Item # EB0280-103-09
DESCRIPTION: The product is an alkaloid extracted from the tuberous plant Leucojum aestivum L. from the Amaryllidaceae family. It is manufactured as galanthamine hydrobromide. Galanthamine bromide substance is used in the manufacturing of the medication Nivalin, which is a strong (reversible) cholinesterase inhibitor, increasing the susceptibility of the organism to acetylcholine.
It facilitates the transmission of impulses in neuromuscular synapses and restores neuromuscular transmission. The drug crosses the hematoencephalic barrier and in proper doses facilitates the transmission in the synapses of the central nervous system, and enhances the excitation processes. It enhances the tone of the smooth muscles and intensifies the secretion of the gastric and sweat glands.
MOLECULAR MASS: 368.28 (hydrobromide) and 287.36 (base)
PHYSICO-CHEMICAL INDICES OF THE FINISHED PRODUCT
| ¤ Appearance | Fine crystalline powder |
| ¤ Color | White or almost white |
| ¤ Odor | None |
| ¤ Solubility | |
 in water |
Poorly soluble |
| in 95% alcohol |
Practically insoluble |
| in chloroform |
Practically insoluble |
| in ether |
Practically insoluble |
| ¤ Specific rotation [α] 20D solution with concentration of 2.0 g/100 ml (°) | From -90.0 to -100.0 |
| ¤ Sulphates content (mg/g) | Not more than 1.0 |
| ¤ Sulphate ash (%) | Not more than 1.0 |
| ¤ Heavy metal content (mg/g) | Not more than 20.0 |
| ¤ Weight loss on drying (mg/g) | Not more than 10.0 |
| ¤ Galanthamine bromide content (%) | |
| Calculated as dry substance |
98.0 - 100.5 |
| ¤ Microbial content | |
| Total microorganisms
(number/g) |
Not more than 10 -3 |
| Moulds and yeast (number/g) |
Not more than 10 -2 |
| Enterobacteriaceae, Ps.
Aeruginosa, St. aureus |
Not allowed |
SUPPLIED: The substance is filled in polyethylene bags of 2 kg and placed in cardboard barrels.
QUALITY: Bulgarian State Standard
EXPIRY: 5 YEARS
MEDICINAL FORM AND PACKAGE:
NIVALIN original Bulgarian patented medicine
- Ampoules of 1 mg/ml; 2.5 mg/ml; 5 mg/ml and 10 mg/ml in packs of 10, 50 and 100
- Syrup of o.5 mg/ml in bottles of 125 ml
- Tablets of 1 mg and 5 mg in packs of 50 and 10 mg in packs of 20.