Non-Sterile Products

Comprehensive testing for oral, topical, and transdermal therapies 

Non-sterile products encompass a wide range of drug forms, including oral solids, liquids, topicals, transdermal patches, and silk protein products. Each requires tailored analytical methods to demonstrate purity, potency, identification, and safety. 

BA Sciences offers cGMP-compliant non-sterile product testing services that support product release and regulatory compliance across diverse dosage forms. 

Non-Sterile Product Testing Services 

Our laboratory features a full suite of studies to evaluate the quality and safety of non-sterile products, including: 

Microbial Testing (USP <61> and <62>) 

Microbial purity requirements for non-sterile products are verified using USP methods. Our microbiology team performs routine testing and develops neutralization strategies for challenging products, including antibiotics, cytotoxic compounds, and live biotherapeutic products (LBPs). 

Dissolution Testing 

Dissolution studies are carried out per USP <711> using Apparatus 1 and 2 for immediate-, extended-, and delayed-release products. Results can be analyzed by HPLC, UPLC, GC, UV, atomic absorption, auto-titration, or fluorescence instrumentation. Additional support is available for USP <711> and <724> testing with Apparatus 3, 4, 5, and 7. Methods may follow USP monographs, be transferred from clients, or be developed and validated in-house. 

Raw Material Testing 

Our cGMP-compliant laboratory conducts raw material testing to USP–NF, Ph. Eur., BP, and JP standards. When compendial methods are not available, the analytical development team designs and validates custom approaches to confirm excipient quality and performance. 

Why Work with BA Sciences 

Non-sterile product testing demands a partner who can adapt methods to different dosage forms while maintaining strict compliance standards. At BA Sciences, clients benefit from: 

• Extensive experience with oral, topical, transdermal, and protein-based products
• Full cGMP compliance and testing capabilities aligned with global compendia
• State-of-the-art instrumentation for dissolution, microbial, and raw material analysis
• Flexible method development, with validated solutions when compendial methods are not available 

Our expertise and infrastructure allow us to support projects from raw materials through finished product release with consistent, high-quality results. 

Plan Your Next Steps in Non-Sterile Testing 

Connect with us today to learn more about our non-sterile testing services and discuss your project needs.