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Merck

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

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About This Item

Empirical Formula (Hill Notation):
C8H15N7O2S3
CAS Number:
76824-35-6
Molecular Weight:
337.45
NACRES:
NA.24
PubChem Substance ID:
329823085
UNSPSC Code:
41116107
MDL number:
MFCD00079297

Key Documents

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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)

SMILES string

N\C(N)=N\c1nc(CSCCC(=N)NS(N)(=O)=O)cs1

InChI key

XUFQPHANEAPEMJ-UHFFFAOYSA-N

biological source

synthetic

grade

certified reference material, pharmaceutical secondary standard

agency

BP, EP, USP, 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

Quality Level

300

Gene Information

human ... HRH2(3274)

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

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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 and EP (PhEur) 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.
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.

Storage Class

11 - Combustible Solids

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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The
Profiles of Drug Substances, Excipients, and Related Methodology (2011)
GC Determination of famotidine, ranitidine, cimetidine, and metformin in pharmaceutical preparations and serum using methylglyoxal as derivatizing reagent
Majidano AS, et al.
Chromatographia, 75(21-22), 1311-1317 (2012)
High-performance thin-layer chromatography for the determination of ranitidine hydrochloride and famotidine in pharmaceuticals.
Novakovic J.
Journal of Chromatography A, 846(1-2), 193-198 (1999)
Kenichi Yamamoto et al.
Journal of orthopaedic research : official publication of the Orthopaedic Research Society, 30(12), 1958-1962 (2012-05-18)
Heterotopic ossification or calcification follows any type of musculoskeletal trauma and is known to occur after arthroplasties of hip, knee, shoulder, or elbow; fractures; joint dislocations; or tendon ruptures. Histamine receptor H2 (Hrh2) has been shown to be effective for
Abolfazl Razzaghdoust et al.
The Prostate, 74(1), 41-47 (2013-09-11)
Ionizing radiation causes a series of hematological alterations especially profound lymphocytopenia during and after the radiotherapy course. To investigate whether famotidine can reduce hematologic toxicity in patients treated with radiotherapy for prostate cancer. A total of 36 patients undergoing radiotherapy
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