Our dedicated team of analytical scientists with formidable expertise in pharmaceutical industry, and state-of-the-art instrumentation allow us to design and execute a plethora of analytical applications. These strengths we have developed an expertise to work on a broad spectrum of molecules including peptides, conjugated sugars and small molecules.
We at Omgene believe in conceptual understanding of quality. Our scientists strive to explore the physicochemical characteristics of molecules by undertaking impurity profiling, degradation studies and stability studies using validated analytical methods by sophisticated analytical and spectroscopic techniques. Our expertise in peptide purification and lyophilization ensures high quality products for diverse healthcare applications.
The Analytical development group works coherently with the Organic Synthesis and Formulation Development groups. Technology-transfer teams are well placed to provide all essential and stage-wise support to our clients on their API’s scale-up needs.
Specification and STP for API, Excipients & Finished Product with identified and justified Critical Quality Attributes.
Highly experienced analytical research development team houses instrumentation like HPLC equipped with UV, PDA, RI and ELSD detectors, Preparative HPLC, LC-MS-MS, Dissolution apparatus, UV spectrophotometers, Karl Fischer apparatus, Lyophilizers etc.
- Method development and validation.
- Assay, Related substances, Forced Degradation, Stability studies and wet analysis of Intermediates, API’s and Formulated products.
- Isolation and purification of impurities, intermediates and API’s using Preparative HPLC.
- Dissolution Analysis.
- Content Uniformity, Blend Uniformity studies.
- Drug Excipient Compatibility studies.