Quality Control of
Small Molecules
GMP-certified quality control services for small molecules tailored strictly to individual client frameworks and universal pharmacopeia specifications.
Comprehensive QC Assays
BrownBiology Laboratory enforces tight GMP-certified quality control parameters assessing small molecule profiles spanning from raw matrices and APIs to finished products.
Whether performing targeted release investigations, specific impurity monitoring, non-routine complex technique evaluations, or standard batch releases, our dedicated arrays provide actionable endpoints tied to complete compliance.
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QC Capacities and Technologies
General Identification
IR, TLC, HPLC parameters
Assay & Dosage
UV/Vis, AAS, Titration, HPLC/UHPLC, GC, GC/MS, LC/MS and Dosage Uniformity
Related Substances
Identification and quantification (GC, HPLC, GC/MS, LC/MS)
Physical Determinations
pH, Viscosity, Density, Polarimetry, Refraction Index, Melting Point, Osmolality
Moisture & Limit Tests
Karl Fisher, loss on drying, sulfated ash, wet-chemistry tests
Impurities Analysis
Degradation products, process & drug impurities, Elemental impurities, Nitrosamines
Solid & Particulate Tests
Disintegration, dissolution, hardness, friability. Visible and subvisible particles
Inhalation & Nasal
Analysis via Andersen and New Generation Impactors
Batch Testing & Batch Release
BrownBiology Laboratory commands elite capabilities issuing GMP Certificates of Analysis (CoAs) authorized by specialized Qualified Persons (QPs). We directly manage quality control for a widening portfolio of Human medicinal products, Veterinary medicine pipelines, and deeply targeted Investigational Medicinal Products (IMPs).