Any pharmaceutical product manufacturer requires a quality control, which is one of the Pre- requisite to regulatory compliances. A significant portion of the cGMP regulations and all pharmacopeia methods such as USP, IP, EP, JP, BP and In-house methods pertain to the quality control testing of products. Actimus provides expert analytical services in all areas of testing from raw materials, excipients, APIs, Bulk drugs, intermediates to finished products. Actimus sophisticated pharmaceutical testing lab operates as an extension of your QC and Analytical R&D laboratories.
Data Integrity is being handled in compliant with (21 CFR Part 11) regulations subsections (a) to (k).
- Extractactable and Leachable Studies.
- Elemental Impurities studies by using ICPMS.
- Drug substance Assay and RS Method Development and Validation
- Drug Product Assay and RS Method Development and Validation
- Unknown Impurity Identification by LCMSMS and GCMSMS
- Genotoxic impurities quantification by LCMSMS and GCMSMS.
- Nitrosamines content quantification by LCMS and GCMS.
- Physicochemical characterization studies.
- Quality control and release testing.
- Deformulation studies (reverse engineering studies).
- In-Vitro equivalence Studies by using HPLC & IC.
- Polymorph studies by using TGA/DSC and PXRD.
List of Equipment:
- HPLC LC-2030C Plus (Shimadzu iseries)
- ICPMS(Perkin Elmer-Nexion 2000
- LCMS/MS Shimadzu-8060
- GC-MS/MS - Agilent (7010B GC/TQ, 8890 GC)
- Ion Chromatography - Thermo (ICS-5000)
- TGA/DSC - Mettler Toledo (TGA.DSC 3+)