PHR1055

Famotidine

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): {3-[((2-((Aminoiminomethyl)amino)-4-thiazolyl)methyl)thio]-N′-(aminosulfonyl)propaneimidamide}, N′-(Aminosulfonyl)-3-([2-(diaminomethyleneamino)-4-thiazolyl]methylthio)propanamidine
• Empirical Formula (Hill Notation): C₈H₁₅N₇O₂S₃
• CAS Number: 76824-35-6
• Molecular Weight: 337.45
• MDL number: MFCD00079297
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823085
• NACRES: NA.24

Properties

• biological source: synthetic
• Quality Level: 300
• grade: certified reference material; pharmaceutical secondary standard
• Agency: BP; EP; USP; traceable to BP 653; traceable to Ph. Eur. F0050000; traceable to USP 1269200
• vapor pressure: <0.0000001 kPa ( 25 °C)
• API family: famotidine
• CofA: current certificate can be downloaded
• packaging: pkg of 1 g
• storage condition: protect from light (20 mm aluminium crimp seal for unused portion)
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• color: white to pale yellow-white
• mp: 325.4-327.2 °F (163—164°C)
• solubility: DMF: freely soluble; acetone: practically insoluble; chloroform: practically insoluble; ethanol: practically insoluble; ether: practically insoluble; ethyl acetate: practically insoluble; glacial acetic acid: freely soluble; methanol: slightly soluble; water: very slightly soluble
• application(s): pharmaceutical (small molecule)
• format: neat
• shipped in: ambient
• storage temp.: 2-8°C
• SMILES string: N\C(N)=N\c1nc(CSCCC(=N)NS(N)(=O)=O)cs1
• InChI: 1S/C8H15N7O2S3/c9-6(15-20(12,16)17)1-2-18-3-5-4-19-8(13-5)14-7(10)11/h4H,1-3H2,(H2,9,15)(H2,12,16,17)(H4,10,11,13,14)
• InChI key: XUFQPHANEAPEMJ-UHFFFAOYSA-N
• Gene Information: human ... HRH2(3274)

Description

General description

Famotidine is a histamine H2-receptor antagonist, which promotes the healing of erosive esophagitis, gastric and duodenal ulcers since it inhibits the gastric acid secretion in humans.
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

Famotidine may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using different chromatography 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

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 LRAA7133 in the 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
• WGK: WGK 2
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable