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PHR1270

Supelco

Fumaric Acid

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
Fumaric acid
Linear Formula:
HOOCCH=CHCOOH
CAS Number:
Molecular Weight:
116.07
Beilstein:
605763
EC Number:
MDL number:
PubChem Substance ID:
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

vapor pressure

1.7 mmHg ( 165 °C)

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

pharmacopeia traceability

traceable to PhEur F0600000
traceable to USP 1286708

storage temp.

2-8°C

SMILES string

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

InChI

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

InChI key

VZCYOOQTPOCHFL-OWOJBTEDSA-N

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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.

Application

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

Analysis Note

These secondary standards offer multi-traceability to the USP, EP 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 LRAC1693 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Precautionary Statements

Hazard Classifications

Eye Irrit. 2

Storage Class Code

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

Certificate of Analysis

Certificate of Origin

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)
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
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
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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