Vonoprazan fumarate is a first-in-class potassium-competitive acid blocker. It was approved in the Japanese market in February 2015.
Vonoprazan can be used for the treatment of gastroduodenal ulcer (including some drug-induced peptic ulcers) and reflux esophagitis, and can be combined with antibiotics for the eradication of Helicobacter pylori.
Product Description:
Product name | Vonoprazan fumarate |
CAS NO. | 881681-00-1 |
Synonyms | Vonoprazan fumarate |
Category | Pharmaceutical Raw Materials,Active Pharmaceutical Ingredients,Bulk Drugs,Fine Chemicals. |
Standard | purity:>99% |
Appearance | Vonoprazan fumarate powder |
Shelf life | 2 years |
Usage | Vonoprazan fumarate shows strong and sustainable acid secretion inhibitory effects as well as demonstrate efficacy in early termination by inhibiting the binding of potassium ion (K+) to H+, K+-ATPase (proton pump) in the final step of gastric acid secretion in gastric parietal cells. |
Storage | Vonoprazan fumarate should be stored in a well-closed container at low temperature, keep away from moisture, heat and light. |
Specification:
TEST | SPECIFICATION | RESULT |
Appearance | White to off-white crystals | White crystals |
Identification | 1-HNMR: Consistent with the standard | Conforms |
HPLC: The HPLC spectrum of the sample must be concordant with the standard substance. | Conforms | |
Ignition residue | NMT 0.1% | Conforms |
Heavy Metals | NMT 20ppm | N.D. |
Loss on drying | NMT 1.0% | 0.16% |
Related Substance | U2: NMT 0.2% | 0.03% |
U3: NMT 0.3% | 0.04% | |
U4: NMT 0.2% | N.D. | |
U6: NMT 0.5% | N.D. | |
U8: NMT 0.4% | N.D. | |
U9: NMT 0.25% | 0.04% | |
Any other impurity: NMT 0.15% | 0.05% | |
Total impurities: NMT 0.19% | 0.23% | |
Residual Solvents | Methanol: NMT 0.3% | N.D. |
Ethanol: NMT 0.5% | N.D. | |
Ethyl acetate: NMT 0.5% | N.D. | |
Assay(By HPLC) | 98.0%~102% | 99.78% |
Storage | Store in a tightly closed container in a cool and dry place, below 20℃. | |
Conclusion | Confirm to enterprise standard |
Packaging & Shipping:
Packaging:
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