97% up by HPLC, EP/GMP/DMF Rabeprazole Sodium 117976-90-6 | Pharmaceutical Materials

Product Catagories

Medical Raw Materials

首页 > Pharmaceutical Materials > 97% up by HPLC, EP/GMP/DMF Rabeprazole Sodium 117976-90-6

97% up by HPLC, EP/GMP/DMF Rabeprazole Sodium 117976-90-6

单价	面议对比
询价	暂无
发货	全国
过期	长期有效
更新	2025-08-13 23:38

详细信息

Grade: Pharmaceutical Grade

Factory Location: Xiamen, Fujian

Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East

Monthly Production Capacity: 1000kg

Packaging Information: 25kg/drum 1kg/bottle

Delivery Lead Time: 7 days after payment

Sample Provided: yes

Payment Terms: L/L

Product Information

Product name	Rabeprazole Sodium
CAS No.	117976-90-6
Molecular Formula	C18H20N3NaO3S
Molecular Weight	381.4245
Quality Standard	97% up by HPLC, EP8/GMP/DMF
Appearance	White powder

COA of Rabeprazole Sodium

ITEMS	STANDARDS	RESULTS
Appearance	White or slightly yellowish-white hygoscopic powder	Slightly yellowish-white hygoscopic powder
Solubility	Very soluble to freely soluble in water, and freely soluble in anhydrous ethanol, practically insoluble in heptane.	Complies
Identification	Infrared absorption spectrum is identical to that of rebeprazole sodium reference standard.	Complies
Identification	It gives reaction (a) of sodium	Complies
pH	9.5-11.5	10.5
Related substances (HPLC)	Impurity A: NMT 0.8%	0.05%
	Unspecified impurities: NMT 0.10%	0.09%
	Total impurities: NMT 1.0%	0.28%
Related substances (GC)	Methylene chloride: NMT 600ppm	<LOD(LOD=62ppm)
	Ethanol: NMT5000ppm	<LOD(LOD=62ppm)
	Isopropyl ether: NMT5000ppm	10ppm
	Acetone: NMT5000ppm	26ppm
Assay	97.0%-102.0%, calculated on the dried basis	100.6%
Microbial limit	Total aerobic microbial count ≤ 1000cfu/g	< 10cfu/g
	Total combined yeasts and molds count ≤ 100cfu/g	< 10cfu/g
	Escherichia coli: absence in 1g	Complies
Conclusion	Complies with the requirements of EP8.7

Usage

Function of Rabeprazole Sodium

Rabeprazole is a treatment drug for digestive tract diseases. Its main function is to inhibit the secretion of gastric acid. It is a proton pump inhibitor. This drug has an inhibitory effect on basic gastric acid and the secretion of gastric acid caused by stimulation. It can inhibit the secretion of gastric acid and can also resist Helicobacter pylori. In addition, this drug has no antagonistic effect on choline receptors and histamine receptors. Clinically, rabeprazole is mainly suitable for gastrointestinal diseases such as peptic ulcer and reflux esophagitis.

This drug is relatively safe when used, and there are generally no obvious serious adverse reactions. Patients occasionally see milder side effects such as diarrhea, nausea, fatigue, and dry mouth, which usually disappear after stopping the drug.

Product Information

Product name

Rabeprazole Sodium

CAS No.

117976-90-6

Molecular Formula

C18H20N3NaO3S

Molecular Weight

381.4245

Quality Standard

97% up by HPLC, EP8/GMP/DMF

Appearance

White powder

COA of Rabeprazole Sodium

ITEMS

STANDARDS

RESULTS

Appearance

White or slightly yellowish-white hygoscopic powder

Slightly yellowish-white hygoscopic powder

Solubility

Very soluble to freely soluble in water, and freely soluble in anhydrous ethanol, practically insoluble in heptane.

Complies

Identification

Infrared absorption spectrum is identical to that of rebeprazole sodium reference standard.

Complies

It gives reaction (a) of sodium

Complies

pH

9.5-11.5

10.5

Related substances

(HPLC)

Impurity A: NMT 0.8%

0.05%

Unspecified impurities: NMT 0.10%

0.09%

Total impurities: NMT 1.0%

0.28%

Related substances

(GC)

Methylene chloride: NMT 600ppm

<LOD(LOD=62ppm)

Ethanol: NMT5000ppm

<LOD(LOD=62ppm)

Isopropyl ether: NMT5000ppm

10ppm

Acetone: NMT5000ppm

26ppm

Assay

97.0%-102.0%, calculated on the dried basis

100.6%

Microbial limit

Total aerobic microbial count ≤ 1000cfu/g

< 10cfu/g

Total combined yeasts and molds count ≤ 100cfu/g

< 10cfu/g

Escherichia coli: absence in 1g

Complies

Conclusion

Complies with the requirements of EP8.7

Usage

Function of Rabeprazole Sodium

This drug is relatively safe when used, and there are generally no obvious serious adverse reactions. Patients occasionally see milder side effects such as diarrhea, nausea, fatigue, and dry mouth, which usually disappear after stopping the drug.