Vonoprazan fumarate is a salt form of vonoprazan, which is the active pharmaceutical ingredient. It is primarily used for the treatment of acid-related gastrointestinal disorders, such as gastroesophageal reflux disease (GERD), gastric ulcers, and duodenal ulcers.
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Vonoprazan works by selectively and reversibly inhibiting the H+/K+-ATPase enzyme, commonly known as the proton pump, in the stomach's parietal cells. This inhibition reduces the production of gastric acid, leading to effective suppression of acid secretion.
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Item |
Standard Regulation |
Test Result |
|
Appearance |
Appearance |
White to off-white crystal or crystalline powder |
Off-white crystalline powder |
Analysis |
Fluorine check |
3.9%-4.3% |
4.2% |
Chlorides |
Not more than 0.05% |
Complies |
|
Ammonium salt |
Not more than 0.05% |
Complies |
|
Sulfate |
Not more than 0.05% |
Complies |
|
Water |
Not more than 0.40% |
Complies |
|
Residue on Ignition |
Not more than 0.10% |
0.021% |
|
Heavy metals |
Not more than 20ppm |
Complies |
|
Organic Impurities |
Single impurity: not more than 0.15% |
0.062% |
|
Total impurity: not more than 1.0% |
0.25% |
||
Residual Solvents |
Methanol: not more than 0.30% |
Not detected |
|
Ethanol: not more than 0.50% |
Not detected |
||
Ethyl acetate: not more than 0.50% |
Not detected |
||
Dichloromethane: not more than 0.060% |
Not detected |
||
Acetonitrile: not more than 0.041% |
Not detected |
||
Tetrahydrofuran: not more than 0.072% |
Not detected |
||
Benzene: not moare than 0.020% |
Not detected |
||
Pyridine: not more than 0.020% |
Not detected |
||
N,N-Dimethylacetamide: not more than 0.10% |
Not detected |
||
Methylamine: not more than 0.10% |
Not detected |
||
Acetic acid: not more than 0.50% |
Not detected |
||
Fumaric acid content |
23.9%-26.4% |
24.5% |
|
Assay |
NLT 98.0% and NMT 102.0% of C17H16FN3O2S.C4H4O4, calculated on the anhydrous basis |
99.2% |
Vonoprazan Fumarate TAK-438 1260141-27-2

Product: Vonoprazan Fumarate TAK-438
Another name: TAK438; TAK-438
CAS No.: 1260141-27-2
Application: It effectively terminates the secretion of gastric acid, thereby achieving acid suppression
Product Category: Gastrointestinal API, Pepsin digestive enzyme API, Pancreatin digestive enzyme API
Molecular Formula: C21H20FN3O6S
MDL Number: MFCD18633280
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1. Payment term
TT, LC
2. Delivery date
Negotiable
3. Market
Middle East / Africa / Asia / South America / Europe
4. Sample
Available
5. Executive standards
CP, EP, IP
6. Qualification certificate
Registration "A" status of raw material packaging, Notification of Approval of marketing application for chemical API, WC, COPP, CEP, EUGMP, US DMF registration number, India Registration certificate, Brazil registration, Malaysia registration, etc.
7. Packaging size specification
Inner package: single-layer polyethylene bag and aluminum foil bag.
Outer package: fiber drum.
Packaging size: 20 kg/drum; 1kg/drum; 5kg/drum.
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Q: How is Vonoprazan Fumarate API administered?
Q: Are there any known side effects of Vonoprazan Fumarate API?
Q: Can Vonoprazan Fumarate API be used in certain patient populations?
Q: Can Vonoprazan Fumarate API be used during pregnancy or while breastfeeding?
Pregnancy: There is limited information available on the safety of Vonoprazan Fumarate API during pregnancy. Animal studies have shown potential risks to the fetus, but there are no adequate and well-controlled studies in pregnant women. The use of this medication during pregnancy should be carefully evaluated, weighing the potential benefits against the potential risks to the fetus.
Breastfeeding: It is not known whether Vonoprazan Fumarate API is excreted in human breast milk. Studies in animals have shown excretion of the drug and its metabolites in milk. Due to the potential risks to the infant, a decision should be made whether to discontinue breastfeeding or to discontinue the medication, taking into account the importance of the medication to the mother.
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