Product Name

L-Leucovorin Calcium

CAS No

80433-71-2

Catalog No

SC-16190

Quantity

1Kg

Batch No

20160801

Product Date

2016.08.01

Date of analysis

2016.08.01

Items of analysis

Specification

Results

Appearance

White or light yellow amorphours or crystalline Powder,hpgroscopic,slightly soluble in water

Conforms

PH of solution(0.8%in water)

7.5-8.5

7.7

Specific optical rotation(on anhydrous basis

-10.0°to-15.0°

-11.0°

Water content

10.0%-17.0%

13.6%

Related substances

Impurity H

NMT0.5%

Not Detected

Any other impurity

NMT0.8%

0.09%

Total impurities

NMT1.0%

0.6%

Chlorides

NMT0.5%

＜0.5%

Heavy metals

NMT50ppm

＜50ppm

Assy(on anhydrous basis)

Calcium

7.54%-8.14%

7.78%

Calcium folinate

97%min

100.3%

Residual solvents

Ethanol

NMT30000ppm

20222ppm

Acetone

NMT5000ppm

266ppm

Bacterial endotoxins

NMT0.5EU/mg

＜0.5EU/mg

Remark

Declaration: For laboratory use by technically qualified individual only

Conclusion

It accords with the Enterprise Standard