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8.17073

SAFC

Fumaric acid

EMPROVE® ESSENTIAL, NF, JPE

Pharma Manufacturing

Synonym(s):

Fumaric acid, trans-1,2-Ethylentricarboxylic acid

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About This Item

Empirical Formula (Hill Notation):
C4H4O4
CAS Number:
110-17-8
Molecular Weight:
116.07
MDL number:
MFCD00002700
UNSPSC Code:
12352106
EC Index Number:
203-743-0

Agency

JPE
NF

Quality Level

500

vapor pressure

<0.001 hPa ( 20 °C)

product line

EMPROVE® ESSENTIAL

form

solid

autoignition temp.

375 °C

potency

9300 mg/kg LD50, oral (Rat)
20000 mg/kg LD50, skin (Rabbit)

technique(s)

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

pH

2.1 (20 °C, 4.9 g/L in H2O)

bp

290 °C/1013 hPa (sublimed)

mp

287 °C

transition temp

flash point 273 °C

solubility

4.9 g/L

density

1.64 g/cm3 at 20 °C

application(s)

liquid formulation
pharmaceutical
solid formulation

storage temp.

15-25°C

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

Related Categories

General description

Finding the right excipient that matches your needs as well as regulatory demands can be a complicated challenge in formulation. With our application know-how and regulatory expertise, we support you in every step of development, scale-up, and production.
As part of our EMPROVE® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

Application

Fumaric acid is a commonly used ingredient in both food and pharmaceutical applications. In pharmaceutical applications, fumaric acid has been used primarily as a pH modifier.

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

Pictograms

Exclamation mark
GHS07

Signal Word

Warning

Hazard Statements

H319

Hazard Classifications

Eye Irrit. 2

WGK

WGK 1

Flash Point(F)

523.4 °F

Flash Point(C)

273 °C

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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