new Indian Pharmacopoeial Reference standards to the Indian Pharmacopoeia.

The new impurity standards include the following: Citicoline Impurity B, 3-Piperidylpropiophenone  HCl, Betaxolol Impurity A, Bezafibrate Impurity A, Bisacodyl Impurity E, Carbimazole Impurity A, Clobetasol Impurity J, Desoxycortone Acetate Impurity, 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 new Indian Pharmacopoeial Reference standards list includes Amphotericin B, L-Histidine, L-Isoleucine, L-Phenylalanine, L-Leucine, Luliconazole, and Citicoline sodium.

To comply with the Indian Pharmacopoeia monograph, impurity standards are used to determine system appropriateness and qualitative and quantitative criteria.

According to the commission, the use of a chemical reference substance, a biological reference preparation, or a reference spectrum is required in some monographs. These are genuine specimens that have been chosen and validated for their fitness for the intended application as indicated in the pharmacopoeia, and are not necessarily useful in other situations.

The IP reference substances, abbreviated as IPRS, are the IPC’s official standards. They are the official norms that must be followed in arbitration cases.

IPC’s mission is to promote the highest quality of pharmaceuticals for human and animal use within the practical boundaries of current manufacturing and analysis technologies.

The IPC is an independent body under the Ministry of Health and Family Welfare of the Government of India. The IPC was established to establish drug standards in the country. Its primary duty is to keep track of the drug standards that are routinely used to treat ailments in this area. The commission’s mandate includes, among other things, regular modification and publishing of the Indian Pharmacopoeia and National Formulary of India, as well as provision of IP reference compounds and training to stakeholders on pharmacopoeial concerns.

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