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 the 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.
For List of 145 Impurities Dec 2019, click below link:
For List of 594-Reference-Substances Dec 2019, click below link: