Residual Solvent Analysis

The amount of residual solvents introduced while processing concentrates are determined by TNTH with the help of certain validated testing methods. We monitor the PPM levels of solvents which help to identify raw materials & products that are free from harmful contamination. We conduct tests for residual solvents using GC-FID coupled with headspace sampling as per USP 467 for residual solvents in pharmaceuticals. We have an unique method to indentify the light gases which are not included in USP 467. We offers testing services for propane, isobutane, n-butane, isopentane, n-pentane, isopropanol, ethanol, acetone, hexane and naphtha all in one assay.

USP <467> and ICH Q3C Residual Solvents Determination.

57 solvents are listed under Class 1 (unacceptable due to toxicity), Class 2 (solvents without sufficient Toxicological Data) or Class 3 (least toxic, ideal solvents) and , all of these need to be screened and if identified needs to be quantified under the proposed USP (& existing EP) guidelines. Tamilnadu test House Compliance Laboratories offers expert testing services for the analysis of residual solvents which are listed below as

Class 1 Residual Solvents

· Benzene

· Carbon tetrachloride

· 1,2-Dichloroethane

· 1,1-Dichloroethene

Class 2 Residual Solvents (USP Mixture A and B)

· Acetonitrile

· Chlorobenzene

· Chloroform

· Cyclohexane

· 1,2-Dichloroethene

· 1,4-Dioxane

· Hexane

· Methanol

· Methylbutylketone

· Methylcyclohexane

· Methylene chloride

· Nitromethane

· Tetrahydrofuran· Tetralin

· Toluene

· Trichloroethylene

· Xylenes

USP Class 2 Direct Injection (USP Mixture C performed upon request)

· Formamide

· 2-ethoxyethanol

· 2-methoxyethanol

· Ethylene glycol

· N-methylpyrrolidone

· Sulfolane

· Pyridine

USP Class 3 Residual Solvents

· Acetone

· Anisole

· 1-Butanol

· 2-Butanol

· Butyl acetate

· tert-Butylmethyl ether

· Cumene

· Dimethyl sulfoxide

· Ethanol

· Ethyl acetate

· Ethyl ether

· Ethyl formate

· Heptane

· Isobutyl acetate

· Methyl acetate

· 3-Methyl-1-butanol

· Methylethylketone

· Methylisobutylketone

· 2-Methyl-l-propanol

· Pentane

· 1-Pentanol

· 1-Propanol

· 2-Propanol

· Propyl acetate

USP Class 3 Residual Solvents – for Acetic acid & Formic acid by Direct injection

Our laboratory are setup with state-of-art Agilent GC’ equipped for throughput and associated headspace units. Scalablity, software & instrumentation upgrades, faster turnaround time and quality testing are our hallmark.

Generally samples are tested within seven working days of receipt. Rush testing can be performed upon client request.