PHR1026

Ranitidine hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): N, N Dimethyl-5-[2-(1-methylamine-2-nitrovinyl)-ethylthiomethyl]furfurylamine hydrochloride
• Empirical Formula (Hill Notation): C₁₃H₂₂N₄O₃S · HCl
• CAS Number: 66357-59-3
• Molecular Weight: 350.86
• EC Number: 266-333-0
• MDL number: MFCD00069339
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823056
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 471; traceable to Ph. Eur. R0150000; traceable to USP 1598405
• API family: ranitidine
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: Cl[H].CN\C(NCCSCc1ccc(CN(C)C)o1)=C\[N+]([O-])=O
• InChI: 1S/C13H22N4O3S.ClH/c1-14-13(9-17(18)19)15-6-7-21-10-12-5-4-11(20-12)8-16(2)3;/h4-5,9,14-15H,6-8,10H2,1-3H3;1H/b13-9-;
• InChI key: GGWBHVILAJZWKJ-CHHCPSLASA-N

Description

General description

Ranitidine hydrochloride is a H₂-receptor antagonist, widely used for the management of hypersecretory conditions and for the treatment of duodenal ulcer.
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

Ranitidine hydrochloride may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using titrimetry and visible spectrophotometry 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.

Biochem/physiol Actions

H2 histamine receptor antagonist; anti-ulcer agent.

H₂ histamine receptor antagonist; anti-ulcer agent.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) 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 LRAA5630 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS08,GHS07
• Signal Word: Danger
• Hazard Statements: H315,H317,H319,H334,H335
• Precautionary Statements: P261 - P264 - P271 - P280 - P302 + P352 - P305 + P351 + P338
• Hazard Classifications: Eye Irrit. 2 - Resp. Sens. 1 - Skin Irrit. 2 - Skin Sens. 1 - STOT SE 3
• Target Organs: Respiratory system
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 2
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable