Products & Services
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
United States of America
Audit report appendices available
Audit report available
Boston Analytical, Inc.
Country
United 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