Analytical R&D capabilities at Natco:
The Analytical R & D (ARD) caters to API, Formulations development for generics as well as NCEs. The ARD has ability to support small molecules, peptides and non-biological complex drugs. We also have in house capability to support a wide variety of formulations development for cytotoxic and high potency molecules in parenteral (embracing nano; liposomal & micro particulate technologies) and solid dosage forms.
A wide range of chromatographic separation techniques (HPLC, UPLC, GC, and IC) and detection techniques (UV, FL, MS, ELSD, RI, FID, TCD, etc.) to meet the requirement of different types of compounds including the ones that do not have chromophores.
- Compendial testing (USP, EP, BP, JP, etc.)
- Residual solvents by HSGC
- Control and monitoring of genotoxic and elemental impurities
- Enantiomeric separation by normal phase HPLC & GC
- Stability-indicating assay and/or related substances methods for drug substances and drug products (stress stability testing as per ICH).
- Method development, qualification, validation and transfer
- Stability protocol development and program management
- Stability storage, testing and data trending
- Cleaning validation, Detoxification studies & process validation
- Preformulation studies, Physico Chemical Characterization and Reverse Engineering
- Invitro correlation studies with RLD
- Bioanalytical studies to support preclinical and clinical studies during NCE development
Structural Chemistry and Solid State Characterisation:
- Impurity and degradation product identification and structural elucidation
- Characterisation of API, Product, Reference standards and pharmaceutical ingredients
- Analytical reference standards qualification
- Solid state characterisation for various crystalline and amorphous forms
- Physicochemical characterisation using thermal, particle size determination, dynamic vapour sorption studies, surface area analysis etc.
- Characterisation of peptide drugs and non-biological complex drugs
- Characterisation of New Chemical Entities
At the API and Formulation R&D divisions, we develop process and product specific analytical methods, which are suitable for the intended use of application. We develop various analytical methods to comply with global quality and regulatory standards.
Analytical method development for Immediate Release, Extended release, Controlled substances, for various Cytotoxic and Non Cytotoxic formulations like Tablets, Capsules (hard and soft gelatin), Powder for suspensions, Dry powder Inhalers, Injections (Liquid and Lyophilised Products), Complex Injections (like Liposomes) …. Etc.
Analytical method validations are executed in alignment with stringent SOP, which is based on ICH Q2 guidelines and in adherence to cGMP & GLP requirements.
We ensure successful method transfer to the manufacturing sites with:
- Validated robust analytical methods
- Predefined acceptance criteria
- Active involvement of qualified analysts