Contract Development
A wide range of services
Chromatography and analytical groups perform quality control of medical products, pharmaceutical substances, excipients (among them HPLC and GC methods); develop method analysis of new medical products; validate analytical methods.
Employees of the standardization group prepare registration dossier (including CTD format), develop in-house standards and procedures, and support quality system.
Technology-and-testing laboratory develops composition and technology of new medical products products, validate technological processes, carries out activity on scaling-up.
R&D Laboratory in cooperation with R&D Department perform the following science-research and design-and-experimental activities:
- Development of composition and technology of new medical products and their further launching into manufacture
- Transfer of medical products technology to commercial scale
- Medical products, pharmaceuticals and excipients testing
- Stability testing of medical products and pharmaceutical substances
- Development and validation of method analysis of medical products
- Preparation of registration documents for medical products and pharmaceutical substances
- Research activities focused on new pharmaceutical products development
- Support of registration of medicines and pharmaceutical substances and clinical trial authorization.
 (1).jpg)
R&D Laboratory has experience in pharmaceutical development of the below mentioned pharmaceutical forms:
- Tablets
- Coated tablets
- Dispersible tablets
- Modified release tablets
- Capsules
- Suppositories
- Syrups
- Emulsions
- Powders/granules for suspension/oral liquids
- Oral gels
.png)
.png)
.png)
Execution Timeframes
Quality Assurance
Equipment
In order to accomplish the above mentioned tasks R&D Laboratory applies technological and analytical equipment produced by the leading global manufacturers.
Chromatography and analytical group develops and validate analytical methods for excipients, pharmaceutical forms under development and active pharmaceutical ingredients in compliance with CPMP/ICH/381/95, European Pharmacopoeia and USP.
In order to conduct necessary testing properly. Chromatography group is equipped with up-to-date analytical devices (HPLC, gas-liquid chromatography, dissolution test machines etc.) produced by:
Equipment
HPLC system Shimadzu LC-20 Promince:
equipped with embedded degassing agent, gradient four-channel pump, thermostatic autosampler, column thermostat, photodiode array detector, refractive index detector, light-diffusing detector. Used when tests, regarding Eur. Ph. 2.2.29, USP <621> and other regulatory documents are carried out.feeding unit, electromotor, tablet dust remover.
HPLC system Shimadzu LC2010HT:
equipped with embedded degassing agent, gradient four-channel pump, thermostatic autosampler, column thermostat, spectrophotometric detector. Used when tests, regarding Eur. Ph. 2.2.29, USP <621> and other regulatory documents are carried out.
HPLC system Waters Alliance:
equipped with embedded degassing agent, gradient two-channel pump, autosampler, column thermostat, spectrophotometric detector. Used when tests, regarding Eur. Ph. 2.2.29, USP <621> and other regulatory documents are carried out.
Gas-liquid chromatography Agilent 7820A:
equipped with liquid sample injector, headspace analysis autosampler. Used when tests, regarding Eur. Ph. 2.2.28, USP <621> and other regulatory documents are carried out.
Dissolution system PT DT70
Used when tests, regarding Eur. Ph. 2.9.3, USP <711> and other regulatory documents are carried out.
Spectrofluorometer Fliuorat-02 Panorama
Used when spectrofluorometrical tests, regarding Eur. Ph. 2.9.3, USP <711> and other regulatory documents are carried out.
Polarimeter AP300
Used when tests, regarding Eur. Ph. 2.2.7, USP <781> and other regulatory documents are carried out.
Spectophotometer SPEKS SSP
Used when tests, regarding Eur. Ph. 2.2.25, USP <851> and other regulatory documents are carried out.
ERWEKA Test Machine for fragility/friability testing of solid dosage forms
Used when tests, regarding Eur. Ph. 2.9.7, USP <1216> and other regulatory documents are carried out.
ERWEKA Test Machine for hardness testing of solid dosage forms
Used when tests, regarding Eur. Ph. 2.9.8, USP <1217> and other regulatory documents are carried out.
ERWEKA Test Machine for disintegrating testing of tablets and capsules
Used when tests, regarding Eur. Ph. 2.9.1, USP <701> and other regulatory documents are carried out.
PharmaTest Test Machine for disintegrating testing of suppositories and pessary tablets
Used when tests, regarding Eur. Ph. 2.9.2, USP <2040> and other regulatory documents are carried out.
Granulate forming machine (pelletyzer) GCS 200/40 equipped with water cooling system to prevent devices nodes from heating up while in operation.
Produces pellets of adjustable length via pushing wet mass through dies holes.
Machine for production and packing of suppositories (Suppository Machine) VR- consists of dosing node and refrigerator store UR-2.
Dispenses suppository mass into blister card and freezes suppositories in the refrigerator.
Machine for sealing, coding and clipping of suppositories VR-3
seals refrigerated suppositories, writes their serial numbers and cuts up suppository strip to the desired pieces.
Testing machine for packed density defining PT-TD
defines apparent volume and tapping density of powders and granules in accordance with USP, EP.
SD-1 Multifunctional laboratory aggregate for solid forms
forms consists of drive unit, reducing socket for some functional bolts and various functional bolts for mixing powder with binding liquid, swinging granulator, mixer unit for powders and powdering, coater, tableting press.
Rotary tableting press ZP-8
8-tool tableting press produces tablets of any shape on semi commercial level. Equipped with feeding unit, electromotor, tablet dust remover.
Main thermal modes are listed below:
| t, C | Relative degree of humidity, % | Expiry date | Place of storage |
|---|---|---|---|
| 25±2 | 60±2 | Before expiry date (long-term testing) | Arbitrage storage stockroom |
| 30±2 | 65±2 | 12 months (midterm testing) | Climate chamber YP-720SDP |
| 40±2 | 75±2 | 6 months (accelerated testing) | Climate chamber KBF-240 |
| Stability testing in the temperature ranges 0 ºС-70 ºС and humidity ranges 10%-80%, stress-testing, photo-stress study. | Climate chamber KBF P 240 | ||
Climate chamber KBF-240
Climate chamber YP-720SDP
Climate chamber KBF-240
| Temperature characteristics | |
|---|---|
| Temperature range without humidity | 0 / +100 С |
| Temperature range with humidity | 0 / +90 С |
| Temperature shift without humidity | ±0,5 С |
| Deviation of relative humidity | ±3 % |
- Climate chamber has microbased control humidification and dehydration systems, the chamber fully responds to the set FS requirements of stability and operating life.
- The chamber is equipped with multi-functional microprocessing screen controller with two channels: one for temperature with accuracy measurement of temperature to 0.1 ºС, and another for humidity with accuracy measurement of relative humidity to 0.1 %.
- The screen programmed controller TH300 enables to reflect diagrams on temperature and humidity change over the recent 60 hours of the chamber operation, and to reflect the current temperature and humidity in the chamber.
- In addition the chamber is equipped with air temperature limiter for emergency cutoff of air heating in the chamber, and with water temperature limiter in the steam bath for prevention of water boiling.
Climate chamber YP-720SDP
| Temperature characteristics | |
|---|---|
| Temperature range without humidity | 0 / +100 С |
| Temperature range with humidity | 0 / +90 С |
| Temperature shift without humidity | ±0,5 С |
| Deviation of relative humidity | ±3 % |
- Climate chamber has microbased control humidification and dehydration systems, the chamber fully responds to the set FS requirements of stability and operating life.
- The chamber is equipped with multi-functional microprocessing screen controller with two channels: one for temperature with accuracy measurement of temperature to 0.1 ºС, and another for humidity with accuracy measurement of relative humidity to 0.1 %.
- The screen programmed controller TH300 enables to reflect diagrams on temperature and humidity change over the recent 60 hours of the chamber operation, and to reflect the current temperature and humidity in the chamber.
- In addition the chamber is equipped with air temperature limiter for emergency cutoff of air heating in the chamber, and with water temperature limiter in the steam bath for prevention of water boiling.
Personnel
Total number of laboratory employees constitutes 30 people, 27 of them have specialized university degrees. Personnel are experienced in the fields of manufacturing, medical products quality control and analytical chemistry. R&D’s personnel take annual professional course at the leading education centers of Moscow, Saints-Petersburg, Yekaterinburg and other cities and upgrade their professional skills due to regular in-house training in compliance with GMP.
Our partners
We provide contract services on pharmaceutical development for the companies like CJSC R-Farm, Nearmedic Plus Ltd., N.C. Pharmaceuticals Ltd., Functional Products Ltd., Teva Ltd. etc.
.jpg)
