The FDA requires comparative studies on the impurity profiles of multiple batches of proposed products and the Reference Listed Drugs (RLDs). However, incomplete or excessive research may bring unnecessary burden to the pharmaceutical equivalence evaluation, and also bring more time cost and financial resources consumption to generic companies.
Alfa Chemistry provides comprehensive services according to the FDA requirements:
- Study potential impurities with higher risk
- Design a reasonable control strategy by performing a simplified procedures
- We carry out research with full consideration of characteristics of the product based on a comprehensive research of the RLDs and the published guidance on impurity analysis
- Introduction of a variety of analysis methods: literature search, analysis of raw materials, forced degradation testing
Our Services
At Alfa Chemistry, based on the investigation of the characteristics of your drug product, information of the RLDs, and relevant technical guidelines, our expert team identify the impurities and control them to ensure that the impurity level of the proposed product is consistent with that of the RLDs.
Our state-of-the-art laboratories with strict quality control systems support the implementation of various testing protocols. Impurity profile service is completed by Alfa Chemistry's experienced experts with many years of project execution experience in various fields including process analysis, organic component analysis, and inorganic component analysis.
- Impurity profile strategy: literature search, analysis of raw material characteristics, forced degradation test
- We provide analytical services for both oral solid dosage forms and injections
- Automatically generated data report: degradation pathway of drug substance, comprehensive study of compatibility testing
Pharmaceutical manufacturer needs to demonstrate the suitability of its analytical method. In general, we refer to the existing standard methods of your proposed generic product. When the established analytical method is different from the existing one, we provide comparative data on the detection results in terms of system applicability and detection sensitivity to demonstrate the robustness of the detection ability of the established method. Our analytical method establishment services include: analytical method development, optimization and verification.
- Control and maintain the impurity level in the product to be consistent with that in the RLDs
- Our analysis services are available for different dosage forms including oral solid preparations and injections
- Delivery of reliable pharmaceutical equivalence data
Services Support for Impurities Analysis
- Re-evaluation, screening and optimization of the prescription process
- Selection of packaging materials
- Compatibility analysis
- Structural confirmation and toxicology studies of impurities
Features of Our Services
- Customized analysis solutions to meet your specific demand
- Precise identification of impurities with high potential risks
