Residual Solvents Test - USP <467>

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Residual Solvents Test - USP <467>

Method Description

The Determination of Residual Solvents by Gas Chromatography-Mass Spectrometry with Headspace Sampling (GC-MS-HS) involves heating a sample to release volatile residues, which are then analyzed by GC-MS. This method ensures the detection and quantification of residual solvents in diverse matrices. GC-MS-HS provides high sensitivity and accuracy, making it essential in industries such as pharmaceuticals, ensuring compliance with safety standards and regulatory requirements. By efficiently identifying and quantifying residual solvents, this technique contributes to the quality control of products and ensures the safety of consumers.

Analyte List

Analyte Name LOD LOQ
1,2-Dichloroethane 0.4 ug/g 1.34 ug/g
2-Methylbutane 1.54 ug/g 5.14 ug/g
2-Methylpentane 0.046 ug/g 0.154 ug/g
2,2-Dimethylbutane 0.98 ug/g 3.27 ug/g
2,3-Dimethylbutane 2.19 ug/g 7.32 ug/g
3-Methylpentane 0.73 ug/g 2.44 ug/g
Acetone 1.57 ug/g 5.23 ug/g
Acetonitrile 1.85 ug/g 6.17 ug/g
Benzene 0.18 ug/g 0.59 ug/g
Butane 1.68 ug/g 5.59 ug/g
Butanes (Sum of Butane and Isobutane) N/A N/A
Chloroform 0.78 ug/g 2.59 ug/g
Ethanol 6.02 ug/g 20.1 ug/g
Ethyl Acetate 1.95 ug/g 6.49 ug/g
Ethyl Ether 1.37 ug/g 4.55 ug/g
Ethylene Oxide 0.15 ug/g 0.49 ug/g
Heptane 1.31 ug/g 4.37 ug/g
Hexane 1.42 ug/g 4.74 ug/g
Hexanes (Sum of Hexane, 2,2-Dimethylbutane, 2,3-Dimethylbutane, 2-Methylpentane, and 3-Methylpentane) N/A N/A
Isobutane 1.6 ug/g 5.34 ug/g
Isopropyl Alcohol 4.9 ug/g 16.3 ug/g
Methanol 7.89 ug/g 26.4 ug/g
Methylene Chloride 1.36 ug/g 4.53 ug/g
Neopentane 1.49 ug/g 4.97 ug/g
Pentane 1.46 ug/g 4.87 ug/g
Pentanes (Sum of Pentane, 2-Methylbutane, and Neopentane) N/A N/A
Propane 1.95 ug/g 6.51 ug/g
Toluene 1.88 ug/g 6.26 ug/g
Total Xylenes 2.02 ug/g 6.72 ug/g
Trichloroethylene 0.29 ug/g 0.96 ug/g

Technical Data Sheet

Test Name - Common
Residual Solvents Test - USP <467>
Method Name
Determination of Residual Solvents
Method Code
LAB-TM-004, LAB-TM-053
Equipment
Headspace Gas Chromatography - Mass Spectrometry (GC-MS-HS)
Method Reference
USP <467>, Cambium Analytica, Agilent
Reportable Unit
ug/g
Sample Size Requirements
Available for
Food Products, Dietary Supplements, Botanicals (Raw Materials, Extracts, Finished Products), API (Isolates, Active Ingredients) Cannabis & Hemp (Plant Materials, Extracts, Isolates, MIPs)
Unavailable for
*Prices and offerings are subject to change without notice.