ANALYTICAL SERVICES

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• Analytical Testing

• Analytical Method Development and Validation

  • ​Identification of Analytical Target Profiles and Critical Quality Attributes

• Process Development and Validation

• Stability Studies

• Stability Chambers meet the full range of ICH environment requirements

• Stability-indicating assay methods for all pharmaceutical dosage forms

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• Analytical Method Development and Validation Services

  • Analytical Target Profile identification

  • Critical quality attributes identification 

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• Validation of analytical procedures

  • Identification tests

  • Quantitative tests for impurity content

  • Limit tests for the control of impurities

  • Quantitative tests of the active moiety in various samples

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• For drug substances and drug products

  • ID

  • Assay

  • Impurities

  • Residual solvents

  • Wet chemistry tests

  • Elemental impurities

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• Validated methods include (but are not limited to)

  • Chromatographic techniques such as TLC, HPLC, UPLC, GC

  • Spectrophotometric techniques such as IR, UV, ICP-MS, ICP-OES, AA

  • Titrimetric methods

  • Microbiological assays

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• Extractable and Leachable 

  • Extractables and Leachables (E&L) study helps to identify potential sources of leachables, through Controlled Extractables Studies (CES) which enable a profile of extractable components to be established.

  • Leachables Method Validation compliant to current regulations and Stability Testing for broad range of Containers, Closures, Seals, Tubing and/or Dosage Forms such as Large Volume Parenterals, Small Volume Parenterals (SVP) or Single dose products Ophthalmic Products, Nasal Products, Orally inhaled Products, Single-use and Disposable Medical Equipments, Printed Primary packaging or Secondary Packaging migration behavior of Labels, Inks, Colors and dyes, Medical devices, Implants etc.

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• Other methods

  • Fluorimetry

  • Thermo Gravimetry

  • Loss On Drying (LOD)

  • Water or Moisture by Karl Fischer

  • Powder X-ray Diffraction

  • Laser Diffraction Particle size characterization