Responding to Global Pharmaceutical Tests

Solvents for Three Pharmacopoeias

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The solvents for the Pharmacopoeia General Test (for liquid chromatography) complies with the reagent specifications of the Japanese Pharmacopoeia, the United States Pharmacopeia, and the European Pharmacopoeia. It also supports global pharmaceutical tests.

Features

It is guaranteed moisture, non-volatile substances, changes in refractive index due to impurities, UV absorption, fluorescent substances, and peroxides listed in the Japanese Pharmacopoeia, USP (ACS), and EP.

Specification

Requirement Reag. JP method Reag. USP (ACS) method Reag. EP method FUJIFILM Wako Guaranteed
1 Description Clear, colourless liquid Clear, colourless liquid Clear, colourless liquid Clear, colourless liquid
2 Density (20 ℃) - - 0.78 g/mL 0.780 ~ 0.783 g/mL
3 Refractive index nD20 - - 1.344 1.343 ~ 1.346
4 Absorbance 200 nm: max. 0.07
210 nm: max. 0.046
220 nm: max. 0.027
230 nm: max. 0.014
240 nm: max. 0.009
190 nm: max. 1.00
220 nm: max. 0.05
254 nm: max. 0.01
200 nm: max. 0.10 (EP-R1) 200 nm: max.0.05 (JP)
210 nm: max. 0.03 (JP)
220 nm: max. 0.02 (JP)
230 nm: max. 0.01 (JP)
240 nm: max. 0.005 (JP)
190 nm: max. 1.00 (USP)
220 nm: max. 0.05 (USP)
254 nm: max. 0.01 (USP)
5 Water - 0.3 % - max. 0.05 %
6 Residue after evaporation - 0.005 % - max. 0.001 %
7 Titrable acid - max. 8 μeq/g - max. 8 μeq/g
8 Assay min. 99.8 % (cGC)* min. 99.5 % min. 99.9 % (EP-R1)
min. 99.8 % (EP-LC)
min. 99.9 %
9 Titrable base - max. 0.6 μeq/g - max. 0.6 μeq/g
10 Color (APHA) - max. 10 - max. 10
11 Gradient elution - to pass test - to pass test
12 pH of a 100 g/L solution - - Neutral to litmus paper Neutral to litmus paper
13 Distillation range (80 - 82 ℃) - - min. 95 % min. 95 %
14 Absorbance (255 - 420 nm) - - min. 98 % min. 98 %
15 Absorbance (240 nm) - - min. 98 %(EP-LC) min. 98 %(EP-LC)
16 Ammonium (NH4) - - - max. 0.3 ppm*
17 Peroxides (as H2O2) - - - max. 5 ppm*
18 Substances reducing permanganate - - - to pass test*
19 Fluorescence test - - - to pass test*

*Additional specification by FUJIFILM Wako

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

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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