Irvine Pharmaceutical Services

NEWS

USP UPDATES AND EVENTS

Residual Solvents Testing

ASSURE COMPLIANCE NOW WITH IRVINE’S COST EFFECTIVE IDENTIFICATION AND QUANTIFICATION OF IMPURITIES

Irvine provides expert, rapid analysis of all three classes of residual solvents. Our USP/ICH compliant, state-of-the-art laboratory and experienced team of scientists allow you to manage the large number of methods that may be involved in identification and quantification of impurities, including residual solvents.

Irvine’s Expertise Encompasses:

Strict compliance of ICH guidelines
Detection, profiling and control support of residual solvents in drug substances, excipients, and Drug products
Water-soluble/Water-insoluble raw materials and APIs
Screening for potential interference
Screening for identification of unknown peaks
Feasibility studies
Validation of analytical methods
Assistance in regulatory reporting
Comprehensive and accurate reports

Irvine’s Multiple Points of Interaction:

Joint review of DMF/physico-chemical properties of the API
Meetings to ensure appropriate
Technology GC-FID or GC/MS
Limits, e.g., TDI
Procedure for method transfer/validation
Process prescreening, routine testing, API qualification

Faster Analysis, Enhanced Sensitivity

Irvine remains committed to ongoing, effective upgrades in software and instrumentation so you can benefit from faster, more selective and sensitive testing. Currently, you benefit from Irvine's state-of-the-art equipment that reduces the number of separation phases.

Agilent GC/MS with Head Space Analyzer (6890N GC System, 5975 inert XL Mass-Selective Detector, G1701DA ChemStation software.)
Combi PAL CTC Autosampler System for headspace and liquid injection

REQUEST A PROPOSAL TODAY!



NEWS USP UPDATES AND EVENTS CONFERENCE CALENDAR INDUSTRY UPDATES Extractables and Leachables Mycoplasma Detection Residual Solvents Testing Elemental Impurities DOWNLOAD FACT SHEET HOME	Residual Solvents Testing

	ASSURE COMPLIANCE NOW WITH IRVINE’S COST EFFECTIVE IDENTIFICATION AND QUANTIFICATION OF IMPURITIES

	Irvine provides expert, rapid analysis of all three classes of residual solvents. Our USP/ICH compliant, state-of-the-art laboratory and experienced team of scientists allow you to manage the large number of methods that may be involved in identification and quantification of impurities, including residual solvents.

	Irvine’s Expertise Encompasses:
	Strict compliance of ICH guidelines Detection, profiling and control support of residual solvents in drug substances, excipients, and Drug products Water-soluble/Water-insoluble raw materials and APIs Screening for potential interference Screening for identification of unknown peaks Feasibility studies Validation of analytical methods Assistance in regulatory reporting Comprehensive and accurate reports
	Irvine’s Multiple Points of Interaction:
	Joint review of DMF/physico-chemical properties of the API Meetings to ensure appropriate Technology GC-FID or GC/MS Limits, e.g., TDI Procedure for method transfer/validation Process prescreening, routine testing, API qualification
	Faster Analysis, Enhanced Sensitivity
	Irvine remains committed to ongoing, effective upgrades in software and instrumentation so you can benefit from faster, more selective and sensitive testing. Currently, you benefit from Irvine's state-of-the-art equipment that reduces the number of separation phases.
	Agilent GC/MS with Head Space Analyzer (6890N GC System, 5975 inert XL Mass-Selective Detector, G1701DA ChemStation software.) Combi PAL CTC Autosampler System for headspace and liquid injection

	REQUEST A PROPOSAL TODAY!