Pharmaceutical Services

Accuracy and quality of testing drugs and pharmaceuticals is most critical than in other field, because human life is involved here. A large number of pharmaceutical, chemical, food, cosmetics and other industries trust the laboratory to provide assurance that their products are safe for human consumption.

Startech labs has facilities for undertaking the following analytical services

  • Validation on Analytical Methods of ICP-OES, Malvern Particle Size Distribution Analyzer, HPLC, GC, UV and AAS as per ICH Guidelines
  • Analytical Method Development on Particle Size Distribution Analyzer, ICP-OES, GCMS, HPLC,and GC
  • Purified Water System Validation [TOC & Micro]
  • Clean Room Validation: 
    i.Environmental monitoring Microbiological parameters.)
  • Identification & estimation of Genotoxic impurities in product by GC-MS
  • Analysis of Drugs (API) and Intermediates as per Pharmacopoeia or in-house specifications:
    i. Identification by FTIR, 
    ii. Particle Size Distribution (Dry & Wet Method) using Malvern Mastersizer
    iii. Analysis on GC-MS 
    iv. Trace Metal Analysis by ICP-OES (Perkin Elmer)
    v. Sample preparation for metal analysis by microwave digester
    vi. Purity, Assay, Related Substances by HPLC and GC
    vii.Organic Volatile Impurities and Residual Solvents estimation by GC-Headspace
    viiiHeavy metals by AAS
    ix. Potentiometric Titration(Aqueous, non Aquous, Argentometric)by MetrohmAutotitrator
    x. Moisture content by Karl Fischer Titrator
    xi. Bulk Density & Specific Gravity
    xii.Melting Range
    xiii. Microbiological tests (TBC, TFC, Pathogens)

  • Analysis of Pharmaceutical Dosage Forms (Formulations) as per Pharmacopoeia
    i. Content of drugs by HPLC, UV, GC
    ii. Dissolution Test
    iii. Disintegration Test
    iv. Friability Test
  • Testing of Medicinal & Toiletry products as per state Excise Guidelines
  • Testing of various products by using various sophisticated analytical equipment like Particle Size Distribution Analyzer, AAS, HPLC, GC, GC-MS, DSC, TGA, Elemental Analysis, TOC, UV-VIS, FTIR, etc.
  • Leachability tests
  • Photo Stability Studies of products
  • Microbiological Analysis: Assay (Vitamins & Antibiotics)
  • Microbiological Limit Tests: Total Bacterial Count, Yeast & Molds, Pathogens ( E.coli, Salmonella, Pseudomonas, Staphylococcus. aureus, etc.)
  • Antibacterial Activity of products
  • Preservative Efficacy Test (Preservative Challenge test) of formulations
  • Bacterial Endotoxins (BET) test
  • Analysis of cosmetics like Creams, Lotions, Emulsions, Gels, Oils, Talcum Powder, Scents, Sprays , Nail Polish, Perfumes, Tooth Paste, Mouth Wash, Face Wash, Lipsticks, Hair dye, etc...
  • NMR (1H & 13C), Elemental Analysis and MASS Studies of new molecules for Structural Elucidation
  • XRD, DSC, TGA and S E M studies of products
  • Calibration of Polystyrene Films and Weight Boxes
  • Trace Level estimation of Antibiotics and other Drugs in Effluent Samples
  • Analysis of herbal products like Ashwagandha, Curcumin, etc..
  • Food Analysis

QC Consultancy

  • Design of New Laboratory
  • Pre-audits for gap analysis
  • System implementation as per current requirement
  • Facilitating Technical Manpower
  • Development of Regulatory documents(Dossier, DMF etc.,) for any country
  • Other Analyrical services