SF - Quality Control Labs
Laboratory Details
1 Science Park Drive
Singapore,
118 221
Singapore
Product Details
WHO Product ID
Singapore-TUV SUD PSB
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
TÜV SÜD PSB Pte Ltd, Chemical & Materials (Food & Pharmaceutical Testing)
1 Science Park Drive
Singapore,
118 221
Singapore
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Assay, Impurities and related substances | HPLC (UV-Vis, PDA, fluorescence, RI detection), GC (FID, MS, TCD, ECD), FTIR, UV-VIS spectrophotometry, volumetric titrations. Determination of related substances/impurities by comparison with reference standards | HPLC (UV-Vis, PDA, fluorescence, RI detection), GC (FID, MS, TCD, ECD), FTIR, UV-VIS spectrophotometry, volumetric titrations. Determination of related substances and impurities by comparison with reference standards |
| Identification | HPLC (UV-Vis, PDA, fluorescence, RI detection), GC (FID, MS, TCD, ECD), TLC, FTIR, UV-VIS spectrophotometry, optical rotation, basic tests | HPLC (UV-Vis, PDA, fluorescence, RI detection), GC (FID, MS, TCD), TLC, FTIR, UV-VIS spectrophotometry, optical rotation, basic tests |
| Microbiological Testing | Sterility test, microbial limit tests, bacterial endotoxins test (LAL), preservative challenge test, antimicrobial effectiveness, microbial assay of antibiotics | Sterility test, microbial limit tests, bacterial endotoxins test (LAL), preservative challenge test, antimicrobial effectiveness, microbial assay of antibiotics |
| Physical/Chemical analysis | pH, loss on drying, water content (Karl Fischer), disintegration, dissolution, density, dimensions, uniformity of dosage units (mass, content), limit tests | pH, loss on drying, ash, melting point, water content (Karl Fischer), heavy metals (AA, ICP-MS), acid value, acid neutralizing capacity, iodine value, limit tests |
| Stability testing | ICH conditions | ICH conditions |