Analytical Method Development & Method Validation

Even in the case of Pharmacopoeial methods, cGMP calls for a detailed method feasibility study followed by method verification prior to batch testing for any regulatory submission or release testing.

Equipped with state-of-the-art instrument facilities and with a Team of experts, our Pharma Lab offers method development and method validation services as per the regulatory requirements across the globe:

• UPLC H-Class/MS/MS – Waters TQS Micro
• LC-MS/MS - Waters Xevo TQ-XS Triple Quad Mass Spectrometer
• GC-MS/MS TDS - Agilent 7000D Series Triple Quad Mass Detector
• GC-MS (5977A) Head Space - Agilent 7697A
• GC with FID and TCD detectors - Agilent 7890
• HPLCs with UV-Vis, PDA, FLD, and RI detectors - Agilent 1260 and Waters e 2695
• Ion Chromatography – Dionex ICS 5000+ with Conductivity detector
• AAS – Agilent 200 Series GTA 120 Graphite Furnace
• AAS – Agilent 289 FS with GTA
• ICP OES – Perkin Elmer 5300DV
• ICP OES – Perkin Elmer Avio 200
• ICP MS – Agilent 7700X
• ICP MS – Agilent 7800X
• FT- Infrared Spectrophotometer - Agilent Cary 630
• UV-ViS Spectrophotometer - Agilent Cary 60
• BET Surface Area Analyser - Micromeritics Gemini 2390t
• Particle Size Analyzer – Horiba LA 960 V@

Shiva Analyticals experienced analytical R&D Team excels in the method development and method validation for:

• Assays
• Related substances
• Residual Genotoxic impurities
• Residual solvents
• Volatile Organic impurities
• Residual metals
• Wet chemical analysis
• Dissolution studies
• Content uniformity

Please contact us for our Method Development and Method Validation services.