Items

Standard Result

 Result

Appearance

White or off-white solid

White solid

Identification

HPLC

The retention time of the major peak of the Sample solution corresponds to that of the  Standard solution, as obtained in Assay.

Conform

Specific optical rotation [ a]D 20.

6 - 10

8.2

Solubility

Freely soluble in dimethyl

sulfoxide ,sparingly soluble in water , practically in soluble in acetone .

Conform

Solution clarity and colour

Solution should be clear and colorless , if not comparing with Reference suspensions it

should be not thicker .

Conform

pH

6.5-8.5

6.9

Water

≤0.5 %

0.19%

Residual Solvents 1

Methanol ≤3000ppms

Acetonitrile≤410ppms

Ethanol≤5000ppm

371 ppm

Not Detected

Not Detected

Residual Solvents 2

Dimethyl sulfoxide ≤5000ppm

1610 ppm

Related Substances 1

Impurity A ≤0.15 %

Impurity D≤0.15 %

Impurity E≤0.15 %

Impurity F≤0.15 %

Impurity H≤0.15 %

Impurity M≤0.15 %

Impurity N≤0.15 %

Unspecified impurities ≤0.10 %

0.005%

0.02%

0.04%

Not Detected

Not Detected

0.01%

Not Detected

0.05 %

Related Substances 2

Impurity C≤0.3 %

Impurity G≤0.15 %

Impurity K≤0.15 %

0.05 %

Not Detected

Not Detected

Total impurities

Sum of Related Substances land 2 ≤1.0 %

0.23%

Bacterial Endotoxins

< 0.3 EU / mg

Conform

Size detection

Pass rate of 60 mesh

≤80%

79%

No hard particles in the failed part

Conform

Microbial Enumeration

Total aerobic microbial count

≤100 cfu / g

< 1 cfu / g

Total molds and yeasts

≤10 cfu / g

< 1 cfu / g

Assay

98 0% - 102.0%

101.1%