Residual Solvents

USP <467> Analysis of Residual Solvents Columbia Analytical tests residual solvents as specified in USP <467> (United States Pharmacopeia). We utilize a headspace GC instrument for analyzing the various residual solvent classes. We offer method feasibility, development and validation.

Standard Analysis

As part of a standard residual solvent analysis, CAS will report all Class 1 and Class 2 solvents that are amenable to GC headspace analysis as defined in USP <467> and shown to work in practice.

To confirm the reportable list, each new test article will undergo a method suitability study to identify potential matrix interferences prior to sample analysis. This study includes an evaluation of any significant chromatographic interferences or signal suppression caused by the test article itself. This pre-evaluation of each material helps avoid lengthy delays caused by suspect results due to method limitations, and also provides additional data defensibility for FDA submissions.

Reasons for Choosing Columbia Analytical

• Expedited Turnaround Times Available
  • Standard TAT 10 days
• Accessible & Flexible
  • You will have one point of contact for seamless project management and our Quality Unit and Chemists are available upon request
• Experienced
  • Columbia Analytical has tested residual solvents since 1986; specifically performing method feasibility, development and validation for USP <467>

Compliance

Validation of methods for residual solvents conform to ICH guidances. Our laboratory is cGMP compliant, FDA inspected/registered and DEA licensed.

Columbia Analytical's Standard USP <467> List

Solvent	Concentration Limit (ppm)
CLASS 1
Benzene	2
Carbon tetrachloride	4
1,2-Dichloroethane	5
1,1-Dichloroethene	8
1,1,1-Trichloroethane	1500
CLASS 2
Acetonitrile	410
Chlorobenzene	360
Chloroform	60
Cyclohexane	3880
1,2-Dichloroethene	1870
1,4-Dioxane	380
Hexane	290
Methanol	3000
Methylbutylketone	50
Methylcyclohexane	1180
Methylene chloride	600
Nitromethane	50
Tetrahydrofuran	720
Tetralin	100
Toluene	890
Trichloroethylene	80
Xylenes	2170

Note- The following solvents are class 2 but are not volatile enough for headspace analysis. Analysis of these solvents would require an alternate validated method.

Formamide

2-ethoxyethanol

2-methoxyethanol

Ethylene glycol

N-methylpyrrolidone

Sulfolane

Pyridine

 

Learn more about USP <467>...

View residual solvent classes: Class 1 | Class 2 | Class 3

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