1.00383

DL-Malic acid

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

• 別名: DL-Malic acid, DL-Hydroxysuccinic acid, Hydroxybutanedioic acid
• 実験式（ヒル表記法）: C₄H₆O₅
• CAS番号: 6915-15-7
• 分子量: 134.09
• MDL番号: MFCD00064212
• UNSPSCコード: 12352106
• E番号: E296
• EC Index Number: 230-022-8

特性

• 認証: NF; Ph. Eur.
• 品質水準: 500
• 法規制遵守: FCC
• 製品種目: EMPROVE^® ESSENTIAL
• フォーム: solid
• 自己発火温度: 349 °C
• 有効性: >3200 mg/kg LD₅₀, oral (Rat)
• テクニック: API processing | cocrystal formation: suitable; API processing | salt formation: suitable
• pH: 2.3 (20 °C, 10 g/L in H₂O)
• mp: 128-132 °C
• 転移温度: flash point 203 °C
• 溶解性: 558 g/L
• 密度: 1.60 g/cm³ at 20 °C
• アプリケーション: pharmaceutical; solid formulation
• 保管温度: 15-25°C
• SMILES記法: [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

詳細

詳細

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.

アプリケーション

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.

法的情報

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

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

安全性情報

• ピクトグラム: GHS07
• シグナルワード: Warning
• 危険有害性情報: H319
• 注意書き: P264 - P280 - P305 + P351 + P338 - P337 + P313
• 危険有害性の分類: Eye Irrit. 2
• 保管分類コード: 11 - Combustible Solids
• WGK: WGK 1
• 引火点(°F): 397.4 °F
• 引火点(℃): 203 °C