Detection of residual solvents in drugs by headspace gas chromatography

Residual solvents in drugs refer to organic volatile compounds used in the drug production process that cannot be completely removed. As residual solvents have no therapeutic effect, all residual solvents should be removed as much as possible to meet product specifications, GMP, or other basic quality requirements.

The residual solvents and limits of methanol, ethanol, acetone, and methyl acetate are shown in the following table:

Solvent name	Concentration limit (%)
methanol	0.3
ethanol	0.5
acetone	0.5
methyl acetate	0.5

1、 Main instruments:
1.1 GC-9860 gas chromatograph, equipped with capillary column injection port and FID detector;
1.2. AHS-10A automatic headspace sampler
1.3 DB-624 chromatographic column;
1.4 BF-2L air generator;
1.5. BF-300E hydrogen generator;
1.6 Other experimental instruments and reagents.IIChromatograms of residual solvents in methanol, ethanol, acetone, and methyl acetate



IIISix needle reproducibility chromatograms of residual solvents in methanol, ethanol, acetone, and methyl acetate



Beijing Beifen Sanpu Instrument Co., LtdWe are an analytical instrument manufacturer that integrates research and development, production, sales, and service.Main production: gas chromatograph, headspace sampler, thermal analyzer, analytical tube aging analyzer, digital soap film flowmeter, hydrogen generator, air generator, nitrogen generator and other products
The company has a group of experienced engineers who have been engaged in the development, analysis, and maintenance of chromatography instruments for a long time. They have strong technical strength in the maintenance, repair, and debugging of chromatography instruments. In recent years, we haveMany placesHigher education institutions, research institutions, production enterprises, and inspection and testing institutions provide a large number of analytical instruments and equipment, as well as complete system solutions. It is precisely because of our high-quality products and comprehensive pre-sales and after-sales services that we have won the support and trust of our customers, and have a good reputation.

Specially provide the following dedicated gas chromatographs:
1Complete set of blood alcohol analysis (drunk driving test) instruments for testing;
2Detection of residual ethylene oxide in masks;
3Indoor air benzene, toluene, and xylene component detection;
4TVOC component detection in indoor air;
5Detection of dimethyl ether in liquefied gas;
6Gas chromatograph for detecting non methane total hydrocarbons in the air；
7Gas chromatograph for detecting epichlorohydrin and epichlorohydrin；
8Analysis of trace hydrogen in water;
9Non methane total hydrocarbon dedicated gas chromatograph；
10Analysis of VOC components in cigarette packs, ink, and cigarette paper;
11Analysis of heptafluoropropane fire extinguishing agent by gas chromatography；
12Gas chromatograph for methanol analysis in Baijiu;
13Chromatograph for residual solvents in plastic flexible packaging
Beijing Beifen Sanpu Instrument Co., Ltd
Technical Department