1.00383

DL-Malic acid

EMPROVE^® ESSENTIAL, Ph. Eur., NF, FCC, E 296

• Synonym(s): DL-Malic acid, DL-Hydroxysuccinic acid, Hydroxybutanedioic acid
• Empirical Formula (Hill Notation): C₄H₆O₅
• CAS Number: 6915-15-7
• Molecular Weight: 134.09
• MDL number: MFCD00064212
• UNSPSC Code: 12352106
• E Number: E296
• EC Index Number: 230-022-8

Properties

• Agency: NF; Ph. Eur.
• Quality Level: 500
• reg. compliance: FCC
• product line: EMPROVE^® ESSENTIAL
• form: solid
• autoignition temp.: 349 °C
• potency: >3200 mg/kg LD₅₀, oral (Rat)
• technique(s): API processing | cocrystal formation: suitable; API processing | salt formation: suitable
• pH: 2.3 (20 °C, 10 g/L in H₂O)
• mp: 128-132 °C
• transition temp: flash point 203 °C
• solubility: 558 g/L
• density: 1.60 g/cm³ at 20 °C
• application(s): pharmaceutical; solid formulation
• storage temp.: 15-25°C
• InChI: 1S/C4H6O5/c5-2(4(8)9)1-3(6)7/h2,5H,1H2,(H,6,7)(H,8,9)
• InChI key: BJEPYKJPYRNKOW-UHFFFAOYSA-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

Malic acid is typically applied as acidulant and pH adjuster as well as taste modifier in pharmaceutical formulations and food. In addition, it has antioxidant properties.
DL-Malic acid Emprove^® Essential is mainly used in highly regulated pharmaceutical applications.

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): 397.4 °F
• Flash Point(C): 203 °C