Solvent for Residual Solvent Analysis

Residual solvents in pharmaceuticals are classified into Class 1 to Class 3 according to the ICH guidelines on residual solvents in pharmaceuticals (ICH Q3C), based on the risk that may affect human health, and are strictly controlled. The Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP) specify a highly sensitive analytical method using headspace gas chromatography (HS-GC) as a method for testing residual solvents in pharmaceuticals. However, some of commercial solvents contain other impurity / residual solvents (low-boiling compounds). When you use a solvent for which no residual solvent is guaranteed and a solvent peak is detected, it is not clear whether the peak is derived from a sample or solvent, and it may be impossible to obtain accurate results. Solvents "for Residual Solvent Analysis" of FUJIFILM Wako is a series of solvents that reduce and guarantee residual solvents in the solvents. 2 types of series are available. One is a "for ICH Q3C Analysis" with guaranteed residual solvents listed in ICH Q3C Classes 1 to 3, and the other is a series with guaranteed 4 types of residual solvents selected by FUJIFILM Wako.

for Residual Solvent Analysis
(for ICH Q3C Analysis)
for Residual Solvent Analysis
Guaranteed Solvents Solvent species listed in ICH Q3C Classes 1 to 3* The 4 types of solvents selected by FUJIFILM Wako (Acetone, Ethanol, Methanol, and Hexane)

*Some solvents are not guaranteed. For details, see the specifications.

for Residual Solvent Analysis (for ICH Q3C Analysis)

Impurity / residual solvents (low-boiling compounds) in solvents are reduced.

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59 types of residual solvents listed in ICH Q3C Classes 1 to 3 are guaranteed.

In addition to the guaranteed solvents of “for residual solvent Analysis” grade, the following solvents listed in ICH Q3C Classes 1 to 3 are guaranteed.

▼Class 1 (max. 1 ppm)

Carbon tetrachloride 1,2-Dichloroethane 1,1-Dichloroethene 1,1,1-Trichloroethane Benzene

 

▼Class 2 (max. 10 ppm)*1

Acetonitrile Ethylbenzene 2-Ethoxyethanol o-, m-, p-Xylene Chlorobenzene
Cumene*2 Chloroform Cyclohexane 1,2-Dichloroethene 1,4-Dioxane
Dichloromethane N,N-Dimethylacetamide N,N-Dimethylformamide 1,2-Dimethoxyethane Sulfolane
Tetrahydrofuran*2 Tetralin Toluene 1,1,2-Trichloroethene Nitromethane
Pyridine Hexane Methanol Methyl isobutyl ketone*2 Methylcyclohexane
N-Methylpyrrolidone Methylbutyl ketone 2-Methoxyethanol

*1: Ethylene glycol and formamide are not guaranteed.
*2: Guaranteed at max. 50 ppm

 

▼Class 3 (max. 50 ppm)*3

Acetone Anisole Ethanol Ethyl formate Acetic acid
Isobutyl acetate Isopropyl acetate Ethyl acetate n-Butyl acetate Propyl acetate
Methyl acetate Diethyl ether Dimethylsulfoxide 1-Butanol 2-Butanol
t-Butylmethyl ether 1-Propanol 2-Propanol Heptane 1-Pentanol
Pentane Methyl ethyl ketone 3-Methyl-1-butanol 2-Methyl-1-propanol

*3: Formic acid and triethylamine are not guaranteed.

for Residual Solvent Analysis

Solvents that reduce residual solvents in the solvents and guarantee that the following 4 types of solvents are not more than 0.1 ppm

▼Guaranteed Solvents (max. 0.1 ppm)

Acetone Ethanol Methanol Hexane

*The guaranteed solvents are different from those “for residual solvent Analysis (for ICH Q3C Analysis)”.

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for Residual Solvent Analysis (for ICH Q3C Analysis)

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Author: A. Samoveanu

For research use or further manufacturing use only. Not for use in diagnostic procedures.

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