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CAS NO.149-64-4
1(0-1)Kilogram1(1-10)Kilogram
HYOSCINE BUTYLBROMIDE/ butylbromide
1.package : 1kg/bottle
2.purity 99%
HYOSCINE BUTYLBROMIDE/butylbromide
1. Pharmceutical material for peripheral anticholinergic drugs which can smooth muscle spasm , ease the gastrointestinal tract , bile duct and urinary tract and inhibit peristalsis .
2 .It applies to the stomach, duodenum ,colon fiber endoscopic examination as the operative preparation.
3. It can be used for the treatment of gastrointestinal spasm,biliary Colic,renal colic or gastrointestinal peristalsis, such as hyperthyroidism
the COA of HYOSCINE BUTYLBROMIDE/ 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 |
|
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Related substance
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Total impurities<1.0% |
0.83% |
/ |
|
Unidentified impurity<0.1% |
0.08% |
/ |
|
|
(-)-hydrobromide≤0.1% |
0.05% |
/ |
|
|
N-butyl Nonscopolamine bromide<0.2% |
0.07% |
/ |
|
|
(-)-propylbromide<0.2% |
0.08% |
/ |
|
|
(-)- methylbromide<0.2% |
0.15% |
/ |
|
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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 |
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|
|
Conclusion |
The results conforms with BP standards |
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