Chemical-physical tests for pharmaceutical finished products, raw mate
Our range of analyses covers a broad spectrum of chemical-physical tests of pharmaceutical products. In addition to routine quality control tests, our experts also provide the development and validation of procedures for customer-specific requests.
Our range of services
Testing of raw materials active substances according to international pharmacopoeias
- Identification and determination of APIs and ingredients
- Quality control of raw materials
- Tests for identity, content and purity according to current national and international monographs or customer regulations (Ph. Eur, USP etc.)
Release tests
- EU-Batch Release Service, including batch release by WESSLING-QP
Stability tests
We conduct long-term, short-term and in-use stability tests on ready-to-use pharmaceuticals, raw materials in accordance with current ICH and GMP specifications. The test includes the parameters relevant for stability, such as content, purity and active substance release and they are performed according to approved stability protocol.
Our service includes the development of test plans, overview tables for stability tests and individual stability reports.
Storage without commissioning analytical tests is also possible.
We can offer you the following climatic conditions:
- 25°C/60% relative humidity
- 30°C/75% relative humidity
- 40°C/75% relative humidity
- Photo stabilities
- Subtropical and tropical conditions on request
Method development, -transfer and -validation
Our pharmaceutical experts at WESSLING develop and validate methods under GMP on behalf of customers. The suitability and thus the validity of all test methods used must be proven during the approval and registration of medicinal products.
- Development of new and optimisation of existing methods
- Validation in compliance with ICH Q2 guideline
- Preparation of validation protocol
- Preparation of validation report
- Analytical method transfer
- Development of test regulations
Elemental impurities - ICH Q3D
The experts for pharmaceutical analysis competently support their customers in implementing the ICH Q3D Guideline, evaluating their active ingredients, reagents, starting materials and excipients and preparing risk analyses.
The elements are determined in our GMP laboratories using ICP-MS and ICP-OES devices.
These techniques have now found their way into international pharmacopoeias. In the European Pharmacopoeia they are listed in chapters 2.2.58 and 2.2.57, in the USP in chapter '233'. Both methods are characterised by the high selectivity and low detection limits.
Our experts at WESSLING are also happy to conduct the product-specific validation of the methods according to the ICH Q2B Guideline.
Pharmaceutical Testing Laboratory in WESSLING Hungary Ltd. performs quality control testing of pharmaceutical raw materials (APIs) and finished products.
