- Analytical Method Developments as per ICH Q8(R2) guideline, Quality by Design (QbD) by using HPLC ( with UV, PDA, RI detectors) , GC (GCHS), GC-MS/MS , LC-MS/MS and ICP-MS for
- Active Pharmaceutical Ingredients (API)
- Intermediates
- Excipients &
- Finished dosage forms (Tablets/Capsules/Semi Solids/ Injectables )
- Analytical Method validations as per ICH Q2 (R1), MHRA and ANVISA Guidelines.
- Analytical Method Verifications and Method Transfers as per USP/EP/BP/JP/IP.
- Extractables and Leachables study as per Product Quality Research Institute (PQRI) , USP<87>, USP<88>, USP<661>, Ph. Eur. 3.1, Ph. Eur. 3.2, ISO10993, and ICHQ6A for the evaluation of materials for drug packaging, USP<1663> and USP<1664>
- Method development and Method validations for Genotoxic impurities or Nitrosamines by using LC-MS/MS and GC-MS/MS; as per USP <1469> and Ph. Eur. 2.5.42 guidelines.
- Method development and Method validations for Elemental impurities by using ICP-MS as per USP <232> and USP <233>.
- Long Term (25ºC, 60% RH), Intermediate (30ºC, 65% RH) and Accelerated (40ºC, 75% RH) stability studies for Drug Substances and Drug Products.
- Dissolution / Dissolution Profile studies.
- Residue/ Cleaning method development and method validation
- Hold Time and Carry over studies.
- Forced Degradation studies.
- Drug-Excipient Compatibility studies & Reverse Engineering.
- Photo stability study for drug substances, drug product and Intermediates.
- Raw Materials/ Drug products; Identification and Characterization studies.
- Solubility and Physico-Chemical studies.
- Raw Material, API’s, Intermediates, Excipients, Finished products testing as per USP/ EP/BP/JP/IP.
