Services
Services
What Service We Provide
Research and Development | projects
Anaex Research Laboratory is offering Research and Development projects to a broad spectrum of industries.
Our area of expertise covers a full range of services related to total analytical support, Regulatory compliance and documentation for product registration.
Anaex Research is able to deliver customized support to each client depending upon their strategic goals like:
- Reverse Engineering
- Q1/Q2/Q3 Characterization for Drug products
- Bio waiver studies for highly soluble Drug Products
- Comparative dissolution studies (CDP) for various submission in regulatory markets
- Isolation, purification, identification of unknown impurities in drug products and drug substances
- Method development and validation for Nitrosamine impurities
- Method development and validation for Genotoxic impurities
- Protocol based studies for NG/G tube studies
- Physicochemical properties determination Log p, Log D, Pka and solubility
- API Sameness Studies
- Method development as per current regulatory requirements
- Method validation/ Method verification as per respective regulatory requirements
- Forced degradation study as per respective regulatory requirements
- Characterization of degradation impurity generated during forced degradation and its degradation pathway
- Stability Studies
- ICH Q3D – Elemental Impurities (Risk Assessment)
- Toxicological Assessments
- DMF/ANDA Support for Documentation/ Experiments/ Characterization
- ICH M7 – Genotoxicity Prediction and Assessment
Dissolution
Used in quality control and R&D to determine compliance with dissolution requirements
Place the tablet or capsule in a vessel containing a liquid medium, stir the medium to simulate stomach agitation, and measure the rate of drug release
Microprocessor dissolution test apparatus, paddle apparatus, reciprocating cylinder, piston pump, and more
