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PHR1055

Supelco

Famotidine

Pharmaceutical Secondary Standard; Certified Reference Material

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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:
Molecular Weight:
337.45
MDL number:
PubChem Substance ID:
NACRES:
NA.24

biological source

synthetic

Quality Level

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)

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1 of 4

This Item
F00050001269200BP653
Famotidine Pharmaceutical Secondary Standard; Certified Reference Material

PHR1055

Famotidine

Famotidine European Pharmacopoeia (EP) Reference Standard

F0005000

Famotidine

Famotidine United States Pharmacopeia (USP) Reference Standard

1269200

Famotidine

Famotidine British Pharmacopoeia (BP) Reference Standard

BP653

Famotidine

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

technique(s)

-

technique(s)

-

format

neat

format

neat

format

neat

format

neat

Quality Level

300

Quality Level

-

Quality Level

-

Quality Level

-

grade

certified reference material, pharmaceutical secondary standard

grade

pharmaceutical primary standard

grade

pharmaceutical primary standard

grade

pharmaceutical primary standard

storage temp.

2-8°C

storage temp.

2-8°C

storage temp.

2-8°C

storage temp.

2-8°C

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.

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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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)
Blair Kathryn Brettmann et al.
Pharmaceutical research, 30(1), 238-246 (2012-08-28)
To investigate the use of electrospinning for forming solid dispersions containing crystalline active pharmaceutical ingredients (API) and understand the relevant properties of the resulting materials. Free surface electrospinning was used to prepare nanofiber mats of poly(vinyl pyrrolidone) (PVP) and crystalline
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)
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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