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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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Quality Level

300

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

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

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.

Analysis Note

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

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

11 - Combustible Solids

flash_point_f

523.4 °F

flash_point_c

273 °C

Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

Substances Subject to be Indicated Names

ishl_indicated

Substances Subject to be Notified Names

ishl_notified

PHR1270-1G: + PHR1270-1G-PW:

jan

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)
Fumaric acid: a new feed additive for pigs.
Nutrition reviews, 43(8), 253-254 (1985-08-01)
Fumaric acid esters, their place in the treatment of psoriasis.
A D Ormerod et al.
The British journal of dermatology, 150(4), 630-632 (2004-04-22)
C Nieboer et al.
Journal of the American Academy of Dermatology, 20(4), 601-608 (1989-04-01)
For the past two decades fumaric acid (FA) therapy has become an increasingly popular treatment in Western Europe for psoriasis. FA therapy originally was developed by Schweckendiek and subsequently standardized by Schäfer. Schäfer's fumaric acid compound therapy (FACT) consists of
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