Why do we need reference standards?

Why do we need reference standards?

Reference standards are used to determine quantitative data (such as assay and impurity), qualitative data (such as identification test), and calibration (such as melting point standard). Therefore, the quality and purity of the reference standards are crucial to achieve scientifically valid results.

What is difference between EMA and EDQM?

The European Medicines Agency (EMA) works with the European Directorate for the Quality of Medicines and HealthCare (EDQM), a directorate of the Council of Europe. The EDQM traces its origins and statutes to a European treaty promoting the elaboration of a common pharmacopoeia in Europe.

What is EDQM certificate?

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, Protocol).

What is reference standard characterization?

Reference Standard Characterization studies are used to determine the physiochemical profile of a drug substance or product in order to establish a standard for subsequent stages of testing. This testing is essential for characterising and analysing both original biologics and biosimilars.

Are there expiration dates on USP Reference standards?

With the exception of USP Prednisone Tablets RS catalog #1559505, current lots of USP Reference Standards do not have valid use dates (expiration dates). As long as a lot is listed as being the “current lot,” it is valid and suitable for use. Once a current lot is depleted, it becomes the “previous lot.”

How can I find out the expiry date of an EDQM reference?

The user must ensure that the EDQM Reference Standard is valid at the time of use by checking the Batch Validity Statement (BVS) available from the Ph. Eur. Reference Standards Database. It is recommended to purchase only a sufficient amount for immediate requirements and use.

Where can I find the European Pharmacopoeia reference standards?

The catalogue lists all the reference standards officially valid for the uses prescribed in the European Pharmacopoeia monographs. It is updated daily. Download the PDF format of our catalogue here. To access the most updated information about our reference standards we advise to use the online database.

When is a USP Reference Standard considered an official method?

A USP Reference Standard, where explicitly mentioned in an official USP compendial monograph, is considered to be part of the official method. In the event of a dispute, it is the USP monograph with its associated USP Reference Standard (s) which determines compliance.