Development of Karl Fischer Reagents

2. Japan Pharmaceutical Codex (Revision 14)
Chapter I: Basic Knowledge
General Test Method 27: Moisture Content Test (Karl Fischer Method)
The items listed in the Pharmaceutical Codex that stipulate the use of
moisture content testing by means of Karl Fischer reagent are as follows.
Item Tolerance (sample amount)
Aspirin aluminum 4.0% (0.15g)
Aminophylline 7.9% (0.3g)
Isopropanol 0.7%w/v (2ml)
Quinine ethylcarbonate 3.0% (0.5g)
Ethosuximide 0.5% (2g)
Suxamethonium chloride 8.0-10.0% (0.4g)
Suxamethonium chloride for injection 10.0% (0.4g)
Berberine chloride 15.6% (0.3g)
Benzalkonium chloride 15.0%
Thiamine hydrochloride 5.0% (0.5g)
Anhydrous citric acid 0.5% (2g)
Clofibrate 0.2% (5g)
Cyclophosphamide 5.5-7.0% (0.5g)
Distigumine bromide 1.0% (1g)
Dextromethorphan hydrobromide 4.0-5.5% (0.2g, back titration)
Isosorbide dinitrate 1.5% (0.3g)
Hydroxyzine pamoate 3.0% (1g)
Potassium guaiacolsulfonate 3.0-4.5% (0.3g)
Metothrexate 12.0% (0.2g, special method)
Mercaptopurin 10.0-12.0% (0.2g, back titration)
Folic acid 8.5% (0.2g, special method)
Riboflavin sodium phosphate 10.0% (0.1g, back titration)
Protirelin tartrate 4.5% (0.2g)
Terbutaline sulfate 0.5% (1g)
Chlorobutanol 6.0% (0.2g)
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