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PHR1773

Supelco

Ranitidine Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

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

Quality Level

grade

certified reference material
pharmaceutical secondary standard

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

pharmacopeia traceability

traceable to USP 1598507

storage temp.

2-8°C

SMILES string

OC(=O)\C=C\C(O)=O.CN(C)Cc1ccc(CSCCN)o1

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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

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.
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.

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.

Storage Class Code

13 - Non Combustible Solids

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

Simultaneous determination of ranitidine and metronidazole in pharmaceutical formulations at poly (chromotrope 2B) modified activated glassy carbon electrodes
Li X and Xu G
Journal of food and drug analysis, 22(3), 345-349 (2014)
Kinetic spectrophotometric determination of nizatidine and ranitidine in pharmaceutical preparations
Hassan ME and Belal F
Journal of Pharmaceutical and Biomedical Analysis, 27(1-2), 31-38 (2002)

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