Items of Test

Limits of Test

Results of Test

1.Appearance

Orange yellow crystalline powder(USP)

Meets

2.Indentification

Positive

Meets

3.Acidity or Alkalinity

Check the color of the test solution

After adding the respective solutions

Meets

4.Lumiflavin

Absorbance of the filtrate at 440nm

Does not exceed 0.025(USP);not

 more intense than BY6(EP/BP)

0.009

Meets

5.Absorbance

0.31 – 0.33 A375nm/A267nm

0.36 – 0.39 A444nm/A267nm

0.32/0.38

6. Partical Size

100%passes through 60 mesh sieve

Meets

7. Specific Rotation

between-115°and-135°(EP/BP/USP)

121°(USP)

129°(EP/BP)

8.Loss on Drying

≤1.5%

0.8%

9. Heavy Metals

<10ppm

Meets

10. Residue on Ignition

≤0.03%(USP)

≤0.1%(EP/BP)

0.1%

11.Organic Volatile Impurities

Method IV<467>(USP)

Meets

12. Assay(on dried basis)

98.0% - 102.0%(USP)

97.0% - 10.3.0%(EP/BP)

99.6%