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Lebanon - Arwan QCL

SF - Quality Control Labs
Laboratory Details
Quality Control Laboratory for Pharmaceutical Testing, 3-Jadra Real Estate, Jadra Chouf
Mount Lebanon,
Lebanon
Product Details
WHO Product ID
Lebanon - Arwan QCL
Status
Prequalified
Date of prequalification
Type
Prequalified Lab
Applicant organization
Arwan Pharmaceutical Industries
Quality Control Laboratory for Pharmaceutical Testing, 3-Jadra Real Estate, Jadra Chouf
Mount Lebanon,
Lebanon
Date of last inspection
Type of analysis Finished Products Active Pharmaceutical Ingredients
Assay, Impurities and related substances HPLC (UV-Vis, PDA, RI, fluorescence), UV-Vis spectrophotometry, AAS, FTIR, volumetric titrations, TLC, potentiometry, Analytical Test method validations. HPLC (UV-Vis, PDA, RI, fluorescence), GC FID, UV-Vis spectrophotometry, AAS, FTIR, volumetric titrations, TLC, potentiometry, Analytical Test method validations.
Microbiological Testing Sterility test, microbial limit tests, bacterial endotoxins test (LAL), microbial assay of antibiotics, preservative efficacy test, Test method validations. Sterility test, microbial limit tests, bacterial endotoxins test (LAL), microbial assay of antibiotics, Test method validations.
Physical/Chemical analysis pH, density, appearance, color intensity, optical rotation, viscosity, water content, conductivity, limit tests, acidity, alkalinity, tablet hardness, friability, disintegration, dissolution, uniformity of dosage units (mass content), loss on drying, particulate matter test, extractable volume, dimensions. pH, optical rotation, viscosity, melting point, loss on drying, water content, osmolarity, conductivity, heavy metals, limit tests, acid value, iodine value, peroxide value, ester value, hydroxyl value, density, sulphated ash, residue on ignition, total organic carbon, solubility.
Identification HPLC (UV-Vis, PDA, RI), TLC, UVVIS spectrophotometry, FTIR, AAS. HPLC (UV-Vis, PDA, RI, conductivity, fluorescence, detection), GC (FID), TLC, UV-VIS spectrophotometry, basic tests, capillary electrophoresis, FTIR, AAS.
Stability testing Stability testing for all required ICH zones Stability testing for all required ICH zones. Stability testing for all required ICH zones Stability testing for all required ICH zones.