Kalidindi Siva Prasad Kumar

Group Lead @Etico Lifesciences Pvt. Ltd

Hyderabad, IN

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 forActive Pharmaceutical Ingredients (API)IntermediatesExcipients & 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, USP, USP, Ph. Eur. 3.1, Ph. Eur. 3.2, ISO10993, and ICHQ6A for the evaluation of materials for drug packaging, USP and USPMethod development and Method validations for Genotoxic impurities or Nitrosamines by using LC-MS/MS and GC-MS/MS; as per USP and Ph. Eur. 2.5.42 guidelines.Method development and Method validations for Elemental impurities by using ICP-MS as per USP and USP.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.

Andhra University

Master of Science, Organic Chemistry