Indian Pharmacopoeia Commission (IPC)

Last Updated on July 30, 2023 by The Health Master

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Download the latest from the Indian Pharmacopoeia Commission (IPC)

IP Reference Substances (IPRS) & Impurity Standards

Reference Substances: 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 Pharmacopoeia and are not necessarily suitable in other circumstances. 

IP Reference Substances, abbreviated to IPRS (and referred to as RS in the individual monographs) are issued by the Indian Pharmacopoeia Commission (IPC).

They 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

Biological Reference Substances, also abbreviated to IPRS and Standard Preparations of antibiotics are issued by agencies authorised 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.  

List of impurities

For a list of impurities, click the below link:

List of Reference Standards

For the List of Reference Standards, click the below link:

List of Phytopharmaceutical Reference Substances

List of Phytopharmaceutical Reference Substances available at IPC Ghaziabad, click the below link:

List of IPRS available at IPC, Ghaziabad


Important Notifications / Notices / Circulars by IPC

2023

IPC dt 02-02-2023 Outcome of Pharmacovigilance Programme of India (PvPI) for taking appropriate regulatory actions

IPC dt 31-01-2023 List of suspected drugs which are associated with the Adverse Drug Reaction

IPC dt 13-01-2023 Amendment list 002 to IP-2022

2022

IPC dt 13-12-2022 Corrigendum to amendment list 01 of IP 2022

IPC dt 28-11-2022 Amendment List 01 to IP 2022

IPC Notice dt 27-10-2022 Clarifies on uniformity of dosage units & impurities in IP 2022

IPC dt 26-10-2022 Draft Amendments for comments IP 2022

2021

IPC dt 30-12-2021 – Amendment List-09 to IP-2018

IPC dt 16-09-2021 – Guidance document on Calibration of Gas Chromatograph

IPC-dt-16-09-2021-Guidance-document-on-Calibration-of-Gas-Chromatograph

IPC dt 16-09-2021 – Guidance document on Calibration of HPLC

IPC-dt-16-09-2021-Guidance-document-on-Calibration-of-HPLC

IPC dt 16-09-2021 – Guidance document on Compliance with Indian Pharmacopoeia Standards

IPC-dt-16-09-2021-Guidance-document-on-Compliance-with-Indian-Pharmacopoeia-Standards

IPC dt 16-09-2021 – Guidance document on Good Documentation Practices

IPC-dt-16-09-2021-Guidance-document-on-Good-Documentation-Practices

IPC dt 16-09-2021 – Guidance document on Legal Status of Indian Pharmacopoeia

IPC-dt-16-09-2021-Guidance-document-on-Legal-Status-of-Indian-Pharmacopoeia

IPC dt 16-09-2021 – Guidance document on Process for Development of Indian Pharmacopoeia Monographs

IPC-dt-16-09-2021-Guidance-document-on-Process-for-Development-of-Indian-Pharmacopoeia-Monographs

IPC dt 16-09-2021 – Guidance document on Quality Management System in Testing Laboratory

IPC-dt-16-09-2021-Guidance-document-on-Quality-Management-System-in-Testing-Laboratory

IPC dt 16-09-2021 – Guidance document on Validation of Analytical Methods

IPC-dt-16-09-2021-Guidance-document-on-Validation-of-Analytical-Methods

IPC Notice dt 26-07-2021 – IP Addendum 2021 shall be effective from 31-12-2021

IPC dt 24-06-21 – Revised Draft General Chapter on Approach to Alternative Microbiological Methods

IPC 10-03-2021 – Omission of Monographs of ‘Lorcaserin Hydrochloride Hemihydrate’ and Lorcaserin Tablets’ from the Indian Pharmacopoeia

IPC dt 26-02-2021 – Clarification on Alternative Methods in the Indian Pharmacopoeia

IPC dt 25-02-2021 – Amendment List-08 to IP-2018

IPC 19-02-2021 – Release of Guidance Document for Drafting and Formatting of Monographs for Indian Pharmacopoeia

IPC dt 12-01-2021 – Draft of General Notices on Phytopharmaceutical Drugs

Guidance documents by IPC

IPC dt 08-07-2022 Guidance document on –General Calculations in Indian Pharmacopoeia

IPC Dt 01-06-2022 Guidance document on – Indian Pharmacopoeia Reference Substances

IPC dt 16-09-2021 – Guidance document on Calibration of Gas Chromatograph

IPC dt 16-09-2021 – Guidance document on Calibration of HPLC

IPC dt 16-09-2021 – Guidance document on Compliance with Indian Pharmacopoeia Standards

IPC dt 16-09-2021 – Guidance document on Good Documentation Practices

IPC dt 16-09-2021 – Guidance document on Legal Status of Indian Pharmacopoeia

IPC dt 16-09-2021 – Guidance document on Process for Development of Indian Pharmacopoeia Monographs

IPC dt 16-09-2021 – Guidance document on Quality Management System in Testing Laboratory

IPC dt 16-09-2021 – Guidance document on Validation of Analytical Methods

IPC Alerts

Click the below links to read full details:

IPC flags drug safety alert against Minoxidil

IPC alert: About Norfloxacin induced skin hyperpigmentation

IPC alerts about Cefoperazone induced coagulopathy

IPC flags safety alert against immunosuppressive drug Tacrolimus

IPC flags safety alert against Blood Pressure drug, Losartan

IPC flags safety alert against most common Drug Ibuprofen – NSAID

IPC flags safety alert against Covid-19 drug Remdesivir

IPC flags safety alert against NSAID Diclofenac

IPC flags safety alert against Dimethyl Fumarate & Cefazolin

Safety alert against Hepatitis C drug Sofosbuvir: IPC

IPC flags Safety Alerts against these drugs interaction

IPC sounds safety alerts against these Medicines


For other Notifications / Notices / Circulars by IPC, Click here


Also read: Safety alerts issued by IPC

National Indian Pharmacopoeia (IP) 2022

Indian Pharmacopoeia 2022 salient features, click the link below:


Online purchase: procedure

Books: IP and NFI

IP Reference Substances

Impurity Standards





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