|
TEST ITEMS |
SPECIFICATION |
RESULT |
|
Appearance |
Yellow-white or yellow powder |
Yellow-white powder |
|
Identification |
||
|
HPLC |
The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the Assay |
Conforms |
|
Calcium |
Produce calcium reacts. |
Conforms |
|
IR |
IR absorption spectrum of sample is similar with reference standard. |
Conforms |
|
Heavy Metals |
NMT 50ppm |
Conforms |
|
Water Content |
NMT 17.0% |
11.5% |
|
Assay (on anhydrous basis) |
95.0%～105.0% |
99.4% |
|
Related substances |
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|
5-Formyl-5,6,7,8-tetrahydrop- teroic acid |
NMT 0.5% |
0.3% |
|
4-Aminobenzoylglutamic acid |
NMT 1.5% |
0.1% |
|
10-Formyldihydrofolic acid |
NMT 1.0% |
0.1% |
|
5,10-Diformyltetrahydrofolic acid |
NMT 1.5% |
Not Detected |
|
7,8-Dihydrofolic acid |
NMT 0.5% |
Not Detected |
|
10-Formylfolic acid |
NMT 0.5% |
0.1% |
|
Folic acid |
NMT 1.5% |
Not Detected |
|
Unspecified impurity |
NMT 0.3% |
0.1% |
