IPC adds 8 New Impurities Standards & 10 New Indian Pharmacopoeia Reference Substances
Indian Pharmacopoeia Commission (IPC) Ghaziabad has now added 8 New Impurities Standard and 10 New Indian Pharmacopoeia Reference Substances (IPRS). Now a total of 49 impurities and 456 IPRS are available at IPC for stakeholders.
The move is to strengthen availability of impurity standards and reference substances. The new list of impurity standards covered are Tolnaftate impurity A, Mesalazine impurity E, Lansoprazole sulphide, Hydrazine Sulphate, Cyclizine impurity A, Potassium sodium tartrate, Hexacosane and Phthalazine.
In the case of Indian Pharmacopoeia Reference Substances, the 10 new inclusions are Benazepril Hydrochloride, Midazolam, Ipratropium Bromide, Ethacrynic Acid, Brinzolamide, Pimozide, Zolmitriptan, Erlotinib Hydrochloride, Progesterone and Vanillin.
According to Dr. P L Sahu, principal scientific officer, Indian Pharmacopeia Commission, impurity standards are very essential for related substance analysis. Further, it is also important for ensuring the product quality.
Impurity standards are used to perform the system suitability, qualitative and quantitative parameters for compliance to Indian Pharmacopoeia monograph.
The Commission has created a set of standards for drugs in the country. Its basic function is to update regularly the standards of drugs commonly required for treatment of diseases prevailing in this region. It publishes official documents for improving quality of medicines by adding new and updating existing monographs in the form of Indian Pharmacopoeia (IP). It further promotes rational use of generic medicines by publishing National Formulary of India, stated the IPC officials.
Lot number for 15 IPRS has been changed. These are Proguanil Hydrochloride, Probenecid, Divalproex Sodium, Chlordiazepoxide, Chloroquine Sulphate, Sulphadoxine, Amitriptyline Hydrochloride, Fluoxetine Hydrochloride, Glibenclamide, Ramipril, Tinidazole, Nandrolone Phenylpropionate, Carbamazepine, Fexofenadine Hydrochloride and Nevirapine.
According to the Commission, certain monographs require the use of a chemical reference substance or a biological reference preparation or a reference spectrum. These are authentic specimens chosen and verified on the basis of their suitability for intended use as prescribed in the Pharmacopoeia and are not necessarily suitable in other circumstances. IP Reference Substances are the official standards to be used in cases of arbitration.
“Initially the Commission has identified 400 IPRS and it was a challenging task to further strengthen this. However, IPC could add 10 of these new IP reference substances. Now we are more focused on ensuring the availability of the impurity standards and therefore we could release the list of 49 impurities in the shortest possible time,” stated Dr Sahu.
