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PHR1270

Supelco

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
Beilstein:
605763
EC Number:
203-743-0
MDL number:
MFCD00002700
UNSPSC Code:
41116107
PubChem Substance ID:
329823266
NACRES:
NA.24
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grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

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.)

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1 of 4

This Item
F060000012867088.17073
Fumaric Acid Pharmaceutical Secondary Standard; Certified Reference Material

PHR1270

Fumaric Acid

Fumaric acid European Pharmacopoeia (EP) Reference Standard

F0600000

Fumaric acid

Fumaric acid United States Pharmacopeia (USP) Reference Standard

1286708

Fumaric acid

Acide fumarique EMPROVE® ESSENTIAL, NF, JPE

8.17073

Acide fumarique

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

liquid formulation
pharmaceutical
solid formulation

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

technique(s)

-

technique(s)

API processing | cocrystal formation: suitable, API processing | salt formation: suitable

format

neat

format

neat

format

neat

format

-

Quality Level

300

Quality Level

-

Quality Level

-

Quality Level

500

grade

certified reference material, pharmaceutical secondary standard

grade

pharmaceutical primary standard

grade

pharmaceutical primary standard

grade

-

storage temp.

2-8°C

storage temp.

-

storage temp.

2-8°C

storage temp.

15-25°C

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.[1][2]
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 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.

Recommended products

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.

related product

Product No.
Description
Pricing

Pictograms

Exclamation mark
GHS07

Signal Word

Warning

Hazard Statements

H319

Precautionary Statements

P305 + P351 + P338

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

    • Certificates of Analysis (COA)

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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
    View All Related Papers

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