DRUG QUALITY CONTROL
The Drug Quality Control Department conducts laboratory testing of pharmaceutical raw materials and various dosage forms based on the United States, British, European, and Japanese pharmacopoeial methods (USP, BP, Eu, Ph, JP), technical specifications submitted by the sponsor, accompanying certificates, as well as laboratory-developed and validated methods.
Single-Component and Multi-Component Medicinal Products
Tablet, Capsule, Suppository, Lozenge
Ointment, Cream, Gel, Transdermal Patch
Oral Syrup, Oral Suspension, Oral Emulsion
Solution for Injection, Powder for Injection, Lyophilized Powder
Ophthalmic Drops, Otic Drops and Nasal Drops
Spray
Pharmaceutical Raw Materials
Antibiotics, Vitamins
Pharmacological Substances belonging to other chemical classes
Testing is performed using the following methods: evaluation of the medicinal product’s appearance: color, odor, shape, clarity, determination of average weight and uniformity of weight, density, pH, osmolality, extractable/nominal volume, optical rotation, refractive index, solubility, disintegration, friability, identification, assay, related/impurity substances, moisture content, and residual solvents.
“FDA Laboratory” LLC also performs the development of new analytical methods, validation, and verification. The sponsor is provided with a comprehensive method and validation report. Documentation may be issued in Armenian, Russian, or English.
All laboratory activities are carried out by qualified specialists using state-of-the-Art and high-precision equipments.
