Last Updated on October 7, 2024 by The Health Master
With an aim to ensure the quality, safety, and efficacy of pharmaceutical products, the Indian Pharmacopoeia Commission (IPC) has added a new set of Indian Pharmacopoeial Reference Standards (IPRS) and twenty new impurity reference substances to the Indian Pharmacopoeia (IP) 2022.
The newly launched IPRS is trazodone hydrochloride. With this, the number of IPRS in IP 2022 has reached 661.
Besides an IPRS, IPC has also launched twenty new impurity reference substances, viz.:
- Benzothiadiazine-related compound A,
- Bezafibrate impurity B,
- Clindamycin impurity A,
- Clindamycin impurity E (clindamycin hydrochloride),
- Clopidogrel impurity A,
- Dexamethasone sodium phosphate impurity A,
- Fluoxetine impurity C,
- Guanine,
- Levetiracetam impurity A,
- Levetiracetam impurity D,
- Mefenamic acid impurity C,
- Mefenamic acid impurity D,
- Methotrexate impurity B,
- Metoprolol succinate impurity B,
- Rabeprazole sulphide,
- Tamsulosin racemate,
- Terbinafine-related compound A,
- Terbinafine-related compound C,
- Terbinafine-related compound D.
The newly launched impurities have brought the number of impurity reference substances in IP 2022 to 385.
Speaking about the importance of IPRS and impurities, IPC 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 are the official standards to be used in cases of arbitration.
Secondary Standards (Working Standards) may be used for routine analysis, provided they are standardized at regular intervals against the Reference Substances, it said.
On the other hand, biological reference substances, also abbreviated to IPRS, and standard preparations of antibiotics are issued by agencies authorized by the IPC.
They 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 commission added.
Buying Indian Pharmacopoeial Reference Standard is a social and legal responsibility of the industry, it stated.
IP is recognized as the official book of standards for the drugs being manufactured and/or marketed in India.
IP contains a collection of authoritative procedures of analysis and specifications of drugs for their identity, purity and strength.
The standards of the IP are authoritative in nature and are enforced by the regulatory authorities for ensuring the quality of drugs in India.
During quality assurance and at the time of dispute in the court of law the IP standards are legally acceptable.
In August this year, IPC added five new IPRS and seven new impurity reference substances to IP 2022.
The newly launched IPRS included:
- Disopyramide phosphate,
- Dolutegravir sodium,
- Estradiol hemihydrate,
- Propofol,
- Tenofovir alafenamide fumarate.
While the list of newly launched impurities:
- Reference substances contained clobazam impurity A,
- Levocetirizine amide,
- Lumefantrine-related compound A,
- Quetiapine impurity I,
- Tamoxifen citrate impurity standard,
- Tinidazole impurity B,
- Trimethoprim impurity B.
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