Item

Specifications 

   Result

Appearance

White or almost white powder

Off white powder

Indentification

HPLC:The retention time of principle peak obtained from 

Test solution should conform with that obtained from 

Standard solution, as test in Assay

Conforms

IR: Spectrum of Test sample should conform to that 

of Caspofungin Acetate Reference Standard

Conforms

Specific Optical Rotation

-102.0°~108.0 °

-105.3°

PH

5.0~7.0

6.5

Water

10.0%

7.5%

Solution color and clarity

Solution should be clear colorless

Conforms

Related substances I

Impurity A:  NMT 0.10%

ND

Impurity B:  NMT 0.10%

ND

Impurity D:  NMT 0.30%

0.17%

Impurity E:  NMT 0.10%

ND

Unspecified impurity F:  NMT 0.10%

0.03%

Unspecified impurity G:  NMT 0.10%

ND

Pneumocandin B0: NMT 0.10%

ND

Each of unspecified impurity : NMT 0.10%

0.04%

Total impurity:  NMT 1.0%

0.24%

Related substances II

Impurity C: NMT 0.10%

0.03%

Acetic acid

9.0%~11.0%(calculated on anhydrous basis)

10.1%

Heavy Metal as Pb

NMT 10ppm

Conforms