Overview of custom synthesis
The R & D team of our company is composed of experienced scientific research experts from China and abroad. It is characterized by technological innovation and comprehensive technical ability. It has extensive and in-depth professional knowledge in the field of synthetic organic chemistry. It can independently design compound synthesis routes and has rich experience in dealing with complex compounds.
Our company has a complete quality management system, QA, QC and R & D& and production leaders have rich GMP production experience, participated in the preparation of IND application documents and CDE on-site verification, familiar with the rules and strategy stages of new drug R & D and application, and provide reliable and compliant technical services and products to customers.
Development, Optimization, Manufacturing, and Submission (DMF) Content for the Custom Synthetic Manufacturing Process
Product Project Establishment:
Research, project evaluation and consultation
Design a synthetic route with intellectual property rights and cost advantages
Route screening
Confirmation of crystal form
process optimization
quality study
Three batches of small-scale test, pilot test, at least three batches of cGMP process validation
stability test
Development and Validation of Analytical Procedures
Technology transfer, etc.
Collation of application dossier and preparation of application dossier in CTD format (DMF)
Pharmaceutical Analytical Method Development and Methodology Validation
Analytical method development and validation for related substances/assay, including forced degradation
Development, qualification or validation of chiral methods for pharmaceuticals
Method development, qualification or validation of residual content of impurities
Development, qualification or validation of KF and CKF analytical methods for moisture
Development, qualification or validation of thermogravimetric analysis (TGA) methods
Cleaning Validation Test Method Development, Validation or Verification
Compilation of Submission in CTD Format (DMF)
Drug Stability Studies
Experimental/exploratory stability study (pre-experimental) and stability study in drug registration stage
According to ICH Q1A, design corresponding stability test according to drug properties
Stability data of analytical samples under different conditions were evaluated according to ICH Q1E
such as trend of data over time
Comprehensive analysis to establish the shelf life and shelf life of samples
Equipped with strong light test chamber and stability test chamber
Storage conditions: 30°C/40°C/75%RH, 30°C/65%RH, 25°C/60%RH and light
Stability study constant temperature and humidity chamber; Real-time temperature and humidity monitoring (dual system); automatic alarm system
Compilation of Submission in CTD Format (DMF)
Drug impurity analysis
Separation of impurities in regulated starting materials, intermediates, APIs and drug products using various techniques such as HPLC
Complete 1D/2D NMR, LCMS, EA, HRMS, IR, UV data were collected to identify the structure of the separated impurities
Isolation and structure identification of forced oxidation degradation products
Compilation of Submission in CTD Format (DMF)
