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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.  

Order here for IP Reference Substances

List of impurities

For a list of impurities, click the below link:

Rate-list-of-Impurities

IPC-11-11-2021-List-of-23-New-Impurities

List-of-145-Impurities-Dec-2019

List of Reference Standards

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

IPC-11-11-2021-List-of-7-New-IP-Reference-standards

List-of-594-Reference-Substances-Dec-2019

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

List-of-Phtopharmaceutical-Reference-Substances-available-at-IPC-Ghaziabad

Important Notifications / Notices / Circulars by IPC

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

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

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

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

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

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-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

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

Guidance documents by IPC

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 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:

Indian-Pharmacopoeia-2022-salient-features

Click for news / articles on IPC

National Formulary of India (NFI)

The National Formulary of India is essentially meant for the guidance of the members of the medical profession; medical students, nurses and pharmacists working in hospitals and in sales establishments.

In the preparation of this Formulary, the expert opinion of medical practitioners, teachers in medicine, nurses, pharmacists and Pharmaceutical manufacturers has been obtained.

The selection of drugs for inclusion in the National Formulary has been made taking into consideration the relative advantages and disadvantages of the various drugs used, the extent of their use in current medical practice and their availability in the country.

Thus the National Formulary of India represents a broad consensus of medical opinion in respect of drugs and their formulations and provides the physician with carefully selected therapeutic agents of proved effectiveness which form the basis of national drug therapy.

4th Edition of National Formulary of India has been published in 2011 by the IPC after a gap of more than 3 decades.

The National Formulary of India would prove to be the authoritative guide to prescribing, dispensing and administering medicines for all healthcare professionals.

It will be useful for framing national drug policies in the country. Ministry of Health and Family Welfare, Govt. of India vides its notifications F. No. X. 11035/2/06-DFQC, dated 8th May 2008 assigned this mandatory responsibility to the Indian Pharmacopoeia Commission, Ghaziabad to publish NFI on regular basis.

National Formulary of India (NFI) 2011

To download National Formulary of India (NFI) 2011, click below link

National Formulary of India (NFI) 2011

National-Formulary-of-India-NFI-2011

History of National Formulary of India (NFI):

The IPC with its mission to be one of the leading scientific institutions under the central government puts stress on keeping transparency, accountability and punctuality and the publication of the NFI.

The National Formulary of India editions are as follows:-

1.National Formulary of India 1960 –The First Edition of NFI2.National Formulary of India 1966 –The Second Edition of NFI3.National Formulary of India 1979 –The Third Edition of NFI4.National Formulary of India 2011 – The Fourth Edition of NFI (With CD)5.National Formulary of India 2016 – The Fifth Edition of NFI6.National Formulary of India 2021 – The Sixth Edition of NFI  (current edition)

Click for Notifications / Notices / Circulars by IPC

Contents List for NFI 2016

Contents-List-for-NFI-2016

Salient features of NFI 2016

Salient-features-of-NFI-2016

Salient features of NFI 2021

Salient-features-of-NFI-2021

Online purchase: procedure

Books: IP and NFI

Rates-and-Procedure-to-purchase-of-different-volumes-of-IP-and-NFI

Click here to purchase Books: IP & NFI

IP Reference Substances

Click here to purchase IP Reference Substances

Impurity Standards

Click here to purchase Impurity Standards

Click for other Notifications / Notices / Circulars by IPC

Click for more news and articles on IPC
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