SF - Quality Control Labs
Laboratory Details
National Drug Quality Control Laboratory (NDQCL), PO Box 23096, Mulago Hill
Kampala,
Uganda
Product Details
WHO Product ID
Uganda_NDA-QCL
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
National Drug Authority of Uganda
National Drug Quality Control Laboratory (NDQCL), PO Box 23096, Mulago Hill
Kampala,
Uganda
Date of last inspection
Laboratory Scope Of Tests
| Type of analysis | Finished Products | Active Pharmaceutical Ingredients |
|---|---|---|
| Assay, Impurities and related substances | (U)HPLC (UV-VIS, ELSD, DAD, FLD detection, MS/MS, MS ͤ, GC, UV/Vis, (HP)TLC, ICP-MS, FTIR spectrophotometry, limit tests, volumetric titration, Determination of related substances and impurities by comparison with reference standards. | (U)HPLC (UV-VIS, ELSD, DAD, FLD detection, MS/MS, MS ͤ, GC, UV/Vis, (HP)TLC, ICP-MS, FTIR spectrophotometry, volumetric titration, Determination of related substances and impurities by comparison with reference standards. |
| Identification | IR, (HP)TLC, (U)HPLC, GC, UPLC-q-tof (HRMS), ICP-MS, UPLC-MS/MS, (MS ͤ) spectrophotometry and basic chemical tests, Capillary Electrophoresis, Raman Spectrometry. | IR, (HP)TLC, (U)HPLC, GC, UPLC-q-tof (HRMS), ICP MS, UPLC-MS/MS (MS ͤ) spectrophotometry and basic chemical tests, Capillary Electrophoresis, Raman Spectrometry. |
| Physical/Chemical analysis | pH, Water content (Karl Fisher), disintegration, loss on drying, dissolution, uniformity of dosage units, density, dimensions, extractable volume, conductivity, visible particulate matter. | pH, Water content (Karl Fisher), loss on drying, melting point. |
| Microbiological Testing | Subvisible particulate matter, BET by MCS | Subvisible particulate matter, BET by MCS |