1.00383

DL-Malic acid

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

• Sinônimo(s): DL-Malic acid, DL-Hydroxysuccinic acid, Hydroxybutanedioic acid
• Fórmula empírica (Notação de Hill): C₄H₆O₅
• Número CAS: 6915-15-7
• Peso molecular: 134.09
• Número MDL: MFCD00064212
• Código UNSPSC: 12352106
• Número E: E296
• Número do índice EC: 230-022-8

Propriedades

• Agency: NF; Ph. Eur.
• Nível de qualidade: 500
• conformidade reg.: FCC
• linha de produto: EMPROVE^® ESSENTIAL
• Formulário: solid
• temperatura de autoignição: 349 °C
• potência: >3200 mg/kg LD₅₀, oral (Rat)
• técnica(s): API processing | cocrystal formation: suitable; API processing | salt formation: suitable
• pH: 2.3 (20 °C, 10 g/L in H₂O)
• pf: 128-132 °C
• temperatura de transição: flash point 203 °C
• solubilidade: 558 g/L
• densidade: 1.60 g/cm³ at 20 °C
• aplicação(ões): pharmaceutical; solid formulation
• temperatura de armazenamento: 15-25°C
• cadeia de caracteres SMILES: [O-]C(=O)C(O)CC(=O)[O-].[H+].[H+]
• InChI: 1S/C4H6O5/c5-2(4(8)9)1-3(6)7/h2,5H,1H2,(H,6,7)(H,8,9)
• chave InChI: BJEPYKJPYRNKOW-UHFFFAOYSA-N

Descrição

Descrição geral

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.

Aplicação

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.

Informações legais

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

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

Informações de segurança

• Pictogramas: GHS07
• Palavra indicadora: Warning
• Frases de perigo: H319
• Declarações de precaução: P264 - P280 - P305 + P351 + P338 - P337 + P313
• Classificações de perigo: Eye Irrit. 2
• Código de classe de armazenamento: 11 - Combustible Solids
• Classe de risco de água (WGK): WGK 1
• Ponto de fulgor (°F): 397.4 °F
• Ponto de fulgor (°C): 203 °C