SPECIALIZED ANALYTICAL SERVICES
Specialized Analytical Services
In the development of complex generic products, standard analytical methods often fall short. Our Specialized Analytical Services are designed to address these challenges using advanced, fit-for-purpose techniques. From intricate impurity profiling to comprehensive structural characterization, we provide the deep analytical insight needed to support regulatory compliance, formulation development, and product differentiation. Trust our expertise to navigate the complexities of today’s pharmaceutical landscape.
Key Capabilities in Specialized Analytical Techniques
Product Deformulation
Studies to identify the key ingredients and their quantities attributing the defined quality attributes to a reference drug product.
In Vitro Release Testing (IVRT)
Semisolid drug products, in vitro release testing (IVRT) has shown potential in evaluating drug release properties. An in vitro release rate can reflect the combined effect of several physical and chemical properties, including solubility and particle size of the active pharmaceutical ingredient (API) and rheological properties of the dosage form.
Rheological Behaviour Testing
It helps in understanding how a material responds to applied forces this testing evaluates the flow properties, viscosity, and elasticity of a product to ensure it performs as intended during manufacturing, storage, and application especially liquids, semi-solids, suspensions, and polymers.
Particle Characterization
Characterization of the materials (API / Excipients) used in the drug product is the most critical aspect of drug product development to achieve its desired therapeutic effect. Critical Particle Attributes include, Particle Size distribution, Crystal state & Morphology
Polymorph Studies
characterization of different crystalline forms (polymorphs) of Active Pharmaceutical Ingredient (API) — to understand how these variations affect the drug’s properties, performance, stability, and manufacturability in the Finished product.
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