8.17073

Fumaric acid

EMPROVE^® ESSENTIAL, NF, JPE

• Synonym(s): Fumaric acid, trans-1,2-Ethylentricarboxylic acid
• 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

Properties

• 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

Description

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

Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H319
• Precautionary Statements: P264 - P280 - P305 + P351 + P338 - P337 + P313
• Hazard Classifications: Eye Irrit. 2
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 1
• Flash Point(F): 523.4 °F
• Flash Point(C): 273 °C