Items of Test

Limits of Test

Results of Test

1.Appearance

Orange yellow crystalline powder

Meets

2.Identification

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)

0.008

Meets

5.Absorbance

0.31-0.33 A373nm/A267nm

0.36-0.39 A444nm/A267nm

0.32

0.38

6.Particla Size

100% passes through 60 mesh sieve

Meets

7.Specific Rotation

between-115º and -135º

(EP/BP/USP)

-121º(USP)

-1300(BP/EP)

8.Loss on Drying

≤1.5%

0.4%

9.Heavy Metals

<10ppm

Meets

10.Residue on Ignition

≤0.3% (USP)

≤0.1%(EP/BP)

0.1%

11.Residual Solvents

Method IV <467>

(USP)

Meets

12.Assay(ondried basis)

98.0%-102.0% (USP)

97.0%-103.0% (EP/BP)

98.8%(USP)

99.7%(EP/BP)

CONCLUSION: The product with this batch number meets all requirements of the

following valid compendia when tested accordingly: EP5+BP2008+ USP33.