107880-74-0

Usage

Uses

Used in Pharmaceutical Industry:
Famotidine Acid IMpurity is used as a reference material for the development and validation of analytical methods, quality control, and stability testing of Famotidine in the pharmaceutical industry. Its presence in the final product needs to be monitored and controlled to ensure the safety, efficacy, and quality of the drug.
Used in Research and Development:
Famotidine Acid IMpurity is used as a research compound for studying the effects of impurities on the pharmacological properties, safety, and efficacy of Famotidine. This helps in understanding the potential impact of impurities on the drug's performance and developing strategies to minimize their presence in the final product.
Used in Quality Control:
Famotidine Acid IMpurity is used as a quality control standard to ensure the accuracy and reliability of analytical methods used in the quantification of Famotidine and its related impurities. This helps in maintaining the quality and consistency of the drug across different batches and manufacturers.
Used in Regulatory Compliance:
Famotidine Acid IMpurity is used in the regulatory process to demonstrate compliance with the guidelines and specifications set by regulatory authorities for the manufacture and distribution of Famotidine. This includes the assessment of impurities, their identification, and control to meet the required standards for drug safety and efficacy.

Upstream product

• 76823-94-4 methyl 3-<<<2-<(diaminomethylene)amino>-4-thiazolyl>methyl>thio>propionimidate 
• 76824-35-6 famotidine 
• 76824-35-6 famotidine 

Relevant academic research and scientific papers

Isothermal and nonisothermal decomposition of famotidine in aqueous solution

The kinetics of hydrolysis of famotidine in aqueous solution was studied by isothermal and nonisothermal method over the pH range of 1.71 to 10.0. Nonisothermal kinetics was studied with the purpose of determining its use in the establishment of the expiration date of pharmaceutical preparations, particularly drugs in solutions and for assessment of stability characteristics of pharmaceutical formulations during the development stage. A comparison of isothermal(55, 70 and 85°C) and nonisothermal kinetics was performed. Aqueous solutions of famotidine were buffered at pH 1.71, 2.24, 2.66, 4.0, 8.5, 9.0 and 10.0 were used. In the nonisothermal studies, the temperature rate of the reaction was continuously varied throughout the experiment. The energies of activation were found to be in close agreement for isothermal and nonisothermal studies, indicating that nonisothermal studies may save considerable amount of time in the early stages of drug development and stability testing. Logk-pH profiles were constructed for 55, 70 and 85°C from the first-order rate constants obtained from isothermal studies at pH values ranging from 1.71 to 10.00. The pH-rate profile indicated that famotidine undergoes specific acid catalysis in the acidic region and general base catalysis in the alkaline region. Hydrolysis in the acidic and alkaline media resulted in the formation of four and five degradation products, respectively. A possible degradation pathway for the acidic and alkaline hydrolysis was discussed.

Studies on Histamine H2 Receptor Antagonists. 2. Synthesis and Pharmacological Activities of N-Sulfamoyl and N-Sulfonyl Amidine Derivatives

A series of N-sulfamoyl and N-sulfonyl amidines have been prepared and tested in vitro for H2 antihistamine activity on quinea pig atrium.In addition, several selected compounds were assessed as inhibitors of gastric acid secretion induced by histamine in anesthetized dogs.Structure-activity relationship studies showed that those compounds containing 2-thiazole exhibited potent H2-receptor antagonist activity.Introduction of alkyl or aralkyl groups to the terminal nitrogen of the sulfamoyl moiety reduced biological activities.Sulfamoyl amidines were more potent in both tests than sulfonyl amidines.Of these compounds, 3--4-thiazolyl>methyl>thio>-N2-sulfamoylpropionamide (2e, famotidine) showed extremely high potency in both assays and was selected for clinical trials as an antiulcer agent.Acid-catalyzed hydrolysis of famotidine gave the sulfamoyl amide 6 at room temperature and the carboxylic acid 7 at elevated temperatures. 15 N NMR spectrum showed that famotidine in solution existed in only one of several possible tautomers derived from the amidine and the guanidine moieties.Nitrosation of famotidine was performed under mild condition and proved to occur on the 5-position of the thiazole ring.