连 云 港 贵 科 药 业 有 限 公 司

L I A N Y U N G A N G G U I K E P H A R M A C E U T I C A L C O . , LT D

Specification of Atracurium Besylate

CAS No. [64228-81-5]

According To USP43

TEST SPECIFICATION

Appearance White to yellowish-white powder.

Soluble in water, very soluble in acetonitrile, in ethanol (96 per cent) and in
Solubility
methylene chloride.
Heavy Metals NMT 20ppm

(1) IR
(2) The retention times of the three main isomeric peaks of the Sample solution
Identification
correspond to those of the Standard solution, as obtained in the Assay.

(1) Impurity E: NMT1.5%

(2) Impurity F: NMT1.0%

(3) Impurity G: NMT1.0%

(4) Impurity D: NMT1.5%

(5) Impurity A: NMT1.5%

(6) Impurity I: NMT1.0%

Related substances
(7) Impurity H: NMT1.0%

(8) Impurity K: NMT1.0%

(9) Impurity B: NMT0.1%

(10) Impurity C: NMT1.0%

(11) Any other impurity: NMT 0.1 %

(12) Total impurities: NMT3.5%

Impurity J NMT 100ppm

(1) Atracurium cis-cis isomer: 55.0% ~ 60.0%

Isomer composition (2) Atracurium cis-trans isomer: 34.5% ~ 38.5%

(3) Atracurium trans-trans isomer: 5.0% ~ 6.5%

Water NMT 5.0%

Residue on ignition NMT 0.2%

地址: 中国江苏连云港经济技术开发区大浦工业区先锋路 1 号 邮编:222000

No.1, Xianfeng Road, Dapu Industrial Park, Lianyungang Economic & Technological Development Zone,
Lianyungang (222000), Jiangsu, China
www.guikepharm.com
 连 云 港 贵 科 药 业 有 限 公 司
L I A N Y U N G A N G G U I K E P H A R M A C E U T I C A L C O . , LT D

Specification of Atracurium Besylate

CAS No. [64228-81-5]

According To USP43

TEST SPECIFICATION

Assay 96.0% ~ 102.0%(anhydrous substance)

(1) Dichloromethane: NMT 600ppm

(2) Acetonitrile: NMT 410ppm

Residual Solvents (3) Ethyl ether: NMT 5000ppm

(4) Toluene: NMT 890ppm

(5) Acetone:NMT5000ppm

Bacterial endotoxin NMT3.0EU/mg

地址: 中国江苏连云港经济技术开发区大浦工业区先锋路 1 号 邮编:222000

No.1, Xianfeng Road, Dapu Industrial Park, Lianyungang Economic & Technological Development Zone,
Lianyungang (222000), Jiangsu, China
www.guikepharm.com