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ICH-Harmonized Reagents for Medicine Test



These reagents for pharmaceutical testing are compliant with the reagent specifications of three major pharmacopoeias (Japanese Pharmacopoeia, United States Pharmacopeia [USP], and European Pharmacopoeia [EP]). We have released 22 new reagents for general medicine test. They will help testing of pharmaceutical products developed for global markets.

INDEX

  1. Certified Specifications

  2. Product List

  3. Certified Characteristics

  4. Related Products
    ♣ ICH-Harmonized Solvents for Liquid Chromatography
    ♣ Standard Solutions for Volumetric Analysis, compliant with Japanese Pharmacopoeia


1. Certified Specifications
  • Japanese Pharmacopoeia (JIS special grade reagent)
  • Reagents USP (ACS Specification)
  • Reagents EP


2. Product List
Product Name Certified Specifications Package Size Wako Catalog No. Grade
Acetic Acid JIS, ACS, Reag. EP 500 mL 012-23325 for Medicine Test
Acetic Acid Anhydride JIS, ACS, Reag. EP 500 mL 019-23335
Acetone JIS, ACS, Reag. EP 500 mL 016-23345
Ammonia Solution JIS, ACS, Reag. EP 500 mL 016-23345
Diammonium Hydrogen Citrate JIS, ACS, Reag. EP 500 g 044-31615
Diethyl Ether* JIS, Reag. EP 500 mL 047-31605
N,N-Dimethylformamide JIS, ACS, Reag. EP 500 mL 048-31635
Disodium Hydrogenphosphate 12-Water JIS, Reag. USP, Reag. EP 500 g 041-31505
Ethyl Acetate JIS, ACS, Reag. EP 500 mL 053-08155
Ethanol (95) JIS, Reag. USP, Reag. EP 500 mL 055-08095
Ethanol (99.5) JIS, ACS, Reag. EP 500 mL 058-08085
Hydrochloric Acid* JIS, Reag. EP 500 mL 084-09205
Methanol* JIS, Reag. EP 500 mL 084-09205
Potassium Dihydrogenphosphate JIS, ACS, Reag. EP 500 g 084-09205
Potassium Hydrate JIS, ACS, Reag. EP 500 g 160-24815
2-Propanol* JIS, Reag. EP 500 mL 160-24795
Sodium Acetate JIS, ACS, Reag. EP 500 g 198-15965
Sodium Acetate Trihydrate JIS, ACS, Reag. EP 500 g 198-16065
Sodium Chloride JIS, ACS, Reag. EP 500 g 198-16065
Sodium Hydrate JIS, ACS, Reag. EP 500 g 192-15985
Sulfuric Acid* JIS, Reag. EP 500 mL 199-15995
Toluene JIS, ACS, Reag. EP 500 mL 203-18465
*Compliant with two major pharmacopoeias (Japanese Pharmacopoeia and Reagents EP). We may provide test results with Reagents USP (only on some test items).

QUOTATION REQUEST for reagents for Medicine Test
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3. Certified Test Items (Example: Acetone)
Test Items Japanese Pharmacopoeia
(JIS Special Grade)
Reag. USP (ACS) Reag. EP
Assay (CH3COCH3) min. 99.5%
in weight percentage
min. 99.5% -
Appearance Colorless clear liquid * - -
Color (APHA)
(USP-NF method)
- max. 10 -
Non-volatile Residue
(Residue on evaporation)
(EP method)
max. 5 ppm
in weight percentage
max. 0.001% max. 50 ppm
Solubility in Water (water-insoluble matter)
(USP-NF method)
to pass test to pass test to pass test
Titrable Acid
(USP-NF method)
max. 0.002%
in weight percentage
max. 0.0003 meq/g to pass test
Titrable Base
(USP-NF method)
max. 0.001%
in weight percentage
max. 0.0006 meq/g to pass test
Aldehyde (as HCHO)
(USP-NF method)
max. 0.002%
in weight percentage
max. 0.002% -
Isopropyl Alcohol
(USP-NF method)
- max. 0.05% -
Methanol
(USP-NF method)
max. 0.05%
in weight percentage
max. 0.05% -
Related Substances
(EP method)
- - to pass test
Substances reducing permanganate
(USP-NF method)
max. 2%
in weight percentage
to pass test to pass test
Water (H2O)
(USP-NF method)
max. 0.3%
in weight percentage
max. 0.5 max. 3 g/L
Refractive Index nD20 1.358-1.360 - -
Density (relative) 0.789-0.792g/ml - 0.790~0.793
* Wako original added specification

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4. Related Products

     ♣ ICH-harmonized Solvents for Liquid Chromatography
         Following products are compliant with the reagent specifications of the Japanese Pharmacopoeia, USP, and EP.

Product Name Package Size Wako Catalog No. Grade
Acetonitrile 1 L 019-21691 for General Tests
of the Japanese Pharmacopoeia
(for Liquid Chromatography)
3 L 015-21693
Methanol 1 L 136-15661
3 L 132-15663
Hexane 1 L 085-08711
3 L 081-08713

     ♣ Standard Solutions for volumetric analysis, compliant with Japanese Pharmacopoeia
         Following products are compliant with the standards specified in "General Tests, Processes and Apparatus" of the
         Japanese Pharmacopoeia.

Product Name Package Size Wako Catalog No. Grade
1 mol/L Hydrochloric Acid 500 mL 162-21195 for Volumetric Analysis
(Standardized to JP General Tests)
0.02 mol/L Potassium Permanganate Solution 500 mL 162-21195
0.1 mol/L Sodium Hydroxide Solution 500 mL 197-13095
1 mol/L Sodium Hydroxide Solution 500 mL 190-13085
0.05 mol/L Sulfuric Acid 500 mL 190-13105
*Each product is not for in vitro diagnostic use.
QUOTATION REQUEST for reagents for Medicine Test
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Note

  • Listed products are intended for laboratory research use only, and not to be used for drug, food or human.
  • Please visit our online catalog to search for other products from Wako: http://www.e-reagent.com
  • This information may contain products that cannot be exported to your country due to regulations.
  • Bulk quote requests for some products are welcomed. Please contact us or our distributor near you.

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