Some tests performed by our laboratory:
- Assay and impurities content in sugars and sugar alcohols (sucrose, glucose, trehalose, fructose, maltose, maltotriose, lactose, sorbitol, mannitol and others) using Ca++ and Na+ polymeric columns (Waters Sugar-Pak, Rezex RNM – Carbohydrate Na +) and a refractometric detector
- Capsaicin and capsaicinoides in medicines and plants using HPLC-UV
- Assay and purity of insulin using a special ( for example, Waters Insulin HMWP) chromatographic columns.
- Molecular mass distribution of dextrans using method of exclusion chromatography with refractometric detection
- Determination of chiral purity of API (clopidogrel, cetirizine, levocetirizin, amino acids) using Ultron ES-OVM, Chiralcel OD-R columns
- Assay of paclitaxel and impurities using the pentafluorophenyl (PFP, F5) column and HPLC-UV method
- Determination of preservatives in medicines (methylparaben, propylparaben, benzyl alcohol, potassium sorbate) using HPLC-UV
Approbation of methods/procedures of analysis
The laboratory may provide qualified consulting assistance in approbation (verification) of methods/procedures for testing of medicines and assistance in the development and/or transfer of analytical method/procedure.
Our priorities in approbation of method/procedure:
- Checking compliance with pharmacopoeia requirements
- Identification of weaknesses in the method/procedure and their verification in agreement with the customer scope
- Recommendations for method transfer plan
- Correction of the text and formulas