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Merck
CN

PHR1055

法莫替丁

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

N′-（氨基磺酰基）-3-([2-（二氨基亚甲基氨基）-4-噻唑基]甲硫基)丙脒

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关于此项目

经验公式（希尔记法）:
C8H15N7O2S3
化学文摘社编号:
76824-35-6
分子量:
337.45
NACRES:
NA.24
PubChem Substance ID:
329823085
UNSPSC Code:
41116107
MDL number:
MFCD00079297

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产品名称

法莫替丁, Pharmaceutical Secondary Standard; Certified Reference Material

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

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

Quality Level

300

Gene Information

human ... HRH2(3274)

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相关类别

Biochem/physiol Actions

H2组胺受体拮抗剂；抗溃疡剂。

Analysis Note

These secondary standards offer multi-traceability to the USP and EP (PhEur) primary standards, where they are available.

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.

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.

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.

存储类别

11 - Combustible Solids

wgk

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable

分析证书(COA)

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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)
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
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
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