Russian Pharmacopoeia Reference Standards
Distribution of Pharmacopoeial Reference Standards, and Certification of Secondary Reference Standards
In accordance with the Order of the Ministry of Health of the Russian Federation No. 202 ‘On the Metrology Service of the Ministry of Health of the Russian Federation in the Area of Medicinal Products’ of 20 March 2020, the FSBI ‘SCEEMP’ is delegated authority to perform functions of the Metrology Service of the Ministry of Health of Russia in the area of medicinal product regulation.
As authorised by the above Order, the FSBI ‘SCEEMP” carries out:
- certification of pharmacopoeial reference standards used in medicinal product quality control;
- maintenance of the Register of Pharmacopoeial Reference Standards;
- certification of secondary (in-house) reference standards to be used in release testing.
Certified reference standards, which are included in the Register, are available for sale.
The Register of Pharmacopoeial Reference Standards includes:
Chemical Pharmacopoeial Reference Standards;
Biological Pharmacopoeial Reference Standards;
Pharmacopoeial Reference Standards of Natural Origin;
Pharmacopoeial Reference Standards for Identification.
For information on the available pharmacopoeial reference standards distributed by the FSBI ‘SCEEMP’ please visit:
Chemical Pharmacopoeial Reference Standards;
Biological Pharmacopoeial Reference Standards;
Pharmacopoeial Reference Standards of Natural Origin;
Pharmacopoeial Reference Standards for Identification.
Pharmacopoeial reference standards may be ordered via the “R&D Customer Account”.
The FSBI ‘SCEEMP’ carries out certification of secondary (in-house) reference standards using the provided candidate material for which the primary reference standard is available. The certification is performed based on agreements with the material providers.
For consultation on the available services please address fso@expmed.ru