PHR1987

Omeprazole Impurity B

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 2-[(RS)-[(3,5-Dimethylpyridin-2-yl)methyl]sulfinyl]-5-methoxy-1H-benzimidazole, 2-[(RS)-[(3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-5-methoxy-1h-benzimidazole, 2-[[(3,5-Dimethyl-2-pyridinyl)methyl]sulfinyl]--6-methoxy-1H-benzimidazol, 4-Desmethoxy Omeprazole
• Empirical Formula (Hill Notation): C₁₆H₁₇N₃O₂S
• CAS Number: 110374-16-8
• Molecular Weight: 315.39
• Beilstein: 6573983
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• API family: omeprazole
• CofA: current certificate can be downloaded
• packaging: pkg of 30 mg
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• InChI: 1S/C16H17N3O2S/c1-10-6-11(2)15(17-8-10)9-22(20)16-18-13-5-4-12(21-3)7-14(13)19-16/h4-8H,9H2,1-3H3,(H,18,19)
• InChI key: ZMXZYNHJPJEPAE-UHFFFAOYSA-N

Description

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. Omeprazole Impurity B is found to be as an impurity of omeprazole. Omeprazole is a benzimidazole derivative, which is widely used as an antiulcer drug and against other acid-related diseases.

Application

Olmesartan medoxomil may be used as a pharmaceutical secondary standard for the determination of the analyte in pharmaceutical formulations using different analytical techniques.

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 LRAB4099 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS07,GHS09
• Signal Word: Warning
• Hazard Statements: H302,H315,H411
• Precautionary Statements: P264 - P273 - P280 - P301 + P312 - P302 + P352 - P332 + P313
• Hazard Classifications: Acute Tox. 4 Oral - Aquatic Chronic 2 - Skin Irrit. 2
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable