Analytical services for pre-clinical, clinical and commercialization stages of your API development
Cedarburg 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 Pharmaceuticals’ analytical chemists will ensure your API has the required level of purity and stability.
Cedarburg 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
Method development, transfer, qualification and validation
Cedarburg Pharmaceuticals develops analytical methods to support all stages of your API and process development.
Cedarburg 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
Quality control and stability testing
Cedarburg 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 Pharmaceuticals’ experienced quality control analysts ensure your product meets cGMP standards by performing all required tests on:
- Production samples
- Reference standards
- Stability samples
Cedarburg 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.)
*Release specifications are established in conjunction with our customers.
Stability testing services offered by Cedarburg 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:
Impurity identification and testing in support of CMC filings and DMF filings
Cedarburg 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 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 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 Cedarburg Pharmaceuticals will publish a detailed certificate of analysis.
Cedarburg 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.
Cedarburg’s current analytical equipment inventory includes:
- UPLC with TUV detector, Waters Acquity
- UHPLC, Agilent 1290 Infinity Series
- HPLC with VWD & DAD & CAD detectors, Agilent 1100, 1200
- LC/MS, Thermo Surveyor MSQ
- GC with FID, Agilent 6890, 6890N, 7890
- GC Headspace auto-sampler, PerkinElmer Turbomatrix 40, Agilent G1888
- GC/MS, Hewlett Packard 5972
- IC, Dionex ICS-2000
- FTIR Spectrometer, PerkinElmer Spectrum 100 with UATR Bounce Assembly
- UV/Vis Spectrophotometer, Shimadzu 1601PC
- Polarimeter, Rudolph Autopol V Plus (capable of multiple wavelength analysis)
- Refractometer, Rudolph J357
- 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