Key role in determining the quality of the active pharmaceutical product and drug product, is the validation of the Analytical procedure.
The quality of the Pharmaceutical product should be monitored and determined from its initial design stage. This relates to the product’s active ingredient, other raw materials and excipients used as well as the actual manufacturing and cleaning processes. This is why, proper analytical solutions and validation is an integral part of the pharmaceutical product and is performed under the strictest requirements of international regulatory authorities (FDA, EPA, ICH, EP, USP and OECD).
Medical Devices are also required to undergo various chemical analyses such as determination of chemical composition, potential extractables or leachables, or identification of residues that are related to manufacturing processes and should not be present in the final product. Tests related to the product’s shelf-life may also include chemical testing.
Analyst Research Laboratories specializes in developing, validating and testing of APIs and drug products, as well as various chemical tests related to medical devices.
Some of the services we provide include:
- Assay of API and Formulated Materials
- USP/EP Drug Substance and Drug Product Testing
- Impurities & Degradation Product Analysis
- Cleaning Validation for Facilities
- Residual Solvents and OVI by Headspace-GC
- Dissolution Tests
- Loss on Drying
- Stability Studies
- Stability-Indicating Methods
- Five Batch Analysis
- Biochemical Testing (Enzymes and Inhibitors)
- QC Testing