Analysis of medicines
The Laboratory has more than 20 years of experience in analyzing the quality of finished medical products of various formulations and different dosage forms. We carry out an analysis using pharmacopoeial methods and procedures of the manufacturer.
Detailed list of the methods used is given in the sections “Methods of analysis” and “Microbiological tests”.
In addition, we carry out verification of compendial methods and procedures of the manufacturers, as well as validation of methods/procedures developed or modified in the Laboratory.
At your request we prepare reports of:
- Analysis according to manufacturer’s procedures
- Verification of compendial methods/procedure
- Transfer of method/procedure
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