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Central Laboratory Analytical Services (CLAS)

Central Laboratory Analytical Services (CLAS) is a cGMP/GLP compliant and US FDA inspected analytical testing facility established in the year 2019.

We offer a consultative, multi-disciplinary approach as part of analytical services to meet current regulatory requirements

Services we offer

  • Analytical Method Development, Analytical Method Validation and Transfer (Assay, Organic Impurities, Enantiomeric Purity, Residual Solvents, Dissolution and Content Uniformity).
  • Routine QC tests for raw materials, intermediates, API and Formulation as per Pharmacopoeia and/or client specific methods.
  • Polymorphic Identification and quantitation by XRPD technique.
  • Elemental Analysis by ICP-MS as per ICH Q3D in line with USP<232>, <233> & EMEA guideline and/or client specific requirement.
  • Genotoxic impurity evaluation by a suitable analytical technique, in line with ICH M7 control limit based on TTC approach.
  • Nitrosamine impurity quantification of a sensitive and rugged analytical methods by GC-MS/MS and/or LC-MS/MS.
  • Extractable & Leachable Studies using different techniques like GC-MS/MS, LC-MS/MS, ICP-MS and Ion Chromatography. Services are performed as per USP (<1663>, <1664>, <1664.1>), PQRI recommendations and/or client requirements.
  • Q1 and Q2 sameness studies for complex generic products & Reverse Engineering support for Quantitative estimation of selective inactive ingredients in RLD products
  • Stability Studies for drug substance and drug products.

List of Instruments

S.NoInstrument NameMakeModel
1ICP-MSAgilent7800
2Microwave Accelerated Reaction SystemCEMMARS 6
3LC-MS/MSAgilent1260 Infinity II/6470A
4LC-MS/MSAgilent1290 Infinity-II/6470A
5LC-MS/MSWatersAcquity H-Class/TQ-S Micro
6GC-MS/MSAgilent7890B/7000D
7GC-MSAgilent8890B/5977C
8XRPDBrukerD8 ADVANCE A25
9Ion ChromatographyMetrohm930 Compact
10Ion ChromatographyMetrohm940 Professional IC Vario
11HPLC with PDA DetectorWaterse2695/2998
12HPLC with UV DetectorWaterse2695/2489
13HPLC with UV & RI DetectorWaterse2695/2489&2414
14HPLC with UV & ELSD DetectorWaterse2695/2489&2424
15GC with HeadspaceAgilent7890B &7697A
16Dissolution Test ApparatusLab IndiaDS8000 SMART
17Precision BalanceRADWAGPS600.X2
18Electronic Semi-Micro BalanceRADWAGXA82/220.4Y
19Micro BalanceRADWAGMYA 5.4 Y
20Centrifuge with CoolerEltekRC8100F
21Micropipettes (5-100µL & 50-1000 µL)EppendorfXplorer plus
22Laboratory OvenNihaarNEPL408S
23PH MetersLab IndiaPico+
24Cooling ChamberNihaarNEPL116RTCSI

Accreditations

Drug Control Administration

US FDA Inspected

DUNS Registered

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