Analytical Testing Services for Drug Substance and Drug Product Quality
The pharmaceutical industry is responsible for the research, development, production, and distribution of medications and drugs used for prevention, treatment, and management of various medical conditions. The quality, safety, and efficacy of pharmaceutical
The identity, strength, purity, and quality of pharmaceutical products from early development through commercial release depend on analytical testing. Testing expectations vary by dosage form, phase, and regulatory region—but accuracy, consistency, and clear documentation are always nonnegotiable aspects.
BA Sciences delivers pharmaceutical testing services aligned with FDA, ICH, and global regulatory standards. We work with manufacturers and developers across the product lifecycle, supporting stability, release, and microbiology testing with tailored protocols and expert guidance.
Our Pharmaceutical Testing Capabilities
- Raw material and excipient testing
To verify identity, purity, and conformance with pharmacopeial specifications. - In-process and release testing
To evaluate potency, uniformity, and other critical quality attributes of drug substances and finished products. This includes support for antimicrobial effectiveness and preservative efficacy testing, pyrogen validation, and particulate matter analysis as required. - Stability testing and storage
To support ICH-compliant storage conditions and long-term, accelerated, and stress condition studies. Photostability and thermal cycling testing can be included as part of development or regulatory submissions. - Pharmaceutical microbiology testing
To perform USP <71> sterility testing, USP <85> bacterial endotoxins testing (LAL), bioburden, USP <51> antimicrobial effectiveness, microbial limits testing, and biological indicator—resistance performance tests (USP <55>). We also conduct bioburden hold time and microbial kill rate studies. - Particulate and physical property analysis
To assess appearance, particulate matter (USP <788>), and performance characteristics as required.
