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Merck

PHR1270

Fumaric Acid

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Fumaric acid

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About This Item

Linear Formula:
HOOCCH=CHCOOH
CAS Number:
110-17-8
Molecular Weight:
116.07
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823266
EC Number:
203-743-0
Beilstein/REAXYS Number:
605763
MDL number:
MFCD00002700

Key Documents

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Product Name

Fumaric Acid, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

VZCYOOQTPOCHFL-OWOJBTEDSA-N

InChI

1S/C4H4O4/c5-3(6)1-2-4(7)8/h1-2H,(H,5,6)(H,7,8)/b2-1+

SMILES string

OC(=O)\C=C\C(O)=O

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. F0600000
traceable to USP 1286708

vapor pressure

1.7 mmHg ( 165 °C)

API family

fumaric acid

CofA

current certificate can be downloaded

autoignition temp.

1364 °F

expl. lim.

40 %

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

298-300 °C (subl.) (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

Quality Level

300

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Analysis Note

These secondary standards offer multi-traceability to the US and EP primary standards, where they are available.

Application

Fumaric Acid may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by spectrophotometry.
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

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

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.
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 LRAC1693 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Exclamation mark
GHS07

signalword

Warning

hcodes

H319

Hazard Classifications

Eye Irrit. 2

Storage Class

13 - Non Combustible Solids

wgk

WGK 1

flash_point_f

521.6 - 525.2 °F - open cup

flash_point_c

272 - 274 °C - open cup

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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Spectrophotometric estimation of ketotifen fumarate in pharmaceutical formulations
Sastry CSP and Naidu PY
Microchimica Acta, 127(3-4), 219-223 (1997)
Spectrophotometric determination of ascorbic acid in pharmaceuticals by background correction and flow injection
Verma KK, et al.
Analyst, 116(6), 641-645 (1991)
B Sebók et al.
Orvosi hetilap, 141(3), 129-132 (2000-02-29)
The treatment of psoriasis vulgaris with fumaric acid esters has been controversial for more than 30 years. Recently the fumaric acid derivatives are marketed antipsoriatics in many European countries. In this paper the clinical efficacy, the side effects as well
R Gold et al.
Clinical immunology (Orlando, Fla.), 142(1), 44-48 (2011-03-19)
Fumaric acid was originally therapeutically used in psoriasis. Several lines of evidence have demonstrated immunomodulatory but also neuroprotective effects for FAE. Clinical studies in psoriasis showed a reduction of peripheral CD4+ and CD8+ T-lymphocytes due to the ability of FAE
Management of psoriasis vulgaris and multiple sclerosis with fumaric acid.
Spyridon Gkalpakiotis et al.
Journal of the American Academy of Dermatology, 70(3), e60-e61 (2014-02-18)
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