Vonoprazan fumarate TAK438

DETAILS

Description:

HM781-36B is a drug in development by Hanmi Pharmaceutical (in South Korea), Luye Pharma (China), and Spectrum Pharmaceuticals (rest of world) for various cancers. It is built on an anilino-quinoline scaffold and inhibits the epidermal growth factor receptors EGRF, HER2/neu, and Her 4 and binds covalently to its targets

Product Name	Vonoprazan fumarate TAK438
CAS	1260141-27-2
Appearance	A White to off-white or tan solid powder
Molecular formula	C21H20FN3O6S
Molecular Weight	461.46
Assay	99%
Shelf Life	24 months when properly stored
Storage	Keep in a cool, dry, dark location

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.
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 cell

Certificate of Analysis

Batch Number		Z20190412001
Production Date		2019.04.12
Batch Quantity		80 KGS
Item	Test Standard		Testing Result
Appearance	Powder		Complies
Color	white Powder		Complies
Particle Size	100% pass 80 mesh		Complies
Oder	Characteristic		Complies
Taste	Characteristic		Complies
Loss on Drying	≤5.0%		2.20%
Residue on Ignition	≤0.1%		0.05%
Residual acetone	≤0.1%		Complies
Residual Ethanol	≤0.5%		Complies
Heave Mentals	≤10ppm		Complies
Na	≤0.1%		<0.1%
Pb	≤3 ppm		Complies
Total Plate	<1000CFU/g		Complies
Yeast & Mold	<100 CFU /g		Complies
E. Coli	Negative		Complies
Salmonella	Negative		Complies
Conclusion: Conform with USP Standard