1.00383

DL-Malic acid

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

• 동의어(들): DL-Malic acid, DL-Hydroxysuccinic acid, Hydroxybutanedioic acid
• 실험식(Hill 표기법): C₄H₆O₅
• CAS Number: 6915-15-7
• Molecular Weight: 134.09
• MDL number: MFCD00064212
• UNSPSC 코드: 12352106
• E 번호: E296
• EC 인덱스 번호: 230-022-8

속성

• Agency: NF; Ph. Eur.
• Quality Level: 500
• 규정 준수: FCC
• 제품 라인: EMPROVE^® ESSENTIAL
• 양식: solid
• autoignition temp.: 349 °C
• 효능: >3200 mg/kg LD₅₀, oral (Rat)
• 기술: API processing | cocrystal formation: suitable; API processing | salt formation: suitable
• pH: 2.3 (20 °C, 10 g/L in H₂O)
• mp: 128-132 °C
• 전이 온도: flash point 203 °C
• solubility: 558 g/L
• density: 1.60 g/cm³ at 20 °C
• 응용 분야: pharmaceutical; solid formulation
• 저장 온도: 15-25°C
• SMILES string: [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)
• InChI key: BJEPYKJPYRNKOW-UHFFFAOYSA-N

설명

일반 설명

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.

애플리케이션

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.

법적 정보

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

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

안전성 정보

• 픽토그램: GHS07
• 신호어: Warning
• 유해 및 위험 성명서: H319
• 예방조치 성명서: 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