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PHR1604

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

Agency

traceable to Ph. Eur. Y0000835
traceable to USP 1494895

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

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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Related Categories

Pharmacopeia & Metrological Institute Standards

Certified Reference Materials

Analytical Reference Materials for the Pharma Industry

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

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)