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PHR1604

Supelco

Pantoprazole Sodium

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Pantoprazole sodium sesquihydrate
Empirical Formula (Hill Notation):
C16H14F2N3NaO4S · 1.5H2O
CAS Number:
164579-32-2
Molecular Weight:
432.37
NACRES:
NA.24

Quality Level

300

grade

certified reference material
pharmaceutical secondary standard

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to PhEur Y0000835
traceable to USP 1494895

storage temp.

2-8°C

InChI

1S/C16H16F2N3O4S.Na.H2O/c1-23-13-5-6-19-12(14(13)24-2)8-26(22)16-20-10-4-3-9(25-15(17)18)7-11(10)21-16;;/h3-7,15-16,21H,8H2,1-2H3;;1H2/q-1;+1;

InChI key

QHNXIKDJFYGZTL-UHFFFAOYSA-N

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General description

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards. Pantoprazole Sodium is an acid-suppresive agent widely used for the treatment of gastric ulcers via inhibition of gastric acid secretion by selectively binding to the gastric enzyme, H+, K+,-ATP-ase.

Application

Pantoprazole Sodium may be used as a pharmaceutical secondary standard for the determination of the analyte in pharmaceutical formulations using spectrophotometric technique.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB7814 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation mark
GHS07

Signal Word

Warning

Hazard Statements

H302

Precautionary Statements

P301 + P312 + P330

Hazard Classifications

Acute Tox. 4 Oral

Storage Class Code

13 - Non Combustible Solids

WGK

nwg

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

Analogue-based Drug Discovery, 2(1) (2006)
Validated spectrophotometric determination of pantoprazole sodium in pharmaceuticals using ferric chloride and two chelating agents
Devi ZO and Basavaiah K
International Journal of ChemTech Research, 2(1) (2010)

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