Quality Services
The quality you need in less time for less money
- Raw material qualification- Final product release testing
- Metrology
- IQ/OQ instrument & equipment
- API stability studies
News & Events
See what's happening at Cedarburg Hauser Pharmaceuticals.
February 16, 2010
Cedarburg Hauser attends Informex in San Francisco
February 8, 2010
Cedarburg Hauser expands its project management team
March 17, 2009
Cedarburg Pharmaceuticals aquires Hauser Pharmaceutical Services
Analytical services for pre-clinical, clinical and commercialization stages of your API development
Cedarburg Hauser Pharmaceuticals’ on-site analytical lab and chemists make sure all processes are qualified, validated and replicated at each stage of your API’s development.
Regardless of which stage of the API development process that you’re in – Pre-clinical toxicity testing, clinical trial phase 1, phase 2, phase 3, or commercialization, Cedarburg Hauser Pharmaceuticals’ analytical chemists will ensure your API has the required level of purity and stability. Method Development, Transfer, Qualification and Validation See a list of our current analytical equipment Method development, transfer, qualification and validationCedarburg Hauser Pharmaceuticals develops analytical methods to support all stages of your API and process development. New MethodsCedarburg Hauser Pharmaceuticals develops unique analytical methods to support all stages of your product and process development. Analytical methods are validated for their intended purpose according to USP and ICH guidelines. Once the appropriate methods have been validated, we will publish comprehensive validation reports for your records. Our experienced chemists use a wide range of chromatographic and spectroscopic techniques to develop methods for: Existing MethodsCedarburg Hauser Pharmaceuticals can also optimize, transfer, qualify and validate any of your existing methods. Quality control and stability testingCedarburg Hauser Pharmaceuticals’ on-site Quality Control team offers you lower costs, quicker turnaround, convenience and close integration with the R&D chemists that are actively working on your API process development and manufacturing. Cedarburg Hauser Pharmaceuticals' experienced quality control analysts ensure your product meets cGMP standards by performing all required tests on: *Release specifications are established in conjunction with our customers. Impurity identification and testing in support of CMC filings and DMF filingsCedarburg Hauser Pharmaceuticals performs identification and structural elucidation of impurities and degradation products detected in the drug substances. Impurity studies are conducted using advanced spectroscopic techniques such as: Cedarburg Hauser Pharmaceuticals also has reliable partnerships with reputable contract laboratories to conduct sample tests including: Reference standard certificationCedarburg Hauser Pharmaceuticals performs comprehensive qualification of reference standards that are not available from USP/NF or our customers. Qualification consists of structural confirmation and quantitative purity analysis. Testing includes identity by NMR, FTIR, MS, elemental analysis, melting point by DSC, heavy metals, inorganic content by ROI, chromatographic purity, chiral purity, residual solvents analysis, and water content determinations. Once the reference standard certification is completed CHP will publish a detailed certificate of analysis.?? MicrobiologyThe cutting-edge microbiology laboratory at Cedarburg Hauser Pharmaceuticals performs microbial limits testing, bioburden testing, water testing and environmental monitoring per USP and ICH guidelines. Cedarburg Hauser Pharmaceuticals' microbiology testing services are conducted on established schedules where the data is interpreted and limits are set based on industry standards. The data is analyzed to identify trends in accordance with your needs and any appropriate regulatory agency expectations. Cedarburg Hauser Pharmaceuticals’ microbiology lab performs the following tests:
Analytical EquipmentCedarburg Hauser Pharmaceutical has a robust collection of the latest, cutting-edge analytical equipment to ensure the quality and purity of your API meets the standards and requirements your need. CHP’s current analytical equipment inventory includes: |