OUR TESTING CENTER HAS BEEN KNOWN IN THE MARKET FOR THE PROVISION OF PRODUCT QUALITY AND SAFETY CONTROL SINCE 1999.

our Biotechnology is accredited by the Federal Accreditation Service (Accreditation Certificate No. RA.RU.21ФМ04) for carrying out work on testing products in accordance with the scope of accreditation.


The scope of accreditation includes  Russian finished medicines registration certificate，active pharmaceutical substances, excipients, dietary supplements (BAA) for food, raw materials for the production of medicines and BAB, water (drinking, natural, for the preparation of beverages and food products, purified) and etc.

The main goal of the company is the high quality of work performed to conduct product testing, maximum satisfaction of customer requirements, competitiveness of the services provided.

To achieve this goal, the Testing Center has implemented a quality management system, which is a management tool for administrative, technical and human resources, and aimed at eliminating and preventing inconsistencies the quality of services provided by the quality policy , consumer requirements and the relevant legal and other mandatory requirements.

For testing incoming products, chemical, physicochemical, microbiological and biological research methods are used.

Chemical Analytical Laboratory
Chemical Analytical Laboratory
The chemical analytical laboratory as part of the physicochemical control (GFKhK) and control assurance (GOK) groups is equipped with GLP requirements, has a large fleet of modern equipment that undergoes annual maintenance, metrological control and qualification (OQ, PQ).

The Chemical Analytical Laboratory has, and maintains, a License to carry out activities related to the trafficking of narcotic drug precursors.

Highly qualified laboratory personnel are systematically trained in various training centers.

The laboratory performs the following types of tests:
Liquid chromatography, Ultra-HPLC, size exclusion HPLC, derivatization HPLC (amino acid analysis) equipped with UV, diode, and refractometric detectors.
Gas chromatography equipped with PID detectors and Head-space in various designs, both a syringe for vapor-phase sampling and as a closed system (loop).
Spectroscopic analysis methods (UV / VID spectrophotometry, IR / NIR spectrometry, Atomic absorption spectrometry with electrothermal atomization).
Titrimetric methods of analysis, including Non-aqueous titration using acetic anhydride, Kjeldahl method (back titration) for the determination of nitrogen in organic compounds.
Development of methodologies for ND / FSP projects for drug registration, writing of ND / FSP projects.
Development and validation of methods, followed by analytical transfer of methods to production.
Tests of comparative dissolution kinetics (TSCR) for registration of drugs.
Studying the stability of drug quality indicators, including stress tests.
Microbiological - laboratory
Microbiological - laboratory
The microbiological laboratory has, and maintains, a license to work with microorganisms.

The microbiological laboratory has a separate room, is built and equipped with the latest pharmaceutical technologies in accordance with the requirements of the international GLP standard.


The laboratory conducts the following types of tests:
Microbiological purity
Sterility (direct seeding method, membrane filtration method)
Bacterial endotoxins LAL test (qualitative and quantitative analysis)
Control of growth properties of culture media
Determination of antimicrobial action
Quantification of antibiotics by agar diffusion
Quantification of live microorganisms (CFU / g)
Quantitative determination of vitamins by the microbiological method
Determination of the effectiveness of antimicrobial preservatives
Microbiological monitoring of the working environment (air, surfaces, clothing)
Verification of compliance with the suitability conditions of microbiological methods
Validation of microbiological methods
Electronic Laboratory Information System "ELLIS"
Electronic Laboratory Information System "ELLIS"
The ELLIS laboratory information system has been installed in the CoAL Pharmaceuticals laboratory, which allows you to automate the work of departments within the laboratory, track the movement of samples received for control, generate test reports with a quality report, and generate retest protocols for investigating cases of non-compliance. The entire material and technical base is compiled in ELLIS, which allows electronic recording of each piece of equipment, standard sample and chemical reagent, tracking the quantities and expiration dates of CO and chemical reagents, the timing of metrological control of SI and IO.

Quality control quality control
Pre-registration control of drugs and revision of ND / FSP projects Pre-registration control of drugs and revision of ND / FSP projects
Development and validation of techniques Development and validation of techniques
Analytical transfer of techniques Analytical transfer of techniques
Carrying out the test of comparative dissolution kinetics (TSCR) Carrying out the test of comparative dissolution kinetics (TSCR)
Study of drug stability Study of drug stability
Microbiological monitoring of the working environment Microbiological monitoring of the working environment
Determination of antimicrobial action Determination of antimicrobial action
Control of growth properties of culture media Control of growth properties of culture media
Validation of cleaning equipment and manufacturing process Validation of cleaning equipment and manufacturing process
Test
Description Description
Packaging and labeling Packaging and labeling
Osmolarity (osmolality, isotonicity) Osmolarity (osmolality, isotonicity)
Average mass and mass uniformity Average mass and mass uniformity
Mechanical inclusions Mechanical inclusions
Authenticity Authenticity
Loss in mass during drying Loss in mass during drying
Melting point melting point
Moisture (water) Moisture (water)
Tests for purity and admissible limits of impurities Tests for purity and admissible limits of impurities
Specific rotation specific rotation
Specific absorption rate by the SF method Specific absorption rate by the SF method
Heavy Metals Heavy Metals
Refractive index refractive index
Sulphated Ash Sulphated Ash
Viscosity viscosity
Quantification quantification
Dosing uniformity Dosing uniformity
pH, alkalinity, acidity pH, alkalinity, acidity
Foreign impurities Foreign impurities
Density Density
Residual Organic Solvents Residual Organic Solvents
Dissolution Dissolution
Disintegration (in one or two environments) Disintegration (in one or two environments)
Hardness, abrasion resistance of a tablet Hardness, abrasion resistance of a tablet
Particle Size (Microscopy) Particle Size (Microscopy)
Pellet size (sieve method) Pellet size (sieve method)
Definition of talc (aerosil) Definition of talc (aerosil)
Determination of sulfur by GF (evaporation, titration) Determination of sulfur by GF (evaporation, titration)
Determination of alcohol by GF (distillation method) Determination of alcohol by GF (distillation method)
Definition of the dry residue of ZhLS
Determination of acid number, saponification number, iodine number, ether number Determination of acid number, saponification number, iodine number, ether number
Homogeneity suppository, ointments Homogeneity suppository, ointments
Determination of nitrogen according to Kjeldahl Definition of nitrogen according to Kjeldahl
Tightness of the blisters Tightness of the blisters
Suppository Complete Deformation Time Suppository Complete Deformation Time
Radiological control of plant materials Radiological control of plant materials
Biological Test Methods Biological Test Methods
Microbiological Test Methods Microbiological Test Methods
Microbiological monitoring of the working environment Microbiological monitoring of the working environment
                                  
微信扫一扫联系我们                                       公众号 关注我