In the field of pharmaceutical field, it is crucial to have a reliable and accurate platform for analytical testing to ensure the safety and efficacy of drug development and research process. With state-of-the-art instruments and equipment and a team of highly skilled scientists and technicians who are dedicated to providing top-notch analytical services, our analytical testing center provides comprehensive services to support drug development processes, from early stage research to product commercialization. Our center is designed to meet the industry standards for drug development and is committed to delivering results with a quick turnaround time.
Our Analytical Testing Platform
At our analytical testing center, we offer a range of services to support drug discovery and development efforts. Our platform can be further divided into:
We work closely with our clients to tailor our services to meet their specific needs and requirements. Please click the links for details.
Service Scope
Through our comprehensive analytical testing technology listed above, we support you in a series of key business activities in the process of drug development to market launch. Our analytical testing platform can serve:
Method Development
- Development and optimization of analytical methods in the process of process route screening
- Sample detection of various physical and chemical properties and chromatography related in the process of process screening
- Impurity identification in the process of process screening
2
Pilot Scale-Up and GMP Production
- Completion of API analysis method validation
- Completion of API quality standard determination
- Product release testing
4
Structural Analysis and Standardization of Reference Materials
- Impurity and API structural analysis (NMR, MS, IR, UV, EA, XRD)
- API reference material standardization (NMR, HPLC, GC, KF, ROI)
6
1
Process Route Determination, Pilot and GLP Analysis Work
- Determination of analysis methods
- Factor experiments and preliminary validation of analysis methods
- Collection and establishment of initial quality standard information
3
Stability Studies for Regulatory Compliance
- Conduct stability studies according to ICH, Chinese Pharmacopoeia guidelines and others
- Provide stability protocols and stability reports
- Estimate API retest period based on stability data
5
Submission of IND Application Data
- Write content for Section 3.2.S.4 API analysis as required for the application
- Submit application analysis content
- Accept audit checks from clients and authorities
Instruments and Equipment
Our analytical testing center is equipped with a wide range of instruments and equipment to support our testing capabilities. The main instruments and equipment include:
- HPLC（DAD/CAD）
- LC-MS
- LC-MS/MS
- IC
- DVS
- Auto Titrators
- Prep-HPLC
- GC
- UPLC-MS/MS
- KF
- TOC
- Thermal Safety
- Stability Chamber
- ...
- GC-MS
- GC-MS/MS
- ICP-MS
- DSC/TGA
- XRPD
- PSD
Our state-of-the-art equipment allows us to conduct a variety of analytical tests with high precision and accuracy.
With our team of experienced scientists and top-of-the-line instruments and equipment, we are committed to providing reliable and accurate analytical testing services to support the advancement of pharmaceutical research. Contact us today to learn more about how our platform and services can benefit your projects.
Related Services
It should be noted that our service is only used for research, not for clinical use.
