Last Updated on December 30, 2023 by The Health Master
Download the list of New Impurities & New IP Reference standards: The Indian Pharmacopoeia Commission (IPC) has added 23 new impurities standards and 7 new Indian Pharmacopoeial Reference standards.
The list of new 23 impurities standards includes:
- 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 list of new Indian Pharmacopoeial Reference standards includes:
- Amphotericin B,
- L-Histidine,
- L-Isoleucine,
- L-Phenylalanine,
- L-Leucine,
- Luliconazole
- Citicoline sodium.
Impurity standards are used to perform the system suitability, qualitative and quantitative parameters for compliance to Indian Pharmacopoeia monograph.
The commission stated that 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, abbreviated to IPRS are the official standards issued by the IPC. They are the official standards to be used in cases of arbitration.
The vision of IPC is to promote the highest standards of drugs for use in human and animals within practical limits of the technologies available for manufacture and analysis
IPC is an autonomous institution of the ministry of health and family welfare, Government of India.
IPC is created to set standards of 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.
The mandate of the commission is to perform, inter-alia, functions such as revision and publication of the Indian Pharmacopoeia and National Formulary of India on a regular basis besides providing IP reference substances and training to the stakeholders on pharmacopoeial issues.
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