Residual Solvent Analysis

Introduction:

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.

What are residual solvents?

Residual solvents are organic solvents that may remain after manufacturing or processing. Testing helps determine specified solvent concentrations so results can be assessed against the relevant product requirements. Where additional solvent identification is needed, discuss suitability using our GC-MS testing capabilities page.

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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.

What information is needed with the sample?

Share the material type, solvent list, expected concentrations, batch details and required specification. Confirm sample quantity, container and transport requirements with the laboratory. Reliable routine testing also depends on appropriate reference and working standards.