Analytical Services We Provide
SITEC LABS provides expert analytical services in all areas of testing from raw materials, excipients, APIs, Bulk drugs, intermediates to finished products.
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+)
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- Analytical Research division is state-of-the art facility well-equipped with many sophisticated analytical instruments like MALVERN and SYMPHATEC PARTICLE SIZE ANALYZERS, GC-MS, AAS, XRD, DSC, TGA, CHNSO etc.
- Laboratory is equipped with latest models of HPLC systems with Variety of detectors like UV-VIS, FLUORESCENCE, ELECTROCHEMICAL, REFRACTIVE INDEX, PDA DETECTORS etc. All these systems are 21CFR Part 11 complaint.
- Also Laboratory has latest models of GCs with Headspace and Liquid auto-injectors and with FID, TCD and MS detectors.
- Analytical data management systems, meeting to the needs of 21CFR compliance.
- Laboratory have all the required equipments like CASCADE IMPACTOR, TWIN IMPIGNER, UNIFORMITY OF DELIVERED DOSE APPARATUS etc., to perform analysis of pressurized metered dose inhalers (pMDI) and dry powder inhalers (DPI).
- State-of-the-art Microbiological testing facility for Microbial Limits Tests, Bioassays, Sterility etc.
- With the help of talented research technicians and scientists and exceptional instrumentation, Laboratory is continuously investigating new innovative approaches to analytical testing.
- Walk-in Humidity Chambers for Stability studies of Pharmaceutical products as per the latest ICH Guidelines.