Expertise in In-Vitro Studies and Q3 Characterization
We specialize in conducting in-vitro studies and Q3 characterization for various semi-solid dosage forms, including ophthalmic and otic preparations. Our studies adhere to product-specific guidance and regulatory guidelines.
State-of-the-Art Laboratory Facilities
Our analytical and formulation laboratories are well-equipped to perform:
– In-Vitro Release Testing (IVRT)
– Dissolution studies
Comprehensive Physicochemical and Structural Characterization
We provide complete Q3 characterization of topical drug products, including:
– Comparative evaluation of generic and reference products
– Assessment of sameness, similarity, and difference as per regulatory guidance
– Experienced Team of Scientists
Our dedicated team of scientists has extensive experience in managing multiple projects, including:
– Development and validation of in-vitro and Q3 characterization studies
– Addressing regulatory queries from agencies
Comparative Study Parameters
Description and Packaging
Finish dosage form description
Packaging configuration comparison
Physical Properties
Viscosity/Rheology
Specific Gravity
Hardness
Friability
Disintegration Time (DT)
Globule Size
Melting Range
Penetrability
Folding Endurance
Elongation
Breaking Force
Morphological Properties
Particle Size Distribution (PSD)
In-Vitro Study
Comparative in-vitro study
Dissolution USP Type I, II & IV
Chemical Properties
Potency
Nuclear Magnetic Resonance (NMR)
Mass Spectrometry
Polymorphic Form
These parameters provide a comprehensive framework for comparing the test product with reference products, covering physical, chemical, and in-vitro aspects.