ANALYTICAL OPERATIONS
Potency Assay
The quality or quantity measurement of a targeted analyte, including PDEA controlled drugs, using pharmacopeia (Ex. USP, EP, BP) methods and specifications from finished products or raw materials.
Uniformity of Dosage Units
Tests the equality of the dosage in a pharmaceutical drug. This ensures that each unit has the appropriate amount of active pharmaceutical ingredients (API). Demonstrated by either Content Uniformity or Weight Variation.
Screening of Undeclared Drugs
Before being made available to the public, products marketed as dietary supplements should be screened for undeclared drugs. These undeclared drugs give therapeutic effects that can’t be achieved by only using dietary materials and may be withdrawn from the market due to adverse effects. Our laboratory can provide mass spectrometric results to give strong evidence if certain undeclared drugs are present in a product.
Quantitative Analysis of
N-nitroso-dimethylamine
(NDMA)
Tests the equality of the dosage in a pharmaceutical drug. This ensures that each unit has the appropriate amount of active pharmaceutical ingredients (API). Demonstrated by either Content Uniformity or Weight Variation.
Method Validation
Method validation is done in accordance to the requirements set by the European Medicine Agency, US FDA and ASEAN guidelines. Our highly trained staff members can perform Method Validation to the client’s method to authenticate if it is suitable for its intended use.
Bioanalysis
Bioanalysis is the measurement of the concentrations of drug analytes in plasma or serum using Liquid Chromatography and TripleQuadrupole Mass Spectrometry following US FDA, EMA, ASEAN, and Philippine FDA Guidelines.
CONTACT US
Address: 6th Floor Westlake Medical Center, National Highway, San Pedro, 4023 Laguna
Website
Laboratory
Finance
Clinical
(+63 ) 917 319 1278 /
(02) 8785 6379 / (02) 8553 8185
loc. 632 and 633
(02) 8785 6674 / (+63) 917 107 8090
(02) 8712-5647 / (02) 8553-8185
loc. 631, 634, 635