The variety of our analytical chemistry instruments and methods allows us to perform a broad spectrum of chemical and physical tests on finished pharmaceutical products, raw materials and excipients. In addition to routine quality control tests, our experts also perform the development and validation of analytical methods for customer-specific requests. Our service includes the preparation of analytical documentation. The various (experimental, validation, stability, etc.) protocols are prepared in accordance with current ICH guidelines and according to the customer's requirements. Tests are only performed according to valid protocols approved by the customer. Storage for stability testing is also possible without performing analytical tests.
Our services:
Quality control tests for batch release
- We undertake the complete quality control testing of sterile and non-sterile preparations according to registration documentation methods, including the testing of finished products containing highly potent active pharmaceutical ingredients (HPAPI). On the basis of the Certificate of Analysis issued by the laboratory, the product is released for sale by our Qualified Person (QP).
Testing of raw materials and excipients
- Quality control of raw materials (mostly according to cPh Eur or USP)
- Identification and determination of raw materials and ingredients
- Solvent residue tests
- Elemental contaminant testing
- Nitrosamine contaminant testing
Stability tests
- In stability testing, we can not only assist you in storing samples, but can also provide analytical testing and associated documentation in accordance with ICH and GMP guidelines, if needed. We can perform stability testing not only on finished pharmaceutical products, but also on active pharmaceutical ingredients and pharmaceutical products containing active pharmaceutical ingredients.
- We can perform the analytical tests indicated in the stability protocol on samples stored and sent for testing by our customers at the given stability time. For the tests ordered, a certificate is issued.
- We can store the samples under the following storage conditions:
- 5 °C
- 25 °C ± 2 °C/60% RH ± 5% RH
- 30 °C ± 2 °C/65% RH ± 5% RH
- 30 °C ± 2 °C/75% RH ± 5% RH
- 40 °C ± 2 °C/75% RH ± 5% RH
- 70 °C ± 2 °C/75% RH ± 5% RH
- Photo stability storage (according to ICH Q1B) can be provided by involving a subcontractor
- If needed, storage can also be arranged under specific conditions other than the above
- Our service includes the development of stability protocols and, test plans, and the preparation of stability tests and interim or final stability reports.
- Storage for stability testing is also possible without performing analytical tests.
Our experts develop and validate analytical methods according to ICH guidelines and customer requirements. The validation of analytical methods is carried out according to a validation protocol approved by the customer.
- Development of new methods and optimization of existing methods
- Validation according to ICH guidelines, customer requirements
- Preparation of validation protocols and validation reports
- Analytical method transfer (mostly based on inter-laboratory comparison)
- Development of analytical documentation (SOP)
Contact:
Dr. Tolokán Antal
+3618723634
tolokan.antal@laboratorium.hu
