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N-Desmethyl Ranitidine

  • CAT Number DCTI-C-215
  • CAS Number 66357-25-3
  • Molecular Formula C12H20N4O3S
  • Molecular Weight 300.38

Ranitidine-furoic acid analogue

  • CAT Number DCTI-C-216
  • CAS Number 161271-11-0
  • Molecular Formula C11H15N3O5S
  • Molecular Weight 301.32

General Information

Ranitidine Impurities and Ranitidine  

Daicel Pharma offers high-quality Ranitidine impurity standards, Ranitidine-furoic acid analogue, and N-Desmethyl Ranitidine. The impurities affect Ranitidine’s effectiveness, stability, safety, and quality. Moreover, Daicel Pharma provides customized Ranitidine impurities and ships them worldwide.

Ranitidine [CAS: 66357-35-5] is a furan derivative and treats gastroesophageal reflux disease (GERD) and peptic ulcer disease (PUD). It functions as an anti-ulcer drug.

Ranitidine: Use and Commercial Availability 

Ranitidine is a histamine type 2 receptor antagonist (H2 blocker) that treats acid reflux and heartburn. It is an environmental pollutant, a xenobiotic, and a drug allergen. This drug is available under the brand names Tritec and Zantac.

Ranitidine Structure and Mechanism of Action Ranitidine Structure and Mechanism of Action

The chemical name of Ranitidine is N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N′-methyl-2-nitro-1,1-ethenediamine. Its chemical formula is C13H22N4O3S, and its molecular weight is approximately 314.41 g/mol.

Ranitidine inhibits histamine and prevents acid secretion induced by food.

Ranitidine Impurities and Synthesis

Ranitidine impurities are chemical compounds that occur unintentionally during the manufacturing1 or storage of Ranitidine, a drug used to treat illnesses such as ulcers and gastroesophageal reflux disease (GERD). Impurities occur due to starting materials, reagents, intermediates, or degradation products. Ranitidine impurities require strict control and monitoring to assure Ranitidine’s safety, efficacy, and quality, and analytical procedures help identify, quantify, and characterize these impurities.

Daicel Pharma offers a Certificate of Analysis (CoA) for Ranitidine impurity standards, Ranitidine-furoic acid analogue and N-Desmethyl Ranitidine. Our cGMP-compliant analytical facility provides a comprehensive CoA with detailed characterization data like 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. Additional characterizations like 13C-DEPT are available upon request.


Frequently Asked Questions

Ranitidine impurities require strict control with quality control procedures. Specific limits for impurity levels imposed by regulatory agencies need monitoring.

Impurities in Ranitidine can reduce its effectiveness by affecting the drug's pharmacokinetics, pharmacodynamics, or stability. They need control and monitoring to ensure the medicine retains its therapeutic potency and achieves the targeted therapeutic effects.

Impurities in Ranitidine generics are rigorously examined to ensure their quality, safety, and efficacy.

Ranitidine impurities should be stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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