Buy Pantoprazole Sodium Sesquihydrate Powder Pharmaceutical Raw Materials Online CAS 164579-32-2
Pantoprazole Sodium Sesquihydrate Specification
Product Name: Pantoprazole Sodium Hydrate CAS: 164579-32-2 Content: 98% Appearance: white powder Packing: 25 kg / cardboard drum detachable Ingredients: Pantoprazole Sodium Hydrate 98 Physical and chemical properties: This product is white or off-white crystalline powder. This product is soluble in water or methanol and hardly soluble in chloroform or ether. Category: Pharmaceutical raw materials Use: For the treatment of peptic ulcer (gastric ulcer and duodenal ulcer), Zhuo-Ehrlich syndrome and reflux esophagitis.
Pantoprazole Sodium Sesquihydrate Certificate of Analysis
Product name
pantoprazole sodium sesquihydrate
CAS No.
164579-32-2
Outer Packing
25KG/DRUM
Production date
12/05/2018
Shelf life
11/05/2022
Standard adopted
IP
Items of analysis
Specification
Results
description
white to off white color powder
off white color powder
solubility
freely soluble in water and methanol and dehydrated ethanol(95%),practically insoluble in hexane & in dichloromethane.
freely soluble in water and methanol and dehydrated ethanol(95%),practically insoluble in hexane & in dichloromethane
identification
A.by HPLC
in the assay,the principal peak in the chromatogram obtained with the test solution corresponds to the principal peak in the chromatogram obtained with the reference solution
complies
B.test for sodium
it gives the reaction of sodium
complies
optical rotation
between-0.40°to +0.40°
+0.10°
water content by KF
between 5.0% to 8.0% w/w
5.5% w/w
heavy metals
not more than 20ppm
less than 20ppm
related substances(by HPLC)
impurity-C ≦-0.5% individual impurity:-≦0.5% Total impurities ≦-1.0%
Not detected 0.15% 0.42%
assay by HPLC(on anhydrous basis)
98%-102%
99.6%
Conclusion
Qualified
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