1.00383

DL-Malic acid

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

• Sinonimo/i: DL-Malic acid, DL-Hydroxysuccinic acid, Hydroxybutanedioic acid
• Formula empirica (notazione di Hill): C₄H₆O₅
• Numero CAS: 6915-15-7
• Peso molecolare: 134.09
• Numero MDL: MFCD00064212
• Codice UNSPSC: 12352106
• Numero E: E296
• Numero indice EU: 230-022-8

Proprietà

• agenzia: NF; Ph. Eur.
• Livello qualitativo: 500
• Conformità normativa: FCC
• Nome Commerciale: EMPROVE^® ESSENTIAL
• Forma fisica: solid
• Temp. autoaccensione: 349 °C
• Potenza: >3200 mg/kg LD₅₀, oral (Rat)
• tecniche: API processing | cocrystal formation: suitable; API processing | salt formation: suitable
• pH: 2.3 (20 °C, 10 g/L in H₂O)
• Punto di fusione: 128-132 °C
• Temp. transizione: flash point 203 °C
• Solubilità: 558 g/L
• Densità: 1.60 g/cm³ at 20 °C
• applicazioni: pharmaceutical; solid formulation
• Temperatura di conservazione: 15-25°C
• InChI: 1S/C4H6O5/c5-2(4(8)9)1-3(6)7/h2,5H,1H2,(H,6,7)(H,8,9); BJEPYKJPYRNKOW-UHFFFAOYSA-N

Descrizione

Descrizione generale

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.

Applicazioni

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.

Note legali

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

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

Informazioni sulla sicurezza

• Pittogrammi: GHS07
• Avvertenze: Warning
• Indicazioni di pericolo: H319
• Consigli di prudenza: P264 - P280 - P305 + P351 + P338 - P337 + P313
• Classi di pericolo: Eye Irrit. 2
• Codice della classe di stoccaggio: 11 - Combustible Solids
• Classe di pericolosità dell'acqua (WGK): WGK 1
• Punto d’infiammabilità (°F): 397.4 °F
• Punto d’infiammabilità (°C): 203 °C