|
|
|
|
|
|
|
|
|
|
-
|
purity(D-isomer)(HPLC)
|
-
|
≤1.0%
|
-
|
<0.5%
|
|
|
|
-
|
Appearance
|
-
|
Cream to light brown powder
|
-
|
Cream powder
|
|
|
|
-
|
(6s)-5-Methyltetrahydrofolicacid assay(HPLC)
|
-
|
54.0 to 59.0% on anhydrous basis
|
-
|
57.80%
|
|
|
|
-
|
Glucosamine assay(HPLC):
|
-
|
34.0 to 46.0% on anhydrous basis
|
-
|
38.40%
|
|
|
|
-
|
Specific Rotation(C=2.0%in water,25℃)
|
-
|
﹢53.0°～﹢59.0°
|
-
|
﹢56.8°
|
|
|
|
-
|
pH (1%w/v aqueous solution)
|
-
|
5.5-6.5
|
-
|
6.2
|
|
|
|
-
|
Residual solvent
|
-
|
Ethanol:≤0.2%
|
-
|
<0.05%
|
|
|
|
-
|
Water
|
-
|
≤8.0%
|
-
|
4.3%
|
|
|
|
-
|
Platinum(Pt)
|
-
|
≤10mg/kg
|
-
|
<1.0 mg/kg
|
|
|
|
-
|
Lead(Pb)
|
-
|
≤0.5mg/kg
|
-
|
0.13 mg/kg
|
|
|
|
-
|
Lead(Pb)
|
-
|
≤1.0mg/kg
|
-
|
<0.01mg/kg
|
|
|
|
-
|
Arsenic(As)
|
-
|
≤3.0mg/kg
|
-
|
<0.1 mg/kg
|
|
|
|
-
|
Mercury(Hg)
|
-
|
≤0.1mg/kg
|
-
|
<0.01 mg/kg
|
|
|
|
-
|
Boron(B)
|
-
|
≤50mg/kg
|
-
|
<5.0 mg/kg
|
|
|
|
-
|
Total plate count
|
-
|
≤1000cuf/g
|
-
|
<10 cuf/g
|
|
|
|
-
|
Mold & Yeasts
|
-
|
≤100cuf/g
|
-
|
<10 cuf/g
|
|
|
|
-
|
Mold & Yeasts
|
-
|
Negative
|
-
|
Negative
|
|
|
|
-
|
E.Coli.
|
-
|
Negative
|
-
|
Negative
|
|
|
|
-
|
Individual organic impurity (known)
|
-
|
≤1.0%
|
-
|
Conforms
|
|
|
|
-
|
Total organic impurity
|
-
|
≤2.5%
|
-
|
Conforms
|
|
|
|
-
|
Diastereoisomeric purity
|
-
|
≥99.0% of (6s)-5-methyltetrahydrofolic acid
|
-
|
99.12%
|
