PHR1585

Esomeprazole Magnesium

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): (S)-Omeprazole magnesium trihydrate, 5-Methoxy-2-{(S)-[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl] sulfinyl} benzimidazole magnesium trihydrate
• Empirical Formula (Hill Notation): C₃₄H₃₆MgN₆O₆S₂ · 3H₂O
• CAS Number: 217087-09-7
• Molecular Weight: 767.17
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to Ph. Eur. Y0001028; traceable to USP 1249789
• API family: omeprazole
• CofA: current certificate can be downloaded
• packaging: ampule of 1 g
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• InChI: 1S/2C17H18N3O3S.Mg.3H2O/c2*1-10-8-18-15(11(2)16(10)23-4)9-24(21)17-19-13-6-5-12(22-3)7-14(13)20-17;;;;/h2*5-8H,9H2,1-4H3;;3*1H2/q2*-1;+2;;;
• InChI key: VEVZQDGATGBLIC-UHFFFAOYSA-N

Description

General description

Esomeprazole Magnesium is theS-isomer of omeprazole and is widely used for the treatment of acid related diseases. It is the first single optical isomer proton pump inhibitor and is found to be better over omeprazole in terms of pharmacokinetic characteristics and acid suppression.
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.

Application

Esomeprazole Magnesium may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using UV-Vis spectroscopy technique and 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 LRAC1677 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable