Residual Solvents

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Residual Solvents

USP <467> Analysis of Residual Solvents

ALS Environmental 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.

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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.

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Headspace GC-MS for testing residual solventsReasons for Choosing ALS Environmental

  • 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
    • ALS Environmental has tested residual solvents since 1986; specifically performing method feasibility, development and validation for USP <467>
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Compliance

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

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ALS Environmental'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

 

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

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