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Professional Services

Boston Analytical provides the highest quality analytical testing services to Pharmaceutical, Biopharmaceutical and Medical device companies worldwide

Boston Analytical, the life sciences division of Alpha Analytical, is a premier cGMP compliant, FDA and DEA registered, and ISO/IEC-17025:2005 Certified laboratory for pharmaceutical analytical testing. We provide the highest quality testing services to Pharmaceutical, Biopharmaceutical, and Medical device companies worldwide. Since 1987, Boston Analytical has remained dedicated to customer satisfaction, and to the timely and accurate analysis of your products.

  • Reliable, trusted results
  • High-quality, customizable testing and reporting
  • Quality systems that eliminate or reduce risks
  • Rapid, consistent turnarounds
  • Superior customer service with unparalleled responsiveness
  • Highly educated staff of experts
  • Equipped with the latest analytical testing technology

Microbiology Testing Services

Boston Analytical's microbiology testing services are performed according to official USP/EP standards, and, where applicable, to AAMI and ISO guidelines:

  • Biological indicator testing
  • On-site environmental monitoring
  • USP purified water testing
  • Water activity testing
  • Microbial identification
  • Sterility testing
  • Bacterial endotoxin testing

Stability Testing Services

Boston Analytical offers a comprehensive line of stability testing capabilities to meet ICH and FDA guidelines for drug development and follow-up stability studies, including:

  • Stability storage
  • Thermal cycling stability testing
  • Photostability testing & photodegradation studies
  • Clinical registration & annual stability studies
  • Blind comparator stability studies
  • Formulation development & optimization

Analytical Testing Services

Boston Analytical has been performing world-class Analytical Development - Validation and Analytical Chemistry testing for the Pharmaceutical industry since 1987. We would be glad to partner with you on:

  • Method development & validation
  • USP testing
  • In-process & lot release testing
  • Raw material testing

Boston Analytical's innovative and intelligent analytical testing processes and methods are time-tested and proven to meet all the demands of potency, purity, and stability.

Analytical Testing Processes:

  • Stability indicating & robust method transfer
  • Impurities/degradation products
  • Method evaluation/optimization
  • Cleaning validation
  • Process validation

Analytical Testing Methods:

  • Assay/purity
  • Impurities/related compounds
  • Finished product release
  • Dissolution apparatus I-V & VII disintegration
  • Drug release profiles automated sampling
  • Residual solvents <467>
  • Atomic absorption
  • HPLC/GC with various detectors
  • Ion chromatography
  • USP monograph testing
  • ICP-MS Analysis