Calcium folinate

Test Items

Test Standard

Appearance

A white or light yellow, amorphous or crystalline powder

Identification

1. Specific optical rotation

+14.4°~+18.0°

1. IR

Should conform

1. TLC

Should conform(in ultraviolet light at 254 nm)

1. Calcium

Should conform

Test

Appearance of solution

Solution is clear. The absorbance of solution, measured at 420 nm using water R as the compensation liquid, is not greater than 0.60

Chloride

≤0.5%

Individual Impurity

≤1.0%

Total Impurity

≤2.5%

Methanol

≤0.5%

Ethanol

≤3.0%

Acetone

≤0.5%

Bacterial Endotoxins

≤0.51U/mg

PH

6.8~8.0

Heavy Metals

≤50ppm

Water

≤17.0%

Platimun

≤20ppm

Assay of Ca

7.54%~8.14%

Assay(anhydrous substance)

97.0%~102.0%

Test conclusion: This test results comply with the requirement of EP7.0 edition.