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Responding to Global Pharmaceutical Tests

LC Solvents for JP, USP, Ph. Eur.

The solvents for the Pharmacopoeia General Test (for LC) comply with the reagent grades of the Japanese Pharmacopoeia, the United States Pharmacopeia (USP), and the European Pharmacopoeia (EP, Ph. Eur.). It supports global pharmaceutical tests. USP and Ph. Eur. have different grades for different applications within the same solvent type, and the absorbance measurement wavelength range and content specification values are defined according to the grade. Our solvent for the Pharmacopoeia General Test (for LC) grade is assured up to the highest grade of both USP and Ph. Eur. And we assure our own test items and stricter specifications in addition to the specifications of each pharmacopeia.

Features

  • Compatible with the solvent standards of the Japanese Pharmacopoeia, USP (ACS), and Ph. Eur.
  • In addition to General Use, assures up to Specific Use (UV Spectrophotometry, LC Suitability) grades. (USP)
  • Assures R1 for acetonitrile and R1 and R2 for methanol. (Ph. Eur.)
  • We have added our own test items and specification values, and some of them are assured to be stricter than the specifications of each pharmacopeia.

Comparison of the Specifications of Each Pharmacopeia and Our Product Assure Items

Comparison of the specifications of each pharmacopeia and our assured items for the Japanese Pharmacopoeia General Tests (for LC) (Acetonitrile)*

Item JP USP Ph. Eur. Assured items for
the Japanese Pharmacopoeia
General Tests
for Liquid
chromatography
ACS Spectro
photometric
Spectro
photometry
for
Chromatography
R1
General
use
Specific Use
UV
spectrophotometry
LC
suitability
Description Colorless
clear liquid
Colorless
clear liquid
Colorless
clear liquid
Colorless
clear liquid
Colorless
clear liquid
Colorless
clear liquid
Colorless
clear liquid
Colorless
clear liquid
Colorless clear liquid
(JP, USP, EP)
Assay - min. 99.5% min. 99.5% min. 99.5% min. 99.5% - min. 99.8% min. 99.9% min. 99.5% (USP)
min. 99.9% (EP)
Distillation range
(80~82℃)
Not less than 95% Not less than 95% Not less than 95% Not less than 95% (EP)
Density (20℃) - - - - - - - - 0.780~0.783 g/mL
Specific gravity ( d2020 ) - - - - - about 0.78 about 0.78 about 0.78 about 0.78 (EP)
Refractive index (n20D) - - - - - about 1.344 about 1.344 about 1.344 about 1.344 (EP)
Absor-
bance
190 nm - - max. 1.00 max. 1.00 - - - - max. 1.00 (USP)
200 nm max. 0.07 - - - - - - max. 0.10 max. 0.07 (JP)
max. 0.10 (EP)
210 nm max. 0.046 - - - - - - - max. 0.03
220 nm max. 0.027 - max. 0.05 max. 0.05 - - - - max. 0.027 (JP)
max. 0.05 (USP)
230 nm max. 0.014 - - - - - - - max. 0.014 (JP)
240 nm max. 0.009 - - - - - max. 0.01 - max. 0.009 (JP)
250 nm - - - - max. 0.01 - - max. 0.01 (EP)
254 nm - - max. 0.01 max. 0.01 - - max. 0.01 (USP, EP)
255 nm - - - - max. 0.01 - max. 0.01 (USP, EP)
280 nm - - - - - max. 0.01 (USP, EP)
420 nm - - - - - - max. 0.01 (EP)
Fluorescence test - - - - - - - - to pass test
Water (H2O) - max. 0.3% max. 0.3% max. 0.3% max. 0.3% - - - max. 0.3% (USP)
Residue after evaporation - max. 0.005% max. 0.005% max. 0.005% max. 0.005% - - - max. 0.005% (USP)
Titrable
acid
equivalent - max. 8 μeq/g max. 8 μeq/g max. 8 μeq/g max. 8 μeq/g - - - max. 8 μeq/g (USP)
CH3COOH - - - - - - - - max. 0.001%
Titrable
base
equivalent - max. 0.6 μeq/g max. 0.6 μeq/g max. 0.6 μeq/g max. 0.6 μeq/g - - - max. 0.6 μeq/g (USP)
NH4 - - - - - - - - max. 0.3 ppm
Color (APHA) - max. 10 max. 10 max. 10 max. 10 - - - max. 10 (USP)
Gradient elution - - - to pass test - - - - to pass test (USP)
pH - - - - - Neutral
to litmus paper
Neutral
to litmus paper
Neutral
to litmus paper
Neutral
to litmus paper (EP)
Peroxide (as H2O2) - - - - - - - - max. 5 ppm
Substances
reducing permanganate
- - - - - - - - to pass test
*The above information is current as of October 2022. For the latest information, please refer to the latest version of the each pharmacopeia.

Corresponding Range of Our Solvent (for the Japanese Pharmacopoeia General Test (for LC) grade) in Each Pharmacopeia Solvent Type*1

Item JP USP Ph. Eur.
for Liquid
chromatography
ACS Spectro
photometric
Spectro
photometry
for
Chromatography
R*2 R1 R2
General
Use
Specific Use
UV
Spectrophotometry
LC
Suitability
Acetonitrile
Methanol
Hexane
Tetrahydrofuran,
Stabilizer Free*3
- - -
*1 Please refer to the product specification sheet (link) for the specifications of each item.
*2 R: Reagant
*3 Ph. Eur. is not assured.

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Product content may differ from the actual image due to minor specification changes etc.

If the revision of product standards and packaging standards has been made, there is a case where the actual product specifications and images are different.

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