SK Health Care | Innovations

Analytical R&D capabilities at SK Health Care Formulations:

Analytical R&D is responsible for the creation of APIs and formulations for generics and NCEs. It is capable of supporting tiny chemicals, peptides, and complicated non-biological medicines. Additionally, we have the competence to assist the creation of a broad range of formulations for carcinogenic and high-potency compounds in intravenous and solid pharmaceutical formulations.

Structural Chemistry and the Characterization of Solid States:

Detection and molecular elucidation of impurities and degradation products.
Characterization of pharmaceutical formulations, products, reference standards, and pharmaceutical components.
Qualification of analytical reference standards.
Analysis of different crystalline regions forms in the solid-state.
Thermosyphon heat, particle size measurement, dynamic vapor sorption investigations, and surface area analysis are all used to characterize the physicochemical properties.
Identification and characterization of peptide and non-biological complex medicines.
Identification and Characterization of New Bioactive Molecules.

Method Development:

We create a technique and product-specific methodological approaches that are suited for the intended purpose of application at the API and Formulation R&D divisions. We create a variety of analytical techniques to ensure compliance with international quality and regulatory requirements.

Method Validation:

Analytical technique validations are carried out in accordance with strict SOPs based on ICH Q2 recommendations and in compliance with cGMP and GLP regulations.

Transfer Method:

We assure the successful transfer of methods to production sites by doing the following:

Analytical techniques that have been validated and proven to be robust.
Clearance criteria are established.
Active participation of qualified researchers.