ITEMS

SPECIFICATION

RESULTS

Appearance

White or almost white ,crystalline powder or colorless crystal

White crstalline powder

Solubility

Freely soluble in water ,soluble in ethanol 96%,insoluble in methylene chloride.

Complies

Identification A

Melting point: between 118°~ 122°

119°~ 120°

Identification B

IR chromatogram

Complies

Identification C

TLC chromatogram

Complies

Identification D

Copper sulfate test

Complies

Identification E

Cholride reaction

Complies

 Acidity or Alkalinity

Complies

Complies

Appearance of solution

Clear and colorless

Complies

Specofoc optical rotation

-0.1° ~ +0.1°

0.0°

Related substances

Impurity A ≤ 0.4%

Not detected

Impurity B ≤0.2%

0.02%

Impurity C ≤0.2%

Not detected

Impurity D ≤0.2%

Not detected

Impurity E ≤0.2%

Not detected

Any oter impurity ≤ 0.1%

0.06%

Sum of the impurities other than A ≤ 1.0%

0.11%

Sulphates

Not more than 200ppm

Complies

Heavy Metals

Not more than 20ppm

Complies

Loss on drying

Not more than 0.5%

0.05%

Sulphated ash

Not more than 0.1%

0.08%

Assay

98.0 ~ 101.0%

99.3%

Endotoxin parameter

≤ 2.5EU/MG

＜0.001EU/MG

Residual solvents

Methanol ≤ 3000ppm

300ppm

Isopropanol ≤ 5000ppm

3000ppm

Ethanol ≤5000ppm

Not detected

Package and storage

Preserve in tight and light-resistant containers

Conclusion: The product complies with EP8.0 standard