Hyoscine butylbromide

Item

Specifications

Results

Method

Basic Product Information

Assay

>99-101.0%

100.2%

HPLC

Organoleptic Data

Appearance

White crystalline powder

Conform

NLS-QCS-1008

Odor

Characteristic

Conform

GB/T 5492-2008

Solubility 

Freely soluble in water, and methylene chloride, sparingly soluble in ethanol.

Conform

Identification

Examine by IR, consistent with the chemical reference substance.

Gives the reaction of tropane alkaloids. 

Gives the reaction of bromides.

Should comply Specific rotation test.

Conform

Melting point

139-141°C 

139-140°C

Specific Optical Rotation

(100mg/ml soluble in

 water at 25°C)

-18°~-20° (H2O)

-18.7(H2O)

PH(50mg/ml soluble in water)

5.5~6.5

5.53

Process Data

Related substance

Total impurities<1.0%

0.83%

/

Unidentified impurity<0.1%

0.08%

/

(-)-scopolamine hydrobromide≤0.1%

0.05%

/

N-butyl Nonscopolamine bromide<0.2%

0.07%

/

(-)-Scopolamine propylbromide<0.2%

0.08%

/

(-)-scopolamine methylbromide<0.2%

0.15%

/

Tropic acid<0.2%

0.13%

/

Apo-N-Hyoscine butylbromide<0.2%  

0.16%

/

Physical Characteristics

Loss on Drying

2.5%

0.87%

GB/T 14769-1993

Residue on Ignition

<0.1%

Conform

AOAC 942.05,18th

Heavy Metals

Total Heavy Metals

<20ppm

Conform

USP<231>,method11

As

<2ppm

Conform

Pesticides

Negative

Negative

Residual Solvents

Methanol<100ppm

Conform

Ethanol<100ppm

Conform

Conclusion

The results conforms with BP standards