Bora Pharmaceuticals

Bora Pharmaceuticals

1000 N. West Street,Suite 1200, Wilmington,DE 19801 USA

Analytical Testing

Analytical Testing

Bora offers a comprehensive range of analytical testing services to support your pharmaceutical development and manufacturing projects. Our laboratory was built to meet cGMP standards and is equipped with a variety of world-class instruments and equipment.

Our dedication to quality and extensive experience ensures we can assist in transferring your project from drug product development into commercial cGMP batch supply with audited regulatory compliance.

We excel in analytical method validation, transfer and verification against regulatory compendiums for drug substance, drug product (including IPC, final blending, and final goods), various compendium raw material characterization, analysis and stability monitoring.

Testing Services

Find your analytical microbiology testing solutions with Bora

We excel in analytical method validation, transfer and verification against regulatory compendiums for drug substance, drug product (including IPC, final blending, and final goods), various compendium raw material characterization, analysis and stability monitoring.Our analytical testing services include:

Compendial material analysis and wet chemistry

Method transfer, verification and validation

Residual solvents analysis per USP

Particle size analysis using different methodology (Sieve Shaker analysis , Sonic Sifter Separator, Air Jet Sieve and Malvern Mastersizer)

Manufacturing Processes Control: Cleaning validation, Bulk density, Tapped density, PSD, LOD, Disintegration, Blend uniformity, Hardness, Friability and Thickness.

Finished Products Analysis: Assay, Related Substance Impurity analysis, Dissolution (Single/Profile), Content Uniformity, Hardness, Thickness, Disintegration.

Long-term, intermediate and accelerated stability study testing.

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