Jinan Hongfangde Pharmatech C o., Ltd

Product name

Vecuroniu Bromide

Batch No.

20170301

CAS NO

50700-72-6

Report Date

2017.03.15

Expiry date

2019.02

Inspection   Items

Accepted Standard

Results

Appearance

White or almost white crystals crystalline   powder

Complies

Identification

1.       By IR, To match with working   standard

Complies

2.       Specific optical rotation

Complies

3.    It gives a reaction of bromides

Complies

Solubility

Slightly soluble in water and acetone，

sparingly soluble in  alcohol.

Complies

Appearance   of the sloution

The solution is   clear and not more intensely coloured than reference solution BY7

Complies

Specific optical   rotation

+30.5° ～ +35.0°

+33.2°

Loss on drying

≤4.0%

1.37%

Related substance  

Impurities A ≤0.25%

0.09

Impurities C≤0.25%

Complies

Impurities D≤0.25%

0.48%

Impurities E≤0.25%

0.13%

Impurity B: ≤0.25%

Complies

Unspecified impurity: for each impurity   ≤0.10%

Complies

Total impurity: ≤0.70%

0.55%

Residue on ignition

≤0.1%

0.08%

Endotoxin

≤10EU/mg

8

Residual solvents

Methylene   chloride ≤600ppm

Complies

Methanol≤3000ppm

Complies

Acetone   ≤5000ppm

Complies

Assay

99.0%～101.0%

99.61%

Conclusion   ：Complies to   the EP8.0