The Indian Pharmacopoeia Commission (IPC) has added ten new impurity reference substances to the Indian Pharmacopoeia (IP) 2022 for ensuring the quality, safety, and efficacy of pharmaceutical products.

With this, now a total of 365 impurities are available at IPC for stakeholders.

The newly added impurity standards are:

- 2-(4-butyl phenyl)-propionic acid,

- Allopurinol impurity B,

- Methyltestosterone,

- Naproxen impurity L,

- Olopatadine impurity B,

- Ondansetron impurity A,

- Phenytoin impurity D,

- Rabeprazole sulphone,

- Risperidone-cis-N-oxide,

- Tropicamide impurity A.

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The commission stated that impurity standards are very essential for related substance analysis.

Further, it is also important for ensuring product quality. Impurity standards are used to perform the system suitability, qualitative and quantitative parameters for compliance with the Indian Pharmacopoeia monograph, it added.

The IPC launched 15 new impurity reference substances during its 50th Scientific Body meeting on September 28, 2022.

These include:

- Sitagliptin,

- Amiodarone impurity A,

- Amiodarone impurity B,

- Amlodipine impurity D,

- Cefradine,

- Cephradine,

- Diazepam impurity B,

- Econazole nitrate,

- Fenbendazole impurity B,

- Fluconazole impurity C,

- Indapamide impurity A,

- Norfloxacin impurity E,

- Quetiapine impurity A,

- Teneligliptin impurity C,

- 6-chloro-3-hydroxyamide (Chlor homolog impurity).

In August this year, the Commission also added seven new impurity reference substances to Indian Pharmacopoeia 2022.

The list of impurity 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.

The move is to strengthen the availability of impurity standards. The IPC has established a set of standards for medical products in the country.

Its basic function is to regularly update the standards of drugs commonly required for the treatment of diseases prevailing in the country.

It publishes Indian Pharmacopoeia for improving the quality of medicines by adding new and updating existing monographs.

It further promotes the rational use of generic medicines by publishing the National Formulary of India.

On July 1, 2022, the Union health and family welfare ministry released the 9th edition of IP 2022 containing:

- 92 new monographs for drugs,

- 12 new general chapters,

- 1,245 monographs for formulations,

- 930 monographs for active pharmaceutical ingredients (APIs) as well as dissolution specifications for all prolonged-release formulations.

To date, there are no such specifications for prolonged-release formulations. It will impact public health in the long term in a big way.

The IPC is also a participant in the Pharmacopoeial Discussion Group (PDG) pilot for global expansion.

Currently, the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP) are members of PDG.

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