Seven new types of state standard samples manufactured by FSUE Endopharm have passed metrological expertise and been approved by Orders of Federal Agency for Technical Regulation and Metrology (Rosstandart) (Order No. 1200 dated May 17, 2022 and Order No. 1248 dated May 24, 2022). SS for the lidocaine hydrochloride monohydrate (MEZ-038) composition of SSS 11919-2022, SS for the pregabalin composition (MEZ-032) of SS 11920-2022, SS for the meldonium dihydrate composition (MEZ-035) SSS 11923-2022, SS for the metoclopramide hydrochloride monohydrate composition (MEZ- 039) of SSS 11924-2022, SS for the meloxicam composition (MEZ-040) of SSS 11925-2022, SS for the metoprolol tartrate composition (MEZ-042) of SSS 11926-2022, SS for the metformin hydrochloride composition (MEZ-043) of SSS 11927-2022.
Now manufacturers of medicinal products which include lidocaine, pregabalin, meldonium, metoclopramide, meloxicam, metoprolol and metformin have new domestic state standard samples (SSSs) required for quality control of medicinal products in demand by the Russian healthcare system that are used in neurology, ophthalmology , dentistry, surgery, otolaryngological practice, for blockade of peripheral nerves and nerve plexuses in patients with pain syndrome, with neuropathic pain and epilepsy, in the treatment of rheumatoid arthritis and other degenerative joint diseases, in patients with diabetes mellitus, during radiation and chemotherapy, in the treatment of joint diseases, cardiovascular diseases and other areas.
The standard sample is required for the control of the accuracy of measurement results and confirmation of the authenticity of the substance being determined. Its composition and properties are established during certification followed by the sample reception of the status of a national SSS.
The areas of application of standard samples include not only the pharmaceutical industry but also the veterinary industry, forensic medical examination, scientific research and the cosmetic industry.
FSUE Endopharm is a member of State Service for Standard Samples of Composition and Properties of Substances and Materials (SSSS). The company has produced more than fifty standard samples including analytical standard samples, and the portfolio is constantly replenished. 25 of them are used in the manufacture of medicinal products from the Vital and Essential Drugs List. By the end of the current year, the Company plans to increase the range of manufactured SSSs by at least two times.
The up-to-date information on the nomenclature of standard samples produced by FSUE Endopharm is available in the Federal Information Fund for Ensuring the Uniformity of Measurements (FSIS Arshin) at https://fgis.gost.ru/fundmetrology/registry/19 as well as at our website: https://endopharm.ru/product/standartnye-obraztsy/.
Comment type is not specified in the component properties.