PHR1773

Ranitidine Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 2-{{{5-[(Dimethylamino)methyl]furan-2-yl}methyl}sulfanyl}ethanamine hemifumarate salt, 2-{{{5-[(DIMETHYLAMINO)METHYL] FURAN-2-YL}METHYL}SULFANYL} ETHANEAMINEHEMIFUMARATE SALT, Ranitidine Impurity B, 2-{{{5-[(Dimethylamino)methyl]-2-furanyl}methyl}thio}ethylamine hemifumarate salt, 5-{[(2-Aminoethyl)thio]methyl}-N,N-dimethyl- 2-furanmethanamine hemifumarate salt, Ranitidine diamine hemifumarate salt
• Empirical Formula (Hill Notation): C₁₀H₁₈N₂OS · 0.5 C₄H₄O₄
• CAS Number: 91224-69-0
• Molecular Weight: 272.36
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to USP 1598507
• API family: ranitidine
• CofA: current certificate can be downloaded
• packaging: pkg of 100 mg
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• SMILES string: OC(=O)\C=C\C(O)=O.CN(C)Cc1ccc(CSCCN)o1

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. Ranitidine Related Compound A is an impurity of ranitidine, an inhibitor of gastric acid secretion. Ranitidine is widely used for treating gastric and duodenal ulcers.

Application

Ranitidine may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using kinetic spectrophotometric technique and electrochemical method.

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 LRAC0714 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Storage Class Code: 11 - Combustible Solids
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable