NDA Analytics has many years of experience
in the testing of both sterile and non-sterile liquid dosage
forms, including large volume parenterals (LVPs), small
volume parenterals (SVPs), injectables (including autoinjectors),
oral solutions and suspensions and ophthalmic formulations.
Tests provided for these dosage forms
include:
Assay of active ingredient
Assay of related impurities and degradation products
Assay of preservative
Impurity limit tests
Particle size distribution and limit tests
Refractive index measurement
Osmolality measurement
Density measurement
Viscosity measurement
pH measurement
Dissolved oxygen measurement
Ion concentration measurement by ion-selective electrode
and titration
Excipients assay
Appearance and clarity tests
Fill volume measurement
Resuspendability evaluation
Sterility testing
Microbial limit tests
Preservative efficacy tests
Bacterial endotoxins (kinetic and gel clot LAL tests)
