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Impurities Testing for Products & APIs
Impurities Testing for Products & APIs
From residual solvents and process-related impurities to extractables/leachables and degradant-related impurities, we offer a broad range of services in support of impurities testing. We are able to identify and quantify very low levels of impurities in the most difficult of sample matrices.Why Lancaster Laboratories?
- You can easily identify extractable compounds detected by LC/MS analysis using our non-volatile compound database consisting of more than 120 compounds.
- If you have a short term or infrequent need for testing, our self-validating method approach for residual solvents testing is a faster and more cost effective option.
- For unknown impurity identification, we offer the most extensive range of mass spectrometric approaches, including accurate mass.
- Our 30-year history of cGMP regulatory compliance ensures that you get the highest quality data.
- With extensive expertise in developing, validating and providing testing support for impurities, we can provide you with the best strategy for monitoring impurities and accelerating your drug development programs.
Leadership of Group:
Travis Emig – Director17 years with Lancaster Laboratories
Jon S. Kauffman, Ph.D. – Director20 years with Lancaster Laboratories
Tom Lehman, Ph.D. – Manager17 years with Lancaster Laboratories
Testing Available
- Residual Solvents
- USP <467> (all classes of residual solvents in current chapter)
- Customized method development/validation
- Extractables/Leachables
- Forced extraction studies
- Controlled extraction studies
- Validation of disposables for use in Biomanufacturing
- Customized method development/validation Specific example of methods include:
- Phthalate esters by GC/MS in tablets
- Benzo(a)pyrene by HPLC and GC/MS in final finished product
- Nitrosamines in metered dose inhaler O-ring components
- Trace metals by Inductively Coupled Plasma in drug products
- Process Impurities/Related Compounds
- Qualitative/Quantitative analysis
- HPLC product and API specific methodology
- Tracking/trending of resulting stability studies
- Customized method development/validation
- Degradation Products
- Forced degradation studies
- Qualitative/Quantitative analysis
- HPLC product and API specific methodology
- Tracking/trending of resulting stability studies
- Customized method development/validation
- Heavy Metals
- Qualitative/Quantitative limits testing (using ICP and ICP/MS approaches) Elemental Analysis
- Qualitative/Quantitative limits testing (using AA and CHN approaches)
Major Instrumentation
Mass Spectrometers- Thermo Scientific Accela LC/LTQ Orbitrap XL (LC/MS/MS)
- Thermo Scientific Accela LC/TSQ Vantage (LC/MS/MS)
- Thermo Scientific LTQ-XL Linear Ion Trap (LC/MS)
- Agilent (LC-TOF and Ion Trap)
- Waters Quattro Micro (LC/MS/MS)
- Agilent (GC/MS)
- Perkin Elmer Inductively Coupled Plasma (ICP and ICP/MS)
- Agilent/Waters/Thermo Scientific (HPLCs)
- Agilent (GC)
- Headspace (GC)
- Direct Injection (GC)
- Dionex ICS-3000 Ion Chromatograph (IC)
- Corona Charged Aerosol (CAD+)
- PE Graphite Furnace Atomic Absorption Spectrometer
- PE Analyst 800 Flame Atomic Absorption Spectrometer
- PE CHN Analyzer