Labs
About CRC Labs
Our experienced personnel have been involved in numerous FDA submissions that have seen the successful approval of new drug applications. CRC Labs is a cGMP and FDA inspected lab. We routinely issue Certificate of Analysis that are required for the releasing and monitoring of final manufactured products. Our staff has over 50 years of pharmaceutical experience.
Our Mission
CRC laboratories’ mission is to provide outstanding pharmaceutical services at affordable prices. Our emphasis is on creating an environment that will provide fast, accurate analysis and reporting catered to the needs of our customers. Our staff strives to effectively communicate and interact with our clients to ensure a positive experience with your testing requirements.
Laboratories Services and Capabilities
- Laboratory Facilities Management
- Regulatory Services
- Report Writing
- FDA inspected cGMP laboratory
- Proficient in peptide analysis
- HPLC Analysis
- Assay, Identification, and Purity
- Detection by:
- UV, Fluorescence, and Electrochemical
- HPLC method development
- HPLC method validation
- Moisture Content (Sensitive to 10 mcg of water)
- Particle Testing
- Stability Testing
- Stability chambers constantly monitored at:-70°C, -20°C, 5°C, 25°C, and 40°C
- FTIR Identification Analysis
- Loss on Drying
- Analytical Microbalances
- Accurate down to 1 and 0.1 micrograms
- Small Scale Lyophilization for:
- Method Development
- Production of reference standard material
- UV Spectrophotometry
- LC Purification using:
- High throughput flow rate (Large columns)
- Appearance Testing
- Reconstitution Testing
- Special customized analytical testing requests available.
- Assist in troubleshooting manufacturing including in-process testing when necessary.
