8.17058

Ácido maleico

EMPROVE^® ESSENTIAL, Ph. Eur., NF

• Sinônimo(s): Ácido cis-butenodioico, Ácido toxílico
• Fórmula linear: HO₂CCH=CHCO₂H
• Número CAS: 110-16-7
• Peso molecular: 116.07
• Beilstein: 605762
• Número MDL: MFCD00063177
• Código UNSPSC: 12352106
• Número do índice EC: 203-742-5

Propriedades

• Agency: NF; Ph. Eur.
• Nível de qualidade: 500
• pressão de vapor: <0.1 hPa ( 20 °C)
• linha de produto: EMPROVE^® ESSENTIAL
• Ensaio: 99.0-101.0% substance (anhydrous) basis
• forma: solid
• potência: 708 mg/kg LD₅₀, oral (Rat); 1560 mg/kg LD₅₀, skin (Rabbit)
• técnica(s): API processing | cocrystal formation: suitable; API processing | salt formation: suitable
• pH: 1.3 (20 °C, 100 g/L in H₂O)
• pf: 130-135 °C (lit.)
• solubilidade: 478.8 g/L
• densidade: 1.59 g/mL at 25 °C (lit.)
• traços de cátion: Fe: ≤5 ppm; V: ≤1 ppm; heavy metals (as Pb): ≤10 ppm
• aplicação(ões): liquid formulation; pharmaceutical; semi-solid formulation; solid formulation
• temperatura de armazenamento: 15-25°C
• cadeia de caracteres SMILES: OC(=O)\C=C/C(O)=O
• InChI: 1S/C4H4O4/c5-3(6)1-2-4(7)8/h1-2H,(H,5,6)(H,7,8)/b2-1-
• chave InChI: VZCYOOQTPOCHFL-UPHRSURJSA-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

Maleic acid is typically used as pH adjuster or buffer agent in pharmaceutical formulations. Maleic 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: GHS05,GHS07
• Palavra indicadora: Danger
• Frases de perigo: H302 + H312,H314,H317,H335
• Declarações de precaução: P260 - P271 - P280 - P301 + P312 - P303 + P361 + P353 - P305 + P351 + P338
• Classificações de perigo: Acute Tox. 4 Dermal - Acute Tox. 4 Oral - Eye Dam. 1 - Skin Corr. 1 - Skin Sens. 1 - STOT SE 3
• Órgãos-alvo: Respiratory system
• Código de classe de armazenamento: 8A - Combustible corrosive hazardous materials
• Classe de risco de água (WGK): WGK 1