Intertek Pharmaceutical Services
|
|
|
|
|
|
|
|
 
Intertek OCA Home > Intertek Pharmaceutical Services > Pharmaceutical Product Testing

Product Testing
Pharmaceutical Related Testing Capabilities
Clinical Supplies:
  • Release testing
  • Stability testing
  • Comparator studies
  • Method development and method validation
  • DEA schedule I-V licenses
  • Post package ID

Finished Products:
Isolations:
  • Preparative chromatography
  • Isolations
  • Structure elucidation
  • Purity assignment

Purification of Actives:
  • Preparative chromatography
  • Isolations
  • Purity assignment

Comparator Studies:
  • Method development and method validation
  • Release testing
  • Stability storage and testing
  • Dissolution and assay method
  • DEA schedule I-V licenses
  • For compendial and propriety products
  • Reference Standards
  • Product Experience (click this link to visit our case studies)


Extractables and Leachables:
  • Extractable and Leachables Services
  • Develop HPLC, GC, and ICP methods for controlled extractables from pharmaceutical containers/closures/devices
  • Identify extractables using GC/MS and LC/MS – obtain a profile
  • Modify appropriate controlled extractable methods for use in routine extractable testing
  • Validate the routine extractable methods for product release
  • Modify appropriate controlled extractable methods for use in leachables testing
  • Obtain a leachables profile
  • Validate the leachables method for incorporation into a stability program

Reference Standards:

Complete Characterization:
  • Identification  (CHN, X, O, IR, UV/Vis, NMR (H1& C13), MS)
  • Physical  (Melting/Boiling Point, Optical Rotation, TGA, pH)
  • Purity  (HPLC, Residual Solvents, Titration, KF, Metals Screen, ROI)

RSM Program Intertek QTI performs the following services to provide a complete solution for corporate RSMs:
  • Initial Characterization
  • Generation of a Certificate of Analysis
  • Expiry Dating through stability testing
  • Repository & Distributor
  • Periodic Re-qualification
    • Complete Characterization of Sample Limited RSM
  • Especially designed for impurities, metabolites, or other expensive materials
  • Typical characterization methods requires 1 – 2 grams of material for complete characterization
  • Sample Limited RSM characterization methods requires 100 – 200 milligrams of material for complete characterization
Intertek Laboratory Services
 Contact for more information
Americas Email Enquiries
Europe Email Enquiries
Asia Email Enquires
 Prefer to Call?
Americas: 1 908 534 4445, x669
Europe: +44 (0) 161 721 5247
Print This Page