SF - Quality Control Labs
Laboratory Details
PO Box 8121, 3503 RC, Reactorweg 47A
Utrecht,
3542 AD
Netherlands
Product Details
WHO Product ID
Netherlands-SHU
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Synergy Health Utrecht BV - a Steris Company
PO Box 8121, 3503 RC, Reactorweg 47A
Utrecht,
3542 AD
Netherlands
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Physical/Chemical analysis | pH, density, refractive index, optical rotation, viscosity, water content, loss on drying, conductivity, neutralizing capacity, tablet hardness, dimensions, friability, disintegration, dissolution, uniformity of dosage units (mass, content), particulate matter test (visible and sub-visible) | pH, density, refractive index, optical rotation, viscosity, water content, loss on drying, conductivity, particle size, melting point, freezing point, drop point, boiling point, distilling range |
| Microbiological Testing | Sterility test, microbial limit tests, identification of microorganisms, preservative efficacy test, bacterial endotoxins test (LAL), microbial assay of antibiotics | Sterility test, microbial limit tests, identification of microorganisms, bacterial endotoxins test (LAL), microbial assay of antibiotics |
| Identification | FTIR, (HP)TLC, (U)HPLC (UV-VIS, PDA, RI detection), GC (FID detection), UV-VIS spectrophotometry, fluorimetry, AAS/AES, basic tests | FTIR, (HP)TLC, (U)HPLC (UV-VIS, PDA, RI detection), GC (FID detection), UV-VIS spectrophotometry, fluorimetry, AAS/AES, basic tests |
| Stability testing | ICH conditions | ICH conditions |
| Assay, Impurities and related substances | (U)HPLC (UV-VIS, PDA, RI detection), GC (FID detection), (HP)TLC, UV-VIS spectrophotometry, fluorimetry, polarimetry, AAS/AES, gravimetric analysis, volumetric titrations, potentiometry, nitrogen determination, residual solvents, ethylene oxide residual analysis | (U)HPLC (UV-VIS, PDA, RI detection), GC (FID detection), (HP)TLC, UV-VIS spectrophotometry, fluorimetry, polarimetry, AAS/AES, gravimetric analysis, volumetric titrations, potentiometry, nitrogen determination, residual solvents, ethylene oxide residual analysis, oxygen flask combustion, composition of fatty acids |