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API synthesis localization

API synthesis localization possibilities of Polisintez – POLYSAN’s subsidiary company (Belgorod, Russia)

Polisintez is mainly focused on production of low-and medium-tonnage APIs and relative intermediate products. The company operates under the production license (chemical synthesis substances and substances derived from chemical raw materials) No.00130-LS as of March 15, 2018 issued by the Ministry of Industry and Trade of the Russian Federation.

The statement issued by the Ministry of Industry and Trade of the Russian Federation substantiates compliance of Polisintez Ltd. with GMP requirements (No.GMP-0057-000264/18 as of May 31, 2018) Other licenses of Polisintez:

- activities related to circulation of drug precursors and psychotropic substances listed in Table I of Register IV, in accordance with the Federal Law “Drugs and psychotropic substances”; - operation of fire-hazardous and chemically-hazardous production facilities of I, II, III hazard classes;
- activities related to usage of infectious agents (infective microorganisms of 3-4 pathogenic risk group).

Warehouses

Raw material and finished product warehouses (1250 m²) are equipped with semi-industrial air conditioning units, air-dryers, automatic climate control, air heating, quarantine area, finished product acceptance room, pre-boxes, box and filter-ventilation stationary module for finished product sampling, defective finished products storage room. Maintained temperature is not higher than 25 ℃, relative humidity doesn’t exceed 65%.

Process areas are designed to establish and safely maintain process flows involving highly inflammable liquids (solvents).
Presently, the plant is focused on crystalline substances (powders) production, thus, the process areas are fit up with the relative equipment.

Presently, the process flows are designed for the substances as follows:

- N-Methylglucamine, production capacity 7900 kg/month;
- Succinic acid, production capacity 6200 kg/month;
- Acridonacetic acid, production capacity 2700 kg/month;
- Integrated process flow for low-tonnage substances, average capacity – 1500-3000 kg/month.

Production area lab

- sampling and quality control of semi-products, waste water and process wastes;
- validation, analytical methods verification, lab equipment qualification;
- intermediate products stability study.

Analytical and microbiological laboratory of QC department

- analytical and microbiological tests to verify correspondence of raw materials, materials and finished product to the specifications;
- validation, test methods verification, laboratory lab equipment qualification;
- process validation;
- raw materials, materials and finished products storage conditions monitoring;
- storage of retain samples of finished products, raw material/material control samples in proper conditions;
- microbiological monitoring of process environment;
- finished product stability study;
- random control of finished products by supervising authorities of the Russian Federation.

Chemical and physical-chemical analysis by the onsite lab

Titrimetry, ionometry, conductometry, UV and visible spectrophotometry, IR spectroscopy, calorimetry, polarimetry, high performance liquid chromatography, gas chromatography, thin-layer chromatography, bulk density, loss on ignition, loss on drying, melting temperature, accelerated stability study and stability study in normal conditions. Microbiological analysis: microbiological purity, bacterial endotoxins.

 
 
Salova str., Bld 72, Unit 2, Litt. A, Saint Petersburg,Russian Federation, 192102 Tel: + 7-812-710-82-25, Fax: +7-812- 764-62-84

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