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Scopolamine Hydrobromide
Scopolamine, also known as hyoscine or Devil's Breath is a natural or synthetically produced tropane alkaloid and anticholinergic drug that is formally used as a medication for treating motion sickness and postoperative nausea and vomiting. It can also be used orally and as a transdermal patch. Scopolamine is on the World Health Organization's List of Essential Medicines.​
Technical Data Specifications
CAS No
Mol. Weight
6533-68-2
438.31
DMF Status
ACTIVE - Type II USDMF 7415 : Scopolamine Hydrobromide
ACTIVE - Type I (Health Canada) : Scopolamine Hydrobromide
ANALYSIS
DESCRIPTION
IDENTIFICATION A:
IDENTIFICATION B:
IDENTIFICATION C:
SPECIFICATION
White, crystalline powder, colourless
Infrared absorption
Yellow/ Brown colour
Retention time of the Scopolamine peak corresponds to the Standard Solution (Assay)
ASSAY:
98.0% - 102.0%
ORGANIC IMPURITIES:
Tropic Acid
Norscopolamine
Hyoscyamine
Apohyoscine
Apoatropine
Other NMT
Total Impurities NMT 0.7 %
NMT 0.20%
NMT 0.5 %
NMT 0.20%
NMT 0.20%
NMT 0.20%
0.10%
METHOD
Visual
Current USP monograph
Current USP monograph
Current USP monograph
Current USP monograph
Current USP monograph
RESIDUE ON IGNITION:
OPTICAL ROTATION:
pH (of a 5% w/v soln):
WATER DETERMINATION:
RESIDUAL SOLVENTS:
NMT 0.1%
-24º TO -26º
4.0 - 5.5
NMT 13.0%
Complies with Class 2 Solvents: < 60ppm
Current USP monograph
Current USP monograph
Current USP monograph
Current USP monograph
Current USP monograph
Products are manufactured according to the ICH GMP Guide for APIs
Products are manufactured under Phytex Australia GMP License (Australian Therapeutic Goods Administration (TGA))
Download the specification sheet
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