GMP Certified High Quality Rocuronium Bromide CAS 119302

Basic Info.

Model NO.	SAMREAL-RB-01
Standard	Ep, USP and Others
Transport Package	Bag
Specification	1kg/bag
Trademark	samreal
Origin	China
Production Capacity	100 Kg/Month

Product Description

119302-91-9 Rocuronium bromide EP10/USP42 standard

Items	Standards	Results
Appearance	Off-white to light yellow powder,hygroscopicity	Off-white powder, hygroscopicity
Solubility	Freely soluble in water,ethanol trichloromethane or glacial acetic acid,almost insoluble in ether	complied
Specific rotation	+28.5°to+32.0°	+30.9°
Identification
(1)	The retention time of test solution main peak should be accordance with system suitability test solution of Rocuronium Bromide peak.	complied
(2)	Identification reaction of bromide in aqueous solution of this product	complied
(3)	The infrared absorption of this product should be accordance with W.S spectrum	complied
Alkalinity	PH:8.9-9.5	9.3
Color and clarity of solution	The solution should be colorless and clarified;If it appears color,should not be stronger than yellow or orange yellow No.2 standard colorimetric solution.	complied
Acetic acid	Not more than 0.5%	N.D
3-Bromopropene	If there are chromatographic peaks with the same retention time as the main peak of the control solution,the peak area should not more than the main peak area of the reference solution(0.0005%)	N.D
Related substances	Impurity A not more than 0.1%	N.D
	Impurity B not more than 0.2%	0.06%
	Impurity C not more than 0.2%	0.01%
	Impurity F not more than 0.1%	0.01%
	Impurity G not more than 0.1%	N.D
	Impurity H not more than 0.1%	N.D
	Other single impurity not more than 0.10%	N.D
	Total impurities should be not more than 1.0%	0.087%
Residual solvents	Methanol not more than 0.3%	N.D
	Ethyl ether not more than 0.5%	0.2%
	Acetone not more than 0.5%	0.004%
	Acetonitrile not more than 0.041%	N.D
	Dichloromethane not more than 0.06%	N.D
	Methyl tert-butyl ether not more than 0.5%	0.02%
Triethylamine	Not more than 0.032%	N.D
Water content	Not more than 3.5%	1.8%
Residue on ignition	Not more than 0.1%	0.06%
Heavy metal	Not more than 10ppm	complied
Bacterial endotoxin	Endotoxin amount per 1mg Rocuronium Bromide should be less than 0.3EU	complied
Assay(calculate by anhydrous&solvent-free substances)	99.0%-101.0%	100.7%
Conclusion	This product is tested by Rocuronium Bromide(For export)quality standard(STP-11-338-01). The results comply with(√Yes No). The results comply with EP10.0 Rocuronium Bromide quality standard.

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