Characterisation of impurities
Organic impurities in active substances must be reported, identified wherever possible, and qualified as indicated in Pharmacopeias or in ICH guidelines.
Impurity isolation and characterization is among SERICHIM’s most used services.
Preparation of reference substances
The availability of well-characterized reference substances is essential for carrying out qualitative, or accurate quantitative, analysis. The target substance is however sometimes not commercially available, and must therefore be custom made or isolated from its natural matrix. Our researchers are experts in both these techniques and deliver reference substances to our clients on regular basis.
Analytical methods development and validation
To test a specific characteristic of a substance against established acceptance criteria, an analytical method must be developed.
Method validation is generally required for assuring product quality and for achieving acceptance of products by the international agencies (US FDA, PIC/S, WHO, etc.).
In SERICHIM analytical methods are validated following ICH guidelines, preparing initial validation protocols to submit to the customer for approval, defining precision/reproducibility, accuracy, linearity, specificity/selectivity, limits of detection, limits of quantitation, and robustness of the developed method.
Our analytical services also include:
- Forced degradation study
- Chiral method development
- pectroscopic characterization (MS, NMR, IR, UV)
- Potentiometric titrations
- Melting range measure
- Boiling point measure