8.17058

Maleic acid

EMPROVE^® ESSENTIAL, Ph. Eur., NF

• Synonym(s): cis-Butenedioic acid, Toxilic acid
• Linear Formula: HO₂CCH=CHCO₂H
• CAS Number: 110-16-7
• Molecular Weight: 116.07
• Beilstein: 605762
• MDL number: MFCD00063177
• UNSPSC Code: 12352106
• EC Index Number: 203-742-5

Properties

• Agency: NF; Ph. Eur.
• Quality Level: 500
• vapor pressure: <0.1 hPa ( 20 °C)
• product line: EMPROVE^® ESSENTIAL
• Assay: 99.0-101.0% substance (anhydrous) basis
• form: solid
• potency: 708 mg/kg LD₅₀, oral (Rat); 1560 mg/kg LD₅₀, skin (Rabbit)
• technique(s): API processing | cocrystal formation: suitable; API processing | salt formation: suitable
• pH: 1.3 (20 °C, 100 g/L in H₂O)
• mp: 130-135 °C (lit.)
• solubility: 478.8 g/L
• density: 1.59 g/mL at 25 °C (lit.)
• cation traces: Fe: ≤5 ppm; V: ≤1 ppm; heavy metals (as Pb): ≤10 ppm
• application(s): liquid formulation; pharmaceutical; semi-solid formulation; solid formulation
• storage temp.: 15-25°C
• SMILES string: 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-
• InChI key: VZCYOOQTPOCHFL-UPHRSURJSA-N

Description

General description

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.

Application

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.

Legal Information

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

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

Safety Information

• Pictograms: GHS05,GHS07
• Signal Word: Danger
• Hazard Statements: H302 + H312,H314,H317,H335
• Precautionary Statements: P260 - P271 - P280 - P301 + P312 - P303 + P361 + P353 - P305 + P351 + P338
• Hazard Classifications: Acute Tox. 4 Dermal - Acute Tox. 4 Oral - Eye Dam. 1 - Skin Corr. 1 - Skin Sens. 1 - STOT SE 3
• Target Organs: Respiratory system
• Storage Class Code: 8A - Combustible corrosive hazardous materials
• WGK: WGK 1