Name

Atracurium besylate

Alias

CAS NO.

64228-81-5

Molecular Formula

C65H82N2O18S2

Molecular Weight

1243.48

Quality Standard

Current USP

Package Size

2kg or 3kg/tin/carton

Storage condition

Preserve in tight,light-resistant containers and store at 2-8℃

TEST

STANDARD

RESULT

Description

whiteto off-white powder,

White powder

Solubility

Very soluble in acetonitrile, in alcohol, and in methylene chloride; soluble in water

Conforms

Identification

A.IR spectrum of the sample should correspond to that of the Reference Standard

Conforms

B.The retention times of the three main isomeric peaks of the sample solution correspond to those of the standard solution, as obtained in the assay

Conforms

Water

NMT 5.0%

1.4%

Clarity and Color of Solution

The solution is clear and not more intensely colored than standard solution

Conforms

Residue on ignition

NMT 0.1%

0.06%

Heavy Metals

NMT 20ppm

＜20ppm

Impurity J

NMT 0.001%

＜0.001%

Related Substances

Impurity A(containing A1 and A2): Not more than 1.5%

0.48%

Impurity B: Not more than 0.1%

＜0.006%

Impurity C(containing C1 and C2): Not more than 1.0%

0.25%

Impurity D(containing D1 and D2): Not more than 1.5%

0.25%

Impurity E: Not more than 1.5%

＜0.05%

Impurity F: Not more than 1.0%

＜0.05%

Impurity G: Not more than 1.0%

0.09%

Total of Impurity H,I and K:Not more than 1.0%:

0.10%

Tetrahydropapaverine: Not more than 0.10%

＜0.05%

Any other individual impurity: Not more than 0.1%

＜0.05%

Total impurities: Not more than 3.5%

(Disregard any impurity less than 0.05%)

1.2%

Microbial Limit

Total aerobic bacteria: Not more than 100CFU/g

＜1cfu/g

Mold and yeast: Not more than 10CFU/g

＜1cfu/g

E. coli. :should be absent in each 1g

Non-detected

Bacterial Endotoxin

Not more than 2.0EU/mg

＜2.0EU/mg

Residue Solvents

Ether: Not more than 5000ppm

＜3ppm

Acetone: Not more than 5000ppm

＜8ppm

Ethylacetate:Not more than 5000ppm

＜16ppm

Dichloromethane: Not more than 600ppm

66ppm

Ethanol: Not more than 5000ppm

＜18ppm

Acetonitrile: Not more than 410ppm

10ppm

Toluene: Not more than 890ppm

73ppm

Assay

Contain 97.0% to 102.0% of C65H82N2O18S2on the anhydrous basis

98.3%

Trans-trans isomer:5.0%-6.5%

5.5%

Cis-trans isomer: 34.5%-38.5%

35.9%

Cis-cis isomer:55.0%-60.0%

58.6%

Conclusion

Confirms tocurrent USP standard.