SIVILAB®
COMMERCIALIZATION OF MEDICINAL PRODUCTS
SIVILAB® is accredited in the national accreditation system (Federal Accreditation Service) and has the right to test medicinal products for compliance with the requirements of the manufacturer’s normative documents under Commercialization procedure according to the approved scope of accreditation.
Test objects: medicinal products of specific manufacturer, that have been commercialized within one year (one batch of each trade name, taking into account the dosage form and strength).
SIVILAB® provides the quality evaluation of the medicinal products in accordance with the requirements of GOST ISO/IEC 17025–2019 “General Requirements for the Competence of Testing and Calibration Laboratories” and with the Accreditation Criteria (Order of the Ministry of Economic Development of the Russian Federation No. 707 dated October 26, 2020); Federal Law No. 449-ФЗ dated November 28, 2018 “On Amending Individual Legislative Acts of the Russian Federation Concerning the Commercialization of Medicinal Products for Human Use”, in accordance with Article 52.1 of Federal Law No. 61-ФЗ dated April 12, 2010 “On Drug Circulation” as well as in accordance with the requirements of applicable standards and GLP principles (GOST 33044-2014 “Principles of Good Laboratory Practice”). Test protocols for the test objects are prepared in accordance with the rules specified in GOST Р 58793–2020 “Rules for Execution of Test Protocols”.
As a part of Commercialization procedure SIVILAB® carries out analytical tests of the medicinal products using the following methods:
Physical and chemical quality control tests
- High performance liquid chromatography (assay, identification, related substances, uniformity of dosage units)
- Liquid chromatography–mass spectrometry (related substances)
- Gas chromatography (assay, identification, related substances, residual solvents)
- Thin layer chromatography
- Infrared absorption spectrometry (identification)
- UV-Visible Spectrophotometry (assay, identification, related substances)
- Atomic absorption spectrometry
- Polarimetry (optical rotation, specific rotation)
- Refractometry (refractive index)
- Density (using pycnometers, density meter)
- Titration methods
- Solubility (in one medium, in two media) using paddle stirrer, basket
- Disintegration time (in one medium, in two media) for solid dosage forms and suppositories
- Visual method (clarity or color of solution)
- Electrochemical method (water by K. Fisher method)
- Melting point (capillary method)
- Osmolality (cryoscopic)
- Conductimetry (specific conductivity)
- Potentiometry (solution pH)
- Light obscuration particle count test (sub-visible particulate matter) and others.
Microbiological quality control tests
- Microbial limit (plate agar method, membrane filtration method, most probable number method)
- Sterility test (membrane filtration method, direct inoculation method)
Biological quality control tests
- Bacterial endotoxins (gel-clot method, turbidimetric method, chromogenic method)
- Assessment of antimicrobial activity of antibiotics by agar diffusion
Services
- 1Testing for commercialization
- 2Verification of compendial methods
- 3Transfer of analytical procedures
If you have any questions, you can receive a consultation. Please fill in the form below
and send a request.
and send a request.
If you have any questions, you can receive a consultation. Please fill in the form below and send a request.
© 2024 SIVIlab
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Services
Contact Us
121205, Moscow, Skolkovo Technopark, Bolshoy Boulevard,
42, building 1
664048, Irkutsk, Rosa Luxemburg St., 184/1
info@sivilab.ru
42, building 1
664048, Irkutsk, Rosa Luxemburg St., 184/1
- +7 3952 550-330
info@sivilab.ru
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+ 7 (3952) 550-330