Address: 50 Soldiers Field Place, Boston, MA 02135 (America)
Tel: +1(626)986-9880
Address: Allia Future Business Centre Kings Hedges Road Cambridge CB4 2HY, UK
Tel: 0044 7790 816 954
Email: marketing@medicilon.com
Address: No.585 Chuanda Road, Pudong New Area, Shanghai (Headquarters)
Postcode: 201299
Tel: +86 (21) 5859-1500 (main line)
Fax: +86 (21) 5859-6369
As of Beijing time The data is from a third-party organization and is only for reference.
For actual information, please refer to:www.eastmoney.com
© 2023 Shanghai Medicilon Inc. All rights reserved Shanghai ICP No.10216606-3
Shanghai Public Network Security File No. 31011502018888 | Website Map
Business Inquiry
Global:
Email:marketing@medicilon.com
+1(626)986-9880(U.S.)
0044 7790 816 954 (Europe)
China:
Email: marketing@medicilon.com.cn
Tel: +86 (21) 5859-1500
The production of APIs often involves complex chemical and biological changes. As the production processes are based on chemical unit reactions and chemical unit operations, resulting in by-products, purification and refinement is necessary. Impurities such as API-related substances, residual organic solvents, and inorganic impurities, as well as their physical and chemical properties, the stability of APIs, and the possibility of contamination and cross-contamination are key considerations regarding the quality, safety and effectiveness of APIs.
Medicilon offers API related services including impurity identification and separation, as well as quality research and stability testing.
• Determination of synthesis route
• Optimization of process parameter, studies of salt structure and crystal structure process, preparation and calibration of reference product
• Confirmation of laboratory process
• Production of safety assessment batch
• Production of pilot scale up
• Production of clinical batch sample (GMP)
1) Development of analytical method (starting materials, intermediates, API, Middle controlled Analysis, preliminary degradation tests)
2) Validation of analytical method (use pilot batch samples, if no pilot batch, use safety assessment batch)
3) Stability study (pilot batch or safety assessment batch + GMP batch)
• Influence factor study (in early stage, use Laboratory scale for pre-influencing factor test)
• Accelerated stability study (6 months)
• Long-term stability study (24 months or extended to 36 months)
4) Preparation and writing of declaration documents in CTD format
•Laboratory scale batch: purity 98.0%, with no significant impact on the limit of single impurity
• Safety assessment batch: purity 97.5%, the maximum single impurity control within 1.0%.
•Pilot batch: purity 99.0%, specific impurity control is less than the safety assessment batch, unknown single impurity 0.10%
•Clinical batch: purity 99.0%, specific impurity control is less than the safety assessment batch, unknown single impurity 0.10%