Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on November 26, 2024 by The Health Master
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
2024
IPC Alert dt 28-08-2024 Metronidazole Adverse Drug Reactions
IPC Alert Metronidazole Adverse Drug Reactions
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 Draft Guidelines dt 01-03-2024 for inclusion of Disinfectant and Antiseptics in IP
IPC Draft Guidelines dt 01-03-2024 for inclusion of Disinfectant and Antiseptics in IP
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 Alert: About adverse reactions to Meftal Painkiller
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
For other Notifications / Notices / Circulars by IPC, Click here
Also read: Safety alerts issued by IPC
Indian Pharmacopoeia (IP) Addendum 2024
Indian Pharmacopoeia Addendum 2024 salient features, click the link below:
Indian Pharmacopoeia Addendum 2024 Salient Features
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
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Indian Pharmacopoeia Commission (IPC)
Latest Circulars: (IPC) Indian Pharmacopoeia Commission
Latest Notifications regarding Pharmaceuticals
Latest on National Formulary of India (NFI)
Latest IPC Alert – Indian Pharmacopoeia Commission
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