8.17058

Acido maleico

EMPROVE^® ESSENTIAL, Ph. Eur., NF

• Sinonimo/i: Acido cis-Butenedioico, Acido tosilico
• Formula condensata: HO₂CCH=CHCO₂H
• Numero CAS: 110-16-7
• Peso molecolare: 116.07
• Beilstein: 605762
• Numero MDL: MFCD00063177
• Codice UNSPSC: 12352106
• Numero indice EU: 203-742-5

Proprietà

• agenzia: NF; Ph. Eur.
• Livello qualitativo: 500
• Tensione di vapore: <0.1 hPa ( 20 °C)
• Nome Commerciale: EMPROVE^® ESSENTIAL
• Saggio: 99.0-101.0% substance (anhydrous) basis
• Forma fisica: solid
• Potenza: 708 mg/kg LD₅₀, oral (Rat); 1560 mg/kg LD₅₀, skin (Rabbit)
• tecniche: API processing | cocrystal formation: suitable; API processing | salt formation: suitable
• pH: 1.3 (20 °C, 100 g/L in H₂O)
• Punto di fusione: 130-135 °C (lit.)
• Solubilità: 478.8 g/L
• Densità: 1.59 g/mL at 25 °C (lit.)
• Cationi in tracce: Fe: ≤5 ppm; V: ≤1 ppm; heavy metals (as Pb): ≤10 ppm
• applicazioni: liquid formulation; pharmaceutical; semi-solid formulation; solid formulation
• Temperatura di conservazione: 15-25°C
• Stringa SMILE: 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-; VZCYOOQTPOCHFL-UPHRSURJSA-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

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.

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: GHS05,GHS07
• Avvertenze: Danger
• Indicazioni di pericolo: H302 + H312,H314,H317,H335
• Consigli di prudenza: P260 - P271 - P280 - P301 + P312 - P303 + P361 + P353 - P305 + P351 + P338
• Classi di pericolo: Acute Tox. 4 Dermal - Acute Tox. 4 Oral - Eye Dam. 1 - Skin Corr. 1 - Skin Sens. 1 - STOT SE 3
• Organi bersaglio: Respiratory system
• Codice della classe di stoccaggio: 8A - Combustible corrosive hazardous materials
• Classe di pericolosità dell'acqua (WGK): WGK 1