Description

Technical Parameters

This medication is indicated for the treatment of gastric ulcers, duodenal ulcers, reflux esophagitis, erosive esophagitis, gastroesophageal reflux disease (GERD), Helicobacter pylori infection, and peptic ulcers.

Vonoprazan demonstrates acid stability and is rapidly absorbed when taken on an empty stomach, reaching peak plasma concentration (Cmax) within 1.5 to 2 hours after ingestion. It exhibits slow dissociation with a half-life of approximately 7.7 hours. Its high pKa value (>9) facilitates its accumulation in the luminal space of parietal cell canaliculi, competitively inhibiting the opening and closing of the proton pump. We could also offer N-1 CAS NO: 881674-56-2; CAS NO: 16133-25-8.

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%
	Organic Impurities	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 CAS 881681-01-2

Product: Vonoprazan Fumarate CAS 881681-01-2
Chemical Name: 1-(5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine fumarate
Another name: TAK438; TAK-438; MFCD18633280; 1260141-27-2 TAK-438 AKSci J97352; Fumarat Vonoprazana; Vonoprazan Fumarate-D3; N-methyl-1-(3-pyridyl sulfonyl)-1H-pyrrole-3-methanamine; 1-(5-(2-Fluorophenyl); AB457904 CAS 881681-01-2;
CAS No.: 881681-01-2
Product Category: Gastrointestinal API, Pepsin digestive enzyme API, Pancreatin digestive enzyme API
Molecular Weight: 461.46300
Molecular Formula: C₂₁H₂₀FN₃O₆S
MDL Number: MFCD18633280

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.

Vonoprazan fumarate (TAK-438) offers several benefits as a proton pump inhibitor (PPI) for the treatment of acid-related gastrointestinal disorders. Some of the benefits include:

1. Potent and Rapid Acid Suppression: Vonoprazan provides strong and rapid inhibition of gastric acid secretion. It effectively blocks the H+/K+-ATPase enzyme, resulting in a significant reduction in stomach acid production. This potent acid suppression can lead to faster symptom relief and improved healing of gastric ulcers and esophageal damage.

2. Longer Duration of Action: Vonoprazan has a longer duration of action compared to traditional PPIs. It maintains effective acid suppression for an extended period, allowing for once-daily dosing. This convenience can improve patient adherence to the treatment regimen.

3. Improved Control of Nocturnal Acid Breakthrough: Nocturnal acid breakthrough refers to the reoccurrence of gastric acid secretion during the night, which can disrupt sleep and worsen symptoms. Vonoprazan has demonstrated superior control of nocturnal acid breakthrough compared to other PPIs, ensuring better acid suppression during the night.

4. Enhanced Healing of Gastrointestinal Ulcers: Vonoprazan promotes the healing of gastric and duodenal ulcers by reducing acid secretion and creating a favorable environment for tissue repair. Studies have shown that vonoprazan achieves higher healing rates compared to traditional PPIs, leading to faster resolution of ulcers.

5. Potential for Refractory Acid-Related Disorders: Vonoprazan may be beneficial for patients with refractory acid-related disorders, including those who do not respond adequately to standard PPI therapy. Its potent acid-suppressing properties make it a valuable alternative for individuals who require more aggressive acid control.

6. Reduced Risk of Drug Interactions: Vonoprazan has a lower potential for drug interactions compared to some other PPIs. It is less likely to interfere with the metabolism of certain medications, reducing the risk of adverse effects or compromised therapeutic efficacy.

Our Advantage

We have branch offices in Dubai and India

we have own reliable & Long-term cooperative & experienced factory

Variety products for selection from China and India

We can customize according to your requirements

We can do OEM & ODM

We can offer N-1 to API

Vonoprazan Fumarate CAS 881681-01-2 FAQ

Q: What is Vonoprazan Fumarate API?

A: Vonoprazan Fumarate API, also known by its brand name TAK-438, is a potent potassium-competitive acid blocker (P-CAB) and reversible proton pump inhibitor (PPI). It is used for the treatment of various gastrointestinal conditions such as gastric ulcers, duodenal ulcers, reflux esophagitis, and Helicobacter pylori infection.

Q: How does Vonoprazan Fumarate API work?

A: Vonoprazan Fumarate API acts by inhibiting the H+, K+-ATPase enzyme (proton pump) in the gastric parietal cells. This inhibition leads to a reduction in the production of gastric acid, thereby providing effective acid suppression and promoting the healing of gastrointestinal ulcers.

Q: What are the potential advantages of Vonoprazan Fumarate API over other acid-suppressing medications?

A: Vonoprazan Fumarate API has been reported to have several advantages over traditional proton pump inhibitors (PPIs). It exhibits a rapid onset of action, with faster and more potent acid suppression. It also maintains acid suppression over a longer duration, leading to sustained therapeutic effects. Additionally, Vonoprazan Fumarate API has shown efficacy in patients who have not responded well to conventional PPI therapy.

Q: What are the potential uses or applications of Vonoprazan fumarate (TAK-438)?

A: TAK-438, also known as vonoprazan, has several potential uses or applications:
1. Treatment of gastroesophageal reflux disease (GERD): TAK-438 can be used to alleviate the symptoms and manage the complications associated with GERD, such as heartburn, acid regurgitation, and esophageal damage caused by excessive gastric acid.

2. Healing of gastric and duodenal ulcers: TAK-438 is effective in promoting the healing of gastric and duodenal ulcers by reducing gastric acid secretion and creating a favorable environment for tissue repair.

3. Management of reflux esophagitis: TAK-438 can help alleviate the inflammation and damage to the esophagus caused by the backflow of stomach acid in reflux esophagitis.

4. Treatment of Helicobacter pylori infection: TAK-438 can be used as part of a combination therapy to eradicate Helicobacter pylori, a bacterium associated with gastritis, peptic ulcers, and certain types of stomach cancer.

5. Prevention of non-steroidal anti-inflammatory drug (NSAID)-induced gastric ulcers: TAK-438 has shown efficacy in reducing the risk of gastric ulcers associated with the use of NSAIDs, which are commonly used for pain relief but can cause gastric damage.

It is important to note that the specific uses and applications of TAK-438 may vary depending on the regulatory approvals and guidelines in different countries or regions. It is always recommended to consult with a healthcare professional for accurate and up-to-date information regarding the appropriate use of TAK-438.

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