Products

Residual Solvent Analyzers

Regulatory bodies such as ICH, USP, and EP define limits for residual volatile organic chemicals in pharmaceutical formulations. To meet these guidelines, producers must monitor solvent levels in finished products, active ingredients and additives. Agilent's flexible, pre-configured and factory-tested Residual Solvent Analyzers provide quick start-up for accurate and reproducible analysis of Class 1 and Class 2A/B solvent content in pharmaceutical products. With inert sample path and excellent thermal zone stability, the Agilent 7697A Headspace Sampler automates sample handling to provide unsurpassed accuracy and repeatability with analytical precision that exceeds USP method requirements.  Choose from the 7890-based GC/FID, GC/FID/FID or GC/FID/MS configurations designed to meet your specific monitoring requirements.

  • Configured to meet the requirements for USP <467> including column, consumables, calibration/checkout samples, and analytical method facilitates adaptation to your laboratory's SOPs.
  • GC/FID analysis provides identification of organic contaminants in pharmaceutical active ingredients, formulations and additives. Using Dual FIDs provide additional confirmation.
  • Headspace thermal zone stability of ±0.1 °C, inert flow path, and use of patented Capillary Flow Technology (CFT) provides ≤3% for USP Class 1A and Class 2A/B solvents.
  • Pre-configured per industry standards and chemically tested ensuring optimal analysis of Class 1 and Class 2A/B Solvents in pharmaceutical products.
  • Includes CD-ROM with optimized retention time locked acquisition method for Residual Solvent Analysis, and quick start guide for faster method validation.
  • On-site installation and check out of the Analyzer performance by a factory certified technician confirms that your instrument and application meet Agilent’s analytical performance criteria.

Short Description

Analyzer 

Sample Types

Target Analytes 

USP 467 Residual Solvent Analyzer (HSS-GC-FID-MSD)

G3445B#481

active pharmaceutical ingredients (APIs), 
pharmaceutical formulations

Class 1 Solvents (1,1-dichloroethene, 1,1,1-trichloroethane, Carbon tetrachloride, Benzene, 1,2-dichloroethane)
Class 2A Solvents (Methanol, Acetonitrile, Dichloromethane, Trans 1,2--dicloroethene, Cis 1,2-dichloroethene, Tetrahyrofuran, Cyclohexene, Methylcyclohexane, 1,4-dioxane, Toluene, Chlorobenzene, Ethylbenzene, o,m,p-xylene)
Class 2B Solvents (Hexane, Nitromethane, Chloroform, 1,2-dimethoxyethane, Trichloroethene, Pyridine, 2-hexanone, Tetralin)

USP 467 Residual Solvent Analyzer (HSS-GC-FID)

G3445B#681

active pharmaceutical ingredients (APIs), 
pharmaceutical formulations

Class 1 Solvents (1,1-dichloroethene, 1,1,1-trichloroethane, Carbon tetrachloride, Benzene, 1,2-dichloroethane)
Class 2A Solvents (Methanol, Acetonitrile, Dichloromethane, Trans 1,2--dicloroethene, Cis 1,2-dichloroethene, Tetrahyrofuran, Cyclohexene, Methylcyclohexane, 1,4-dioxane, Toluene, Chlorobenzene, Ethylbenzene, o,m,p-xylene)
Class 2B Solvents (Hexane, Nitromethane, Chloroform, 1,2-dimethoxyethane, Trichloroethene, Pyridine, 2-hexanone, Tetralin)

USP 467 Residual Solvent Analyzer (HSS-GC-FID-FID)

G3445B#682

active pharmaceutical ingredients (APIs), 
pharmaceutical formulations

Class 1 Solvents (1,1-dichloroethene, 1,1,1-trichloroethane, Carbon tetrachloride, Benzene, 1,2-dichloroethane)
Class 2A Solvents (Methanol, Acetonitrile, Dichloromethane, Trans 1,2--dicloroethene, Cis 1,2-dichloroethene, Tetrahyrofuran, Cyclohexene, Methylcyclohexane, 1,4-dioxane, Toluene, Chlorobenzene, Ethylbenzene, o,m,p-xylene)
Class 2B Solvents (Hexane, Nitromethane, Chloroform, 1,2-dimethoxyethane, Trichloroethene, Pyridine, 2-hexanone, Tetralin)
Portable Electronic Nose PEN3

Portable Electronic Nose PEN3

GC/MS Residual Solvent Analyzers

GC/MS Residual Solvent Analyzers