Intertek Pharmaceutical Contract Testing Lab, India

Intertek India is a leading cGMP compliant analytical contract testing, research and development laboratory. We provide a responsive service with dedicated customer support and deliver expert analytical testing and safety services to the highest quality standards from our experienced scientific team and state-of-the-art equipment.All major instruments in our pharmaceutical laboratory are 21 CFR Part 11 compliant with a full audit trail. 

Our experts help our clients to enhance their understanding of products and processes through the provision of expert analytical testing and insight into the meaning behind the data which facilitates informed decision making. Advanced chemical analysis services combined with an unmatched expertise in thermal safety services enables the laboratory to provide routine as well as non-routine testing and consulting support to its clients across a range of industries. In particular, the team provide screening tests for thermal hazards posed by combustible dusts including intermediates and finished dosage forms for the pharmaceutical industry.

With our global network of laboratories we routinely provide bioanalysis, physico-chemical and structural characterisation and potency testing for some of the most innovative companies involved in the development and manufacture of biologic medicines such as antibodies, biosimilars and vaccines.

Pharmaceutical Services

• Extractables & Leachables Studies
• Method Development & Validations
• Elemental Analysis as per ICH Q3D
• Glass Delamination Studies
• Stability Storage
• Batch Analysis as per Pharmacopoeia/In-house/Customer Method
• Dissolution Studies

 Instruments

• GC-MS
• GC-HS-MS
• LC-MS/MS
• ICP-MS
• Ion Chromatography
• HPLCs with UV & Fluorescence Detector
• Dissolution Apparatus
• FTIR

• Registered with USFDA (FEI number 3014466106)
• Approved by Maharashtra FDA
• GLP certified

Safety Services

We offer following specialised Safety Services for R&D and Plant safety.

Dust and powder explosivity and ignition tests:

• Combustible Dust Screening Test (in Modified Hartmann Tube): Go/No Go Test
• Minimum Ignition Energy (MIE), ASTM ASTM E-2019-99/VDI 2263 Part 1
• Burning Test or Combustible Test
• Minimum Auto-ignition temperature of dust clouds and Dust Layer.
• Dust  Lower Explosivity Limit (LEL) or Minimum Explosible Concentration ( MEC)
• Maximum Explosion Over-pressure (Pmax)
• Dust Specific Characteristic / Dust Severity Test (Kst)
• Limiting Oxygen Concentration (LOC)

Process safety and thermal stability testing:

• Reaction Calorimeter (RC1e)
  o  Kinetic reaction data
  o  Thermodynamic reaction dataThermal Stability data, from Differential Scanning Calorimetry (DSC)
• Thermal Stability indices, using Accelerating Rate Calorimetry (ARC®)
• Certification: NABL Accredited

Vendor Qualification Services

We perform Vendor Qualification as third party auditor as a part of vendor evaluation by clients for India & other countries. Our Auditors are ECA trained & are ISO certified Auditors. We perform GMP audits as per 21 CFR 210 and 211.