Batch No.:

20201102

Date of Manufature

2020.11.02

Batch Size

30kg

Certificate Date

2020.11.02

Specification

EP Ⅳ

Date of Expiry

2022.11

Test

Specification

Results

Appearance

White to brownish-yellow,fine,crystalline powder

Complies

Solubility

Sparingly soluble in water , slightly soluble in Methanol , very slightly soluble in acetonifrile

Complies

Identification

TLC

Complies

IR spectrum

Complies

Clarity and colour of solution

Clear and not more than Y₄BY₄B₄

＜BY₄

Loss on drying

Not more than 0.5%

0.20%

Sulphated ash

Not more than 0.1%

0.02%

Related substances(HPLC)

Impurity A

Impurity G

Single unknown impurity

Total impurities

Not more than 0.2%

Not more than 0.2%

Not more than 0. 15%

Not more than 0.5%

N.D

0.07%

N.D

0.07%

Residual solvents

Acetone≤5000ppm

Methanol≤500ppm

1750ppm

＜1ppm

Assay(potetiometic titration)

Calculated on the dried basis

Between 98.5% and 101.0%

99.55%

Conclusion

Complies