Development, validation, and transfer of analytical methods
Our company can provide methodological research that meets the registration requirements of NMPA, FDA, EMEA, ICH, and WHO
- Development or optimization of analysis methods
- Transfer of analysis methods
- Analytical method validation, pharmacopoeia method confirmation
- Method revalidation
Provide professional technical services for the research of various analytical methods that run through the entire lifecycle of drug development and support drug marketing and post marketing research, including but not limited to the following:
- 1. Relevant substances;
- 2. Content/uniformity of content;
- 3. Dissolution rate/multi-media dissolution curve;
- 4. Residual solvents;
- 5. Enantiomers;
- 6. Polymers and copolymers;
- 7. Genotoxic impurities;
- 8. Moisture content;
- 9. Chemical residue analysis methods;
- 10. Identification method;
- 11. Molecular weight distribution;
- 12. Particle size and particle size distribution;
- 13. Viscosity;
- 14. Insoluble particles;
- 15. Visible foreign objects.
In addition to the methods for the above-mentioned drugs, our company can also provide professional research services for qualitative and quantitative methods of excipients and small molecule chemicals.
Analysis and Control of Drug Quality
Our company has rich experience in pharmaceutical research and can provide customers with professional quality analysis technology services in generic drugs, improved new drugs, and new drugs. Our company has helped clients obtain multiple drug quality and efficacy consistency evaluation approvals, and can provide quality consistency comparison services between self-developed generic products and reference formulations. Our company can assist clients in collecting relevant research data or literature, including the quality profile of the original drug or reference formulation, screening reference formulations, filing reference formulations, conducting reverse quality studies on reference formulations, and conducting quality comparison studies between generic and reference formulations. According to actual needs, reverse analysis of reference formulations and comparative studies with generic products may include but are not limited to the following:
- 1. Content, related substances, crystal form;
- 2. Headspace oxygen content, residual solvents, pH value;
- 3. Special functional excipients: identification and content analysis of preservatives, antioxidants, and reducing agents;
- 4. Other key auxiliary materials: qualitative or quantitative analysis;
- 5. Oral solid preparations: Multi medium dissolution curve, dose dumping test;
- 6. Injection: Research on osmotic pressure, loading capacity, density, reconstitution time, compatibility stability, and freeze-thaw stability, as well as release curves of special injections;
- 7. Comparative study of impurity mass spectrometry;
- 8. Stability test research
In addition, based on the regulatory requirements of the country where the application is registered (such as China, the United States, and Europe) and the ICH guidelines, combined with reference preparations, self-developed product quality profiles (QTPP) and critical quality attributes (CQAs), as well as critical material attributes (CMA) and critical process parameters (CPP) research, release standards and shelf life standards applicable to self-developed products, as well as release standards for active pharmaceutical ingredients, excipients, packaging materials, and intermediate products of formulations, will be developed.
