Primera Analytical Solutions

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Audited
Audit report available

Headquarters

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Sites

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Products & Services

Assessment of Leachables & Extractables in Drug Product

Bioassay Analysis For Release

Country

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Audit report appendices available
Audit report available

Primera Analytical Solutions

Country

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City

Cranbury, New Jersey

Address

Prospect Plains Road 259, 08512 3706

This audit report also includes the following appended documentation:

  • GMP certificate
  • List of SOP
  • Organization chart
  • Plant layout

Chiral Separation

Cleaning Validation

Coulometric and Volumetric Karl Fischer Testing

Drug Substance Impurity Profiles

Heavy Metal Analysis by ICP/MS

Residual Solvents

SEC-Analyze, XRD, 4-Chlorobutyl Chloride, Limit Of Trazodone Related Compound F And Exyxlophoshamide Related Compound A, Identification By Mass Spectrometry For Cetrorelix Acetate Drug Substance, Testing Of Glatiramer Acetate As Part Of The Manufacture Of A Product For Commercial Purposes.

Country

Flag of United States of AmericaUnited States of America
Show site details
Audit report appendices available
Audit report available

Primera Analytical Solutions

Country

Flag of United States of AmericaUnited States of America

City

Cranbury, New Jersey

Address

Prospect Plains Road 259, 08512 3706

This audit report also includes the following appended documentation:

  • GMP certificate
  • List of SOP
  • Organization chart
  • Plant layout

Stability Studies