Boston Analytical

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Audited
Audit report available

Headquarters

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Sites

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Products & Services

Analytical Testing Raw Materials

Antimicrobial Effectiveness Testing USP 51

Assay and Purity Testing of Products

Biological Indicator Testing USP 55 and USP 1035

Class 100 Glove Box Isolator with VHP Sterilization System

Cleaning Validation

Direct Inoculation Testing Under USP/EP Guidelines

Dissolution Analysis (Apparatus I – V & VII)

Elemental Analysis via Inductively Coupled Plasma

Endotoxin Testing Under USP/EP Guidelines

Extractables & Leachables Analysis

Finished Product Release

HPLC & GC with Various Detectors

ICH & FDA COMPLIANT STABILITY TESTING FOR DRUG DEVELOPMENT

Impurities Related Compounds

In-Process and Lot Release Testing

Method Development and Validation

Microbial Enumeration Testing USP 61

Parameter Testing Of Raw Materials / APIs

Country

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Audit report appendices available
Audit report available

Boston Analytical, Inc.

Country

Flag of United States of AmericaUnited States of America

City

Salem, NH

This audit report also includes the following appended documentation:

  • Authorisations
  • DEA inspection
  • FDA inspections (includes Warning-letter)
  • ISO 17025 certificate
  • Organization chart

Particulate Analysis USP 788 and USP 789

Residual Solvents

Stability Testing and Storage Support

USP Compliance Product Testing

USP Monograph Testing

Waters UPLC (Ultra Performance Liquid Chromatography)

Water Testing USP 1231 USP 643 USP 645