Product Development Services- QC and Microbiology Testing
Azopharma offers QC and microbiological testing for Active Pharmaceutical Ingredients (APIs), pharmaceutical intermediates, excipients and finished products.
Azopharma has hundreds of standard operating procedures, rigorous compliance systems and a detailed training program that allows for successful execution of quality control testing. Our QC analytical laboratories ensure that your products are safe and efficacious from the raw material to the finished product.
Azopharma methods utilized for QC services include:
- Client methods
- In-house developed and validated procedures
- USP methods
- PhEur methods
- JP/JPE methods
- BP methods
- ACS monographs
- AOAC testing
- DAB compendial tests
- FCC testing procedures
Azopharma supports the following pharmaceutical
development activities in our QC services group:
- Non-traditional methods execution
- Testing of APIs and intermediates
- In-process testing support
- Process validation design and validation testing
- Finished product release and stability
- Container-closure testing
Microbiology capabilities include:
- Methods development/validation
- USP/EP/JP compendial testing
- Micro limits testing
- Antimicrobial effectiveness testing
- Water systems testing and validation
- Metabolite ID and screening
- Endotoxin testing
- Particulate matter
- Sterility testing
- Cell based assays
- ELISA and gels analysis