Analytical Services
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.
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.
Cedarburg Hauser Pharmaceuticals offers you a comprehensive suite of analytical services including:
Method Development, Transfer, Qualification and Validation
Quality Control and Stability Studies
Impurity Identification and CMC Testing
Reference Standard Certification
Microbiology
Method development, transfer, qualification and validation
Cedarburg Hauser Pharmaceuticals develops analytical methods to support all stages of your API and process development.
New Methods
Cedarburg 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:
• In process control of reaction completion
• Release of raw materials, intermediates and final APIs
• Equipment cleaning
• Long term stability studies
Existing Methods
Cedarburg Hauser Pharmaceuticals can also optimize, transfer, qualify and validate any of your existing methods.
Quality control and stability testing
Cedarburg 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:
• Production samples
• Reference standards
• Stability samples
Cedarburg Hauser Pharmaceuticals' quality control team uses a variety of techniques for sample analysis:
• Chromatographic assays (HPLC and GC)
• Determination of residual solvents (GC and GC with headspace)
• Spectrometry (IR, UV and MS)
• Titrations (volumetric and coulometric)
• Compendial tests (ROI, heavy metals, specific rotation, etc.)
Stability testing services offered by Cedarburg Hauser Pharmaceuticals includes:
• Formal stability protocols
• Chromatographic analyses and evaluation of results.
Validated stability storage chambers monitored under ICH guidelines are available at the following conditions:
• -20ºC
• 4ºC
• 25ºC/60%RH
• 30ºC/65%RH
• 40ºC/75%RH
Impurity identification and testing in support of CMC filings and DMF filings
Cedarburg 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:
• Mass spectrometry (LC/MS)
• Infrared spectrometry (FTIR)
• Ultra-violet (UV)
Cedarburg Hauser Pharmaceuticals also has reliable partnerships with reputable contract laboratories to conduct sample tests including:
• Nuclear magnetic resonance (NMR)
• Elemental analysis
• Inductively coupled plasma mass spectrometry (ICP/MS)
• Additional tests are also available for sample analyses with quick turnaround times
Reference standard certification
Cedarburg 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.
Microbiology
The 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:
• Microbial Limits Testing – The microbial limits test estimates the number of viable aerobic organisms present in pharmaceutical and raw materials. The test is also used to determine whether the articles harbor designated microbial species which are pathogenic in nature.
• Bioburden Testing – Bioburden, the microbial population within a product, is a used as a process control monitor. Bioburden testing is used to enumerate aerobic bacteria, spores and fungi.
• Water Testing – Water testing ensures the water is suitable for its intended use. CHP tests the water following monographs for USP purified water and includes microbial testing, total organic carbon, pH and conductivity.
• Environmental Monitoring – Environmental monitoring is conducted in manufacturing and support areas that are designated as critical to the production of a clean product. Monitoring includes testing of both viable air and surface samples and evaluation of total particulates greater than 0.5 microns in size.
Analytical Equipment
Cedarburg 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:
• NMR, 400 MHz, JEOL Eclipse
• UPLC with TUV detector, Waters Acquity
• HPLC with VWD & DAD detectors, Agilent 1100, 1200
• LC/MS, Thermo Surveyor MSQ
• GC with FID & TCD detectors, Agilent 6890, 6890N, 7890
• GC Headspace auto-sampler, PerkinElmer Turbomatrix 40, Agilent G1888
• GC/MS, Hewlett Packard 5972
• IC, Dionex ICS-2000
• FTIR Spectrometer, Bruker Vector 22
• FTIR Spectrometer, PerkinElmer Spectrum 100
• UV/Vis Spectrophotometer, Shimadzu 1601PC
• Polarimeter, Rudoph Digipol 781
• DSC, TA Instruments Q100
• Halogen Moisture Analyzer, Mettler Toledo HG53
• Autotitrator, Mettler Toledo DL55
• Karl Fisher Coulometric, Mettler Toledo C20
• Karl Fisher Volumetric, Mettler Toledo DL18