Extractables & Leachables
Focused Analytical Services
Next Breath’s team engages with customers to define the characteristics of elastomeric component that are best suited your drug product. We will assess functionality for intended use, extractables and leachables, and physical chemical compatibility. Next Breath provides dedicated support for migration studies with placebo or active drug to help you identify potential leachables and to optimize your formulation. We keep progress moving forward through stability studies, regulatory approval and post-market approval.
Current & Future Capabilities
Current Analysis Capabilities
- Known and unknown characterization of semi- and volatile substances (GC/MS with ALS and headspace sampling capabilities), using the NIST17 library for matching of EI-generated mass spectra
- Characterization of known non-volatile substances (using a single quadrupole mass spectrometer with ESI and APCI sources, coupled to a UPLC with PDA capabilities), providing us with and the generation of unit mass resolution data for unknowns, in addition to UV spectra
- Positive analyte confirmation with the use of analytical standards (m/z and retention time)
- Ion chromatography
Upcoming Capabilities
(with a high-resolution ion mobility Q-ToF mass spectrometer coupled to a UPLC with PDA capabilities)
- The ability to characterize knowns and unknowns, including impurities in APIs and drug products
- Generation of accurate mass information
- MS/MS fragmentation pattern generation
- Molecular formula generation via accurate mass and isotope spacing information
- Collisional cross section characterization of molecules using ion mobility
- Positive analyte confirmation with the use of analytical standards, combined with retention time, accurate mass, fragmentation pattern, and collisional cross section information
- Intact mass analysis of peptides and proteins, including sequencing by MS/MS
- Examination of various post-translational modifications (i.e. glycosylation, the formation of disulfide bonds, deamidations, etc.)
Upcoming Capabilities
(with a triple quadrupole mass spectrometer coupled to a UPLC with PDA capabilities)
- Dramatically enhanced analytical sensitivities (>1500x increase in the s/n over a single quadrupole mass spectrometer)
- Ability to perform targeted trace analyte analysis (simultaneous data collection in positive, negative, and UV modes) even in the most complicated of sample matrices
- Screening and quantitation of nitrosamines and other trace impurities
Product Life Cycle Support
Component Selection Package
- Review Extractables Data Package
- Component Qualification Strategy
- Technical Assessment Report
Pharmaceutical Development
- Customized Extraction Study
- Migration Study
- Formulation Stability
- Risk Assessment Report
Regulatory Support
- Leachable study performed on stability
- Compendial Testing
- Component Change Control Studies
- Regulatory Support
Instrumentation
- LC-MS
- GC-MS
- GC-HS
- HPLC-UV
- HPLC-PDA
- UPLC
- Ion Chromatography
- ICP-MS
- FTIR
Component Reference
- Coated Stoppers
- 13 & 20 mm stoppers
- Serum stoppers
- Lyophilized stoppers
- Ready to use
- Ready to sterilize
- UDS stoppers
- Plungers
Qualifications
Next Breath has a proven track record of working with regulatory agencies to ensure a higher product approval rate.
- cGMP compliant laboratory, ISO 17025 Accredited and EQFAR certified laboratory through ANVISA
- Registered with FDA (last inspection January 2016 – no 483s)
- DEA license for controlled drug substances (schedule II-V)
- Subject matter experts in:
- Analytical chemistry
- Extractables and leachables
- Device expertise
- Particle size analysis
Regulatory Experience
Next Breath has a proven track record of working with regulatory agencies to ensure a higher product approval rate.
- FDA Guidance Container Closure Systems for Packaging Human Drugs and Biologics 1999Assay
- FDA Guidance Analytical Procedures and Methods Validation for Drugs and Biologics 2015
- ICH Q3D Guideline for Elemental Impurities
DISCOVER NEXT BREATH'S EXPERTISE
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