Potency Assays (Chemical potency assay)

Identification Tests

Content Uniformity Tests

Related impurities test

We use High Performance Liquid Chromatography and UV-Vis Spectrophotometer for the Monograph Testing of finished pharmaceutical products to determine the accuracy and precision of product label claims and compendial limits.

We partner with local Clinical Research Organizations (CROs) in conducting BA/BE Studies. Upon completion of the clinical phase by the CRO, the biological samples are forwarded to BioAnalytica Inc. for bioanalysis.

We utilize both High-Performance Liquid Chromatography (HPLC) Instrument and Liquid Chromatograph tandem Mass Spectrometer (LCMSMS) to develop accurate, sensitive and precise methods for the analysis of drugs in blood plasma or serum samples. Our methods are capable of establishing a time-concentration relationship of the active ingredient relative to its presence in the bloodstream. Our LCMSMS and HPLC are used to analyze the following:

Plasma/serum samples from Bioavailability/Bioequivalence (BA/BE) Studies of generic drugs

Plasma/serum samples from Bioavailability/Bioequivalence (BA/BE) Studies of biosimilars

Plasma/serum samples from Pharmacokinetic (PK) Studies of drugs

Single-point Dissolution Tests (Compendial and Batch-release Tests)

Multi-point Dissolution Tests

Comparative Dissolution Profile Testing

We provide a variety of dissolution tests using the Dissolution tester – from single point to comprehensive dissolution profile.

We also perform comparative dissolution profiling for innovators to check the quality of their test product with reference drugs that have an established dissolution profile.

We provide stability testing services to local and international clients for their products following the ASEAN stability guidelines for Zone IVB.

Stability testing is performed utilizing a variety of techniques, from HPLC, UV-VIS, microbiological, FT-IR and wet chemistry analysis.