Pantoprazole Sodium Sesquihydrate

Pantoprazole Sodium Sesquihydrate Specification

Heavy Metal (%)
20 ppm

Moisture (%)
5.0%

Molecular Weight
432.4 g/mol

Molecular Formula
C16H15F2N3NaO4S1.5H2O

Ph Level
9.0 - 10.5 (1% aqueous solution)

Loss on Drying
5.0%

Residue on Ignition
0.1%

Boiling point
(Decomposes before boiling)

Storage
Store in a cool dry place. Protect from light and moisture.

EINECS No
605-195-7

Assay
98.5% - 101.0%

Particle Size
Micronized d90 10 m

Melting Point
210 - 220C

HS Code
29339990

Other Names
Pantoprazole sodium hydrous form

CAS No
164579-32-2

Type
Active Pharmaceutical Ingredient

Grade
Pharma Grade

Usage
Used in the treatment of gastrointestinal conditions such as acid reflux and ulcers

Purity
99% Min

Appearance
White or off-white crystalline powder

Application
Pharmaceutical formulations particularly anti-ulcer medications

Raw Material
Pantoprazole base

Smell
Odorless

Color
White to off-white

Form
Crystalline Powder

About Pantoprazole Sodium Sesquihydrate

SL.

NO.

TESTS

RESULTS

SPECIFICATIONS

Description

Solubility

Identification

a) By IR

b) By HPLC

Water by K.F

Heavy metals

Related Substances (by HPLC% area normalization)

a) Single Impurity

b) Total Impurity

Assay (% w/w by HPLC, as C16 F2H14 N3 NaO4S on Anhydrous basis)

Complies

5.21% w/w

Less than 20 p pm

0.16%

0.57%

98.43%w/w

White to almost white colored crystalline powder.

Soluble in Water and practically insoluble in Dichloride methane.

Should match with that of standard.

The sample RT should correspond with that if standard

Between 4.5% and 8.0% w/w

Not more than 20 p pm

Not more than 0.5%

Not more than 1.0%

Between 98.0% to 102.0% w/w

FAQs of Pantoprazole Sodium Sesquihydrate:

Q: What is the molecular weight of Pantoprazole Sodium Sesquihydrate?

A: The molecular weight of Pantoprazole Sodium Sesquihydrate is 432.4 g/mol.

Q: What is the application of Pantoprazole Sodium Sesquihydrate?

A: Pantoprazole Sodium Sesquihydrate is used in pharmaceutical formulations particularly anti-ulcer medications.

Q: What is the purity of Pantoprazole Sodium Sesquihydrate?

A: The purity of Pantoprazole Sodium Sesquihydrate is 99% Min.

Q: How should Pantoprazole Sodium Sesquihydrate be stored?

A: Pantoprazole Sodium Sesquihydrate should be stored in a cool dry place, protected from light and moisture.

Q: What is the color of Pantoprazole Sodium Sesquihydrate?

A: Pantoprazole Sodium Sesquihydrate is white to off-white in color.

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