Pantoprazole Sodium Sesquihydrate

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Product Details:

EINECS No 605-195-7
Assay 98.5% - 101.0%
Particle Size Micronized d90 10 m
Molecular Weight 432.4 g/mol
Molecular Formula C16H15F2N3NaO4S1.5H2O
HS Code 29339990
Boiling point (Decomposes before boiling)
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Pantoprazole Sodium Sesquihydrate Product Specifications

Color White to off-white
HS Code 29339990
Molecular Formula C16H15F2N3NaO4S1.5H2O
Type Active Pharmaceutical Ingredient
Grade Pharma Grade
Assay 98.5% - 101.0%
Particle Size Micronized d90 10 m
Molecular Weight 432.4 g/mol
EINECS No 605-195-7
Form Crystalline Powder
Purity 99% Min
Usage Used in the treatment of gastrointestinal conditions such as acid reflux and ulcers
Residue on Ignition 0.1%
Loss on Drying 5.0%
CAS No 164579-32-2
Other Names Pantoprazole sodium hydrous form
Moisture (%) 5.0%
Melting Point 210 - 220C
Ph Level 9.0 - 10.5 (1% aqueous solution)
Storage Store in a cool dry place. Protect from light and moisture.
Application Pharmaceutical formulations particularly anti-ulcer medications
Heavy Metal (%) 20 ppm
Raw Material Pantoprazole base
Smell Odorless
Appearance White or off-white crystalline powder
Boiling point (Decomposes before boiling)

Product Description

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

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