1.37003

Citric acid monohydrate

crystalline, EMPROVE^® EXPERT, Ph. Eur., BP, ChP, JP, USP

• Synonym(s): 2-Hydroxypropane-1,2,3-tricarboxylic acid, Hydroxytricarballylic acid
• Linear Formula: HOC(COOH)(CH₂COOH)₂ · H₂O
• CAS Number: 5949-29-1
• Molecular Weight: 210.14
• Beilstein: 4018641
• MDL number: MFCD00149972
• UNSPSC Code: 12352106
• EC Index Number: 201-069-1

Properties

• Agency: BP; ChP; JP; Ph. Eur.; USP
• Quality Level: 500
• vapor pressure: <1 Pa ( 25 °C)
• description: cryst. EMPROVE^® EXPERT Ph Eur,BP,ChP,JP,USP
• product line: EMPROVE^® EXPERT
• form: crystalline; solid
• feature: RNase and DNase free
• pH: 1.85 (25 °C, 50 g/L in H₂O)
• pKa: (1) 3.13, (2) 4.76, (3) 6.4
• mp: 135-152 °C
• transition temp: flash point 173.9 °C
• solubility: 880 g/L
• density: 1.54 g/cm³ at 20 °C
• application(s): liquid formulation; parenterals; pharma/biopharma processes; pharmaceutical
• storage temp.: 15-25°C
• SMILES string: OC(CC(O)(C(O)=O)CC(O)=O)=O.O
• InChI: 1S/C6H8O7.H2O/c7-3(8)1-6(13,5(11)12)2-4(9)10;/h13H,1-2H2,(H,7,8)(H,9,10)(H,11,12);1H2
• InChI key: YASYEJJMZJALEJ-UHFFFAOYSA-N

Description

General description

Finding the right excipient that matches your needs as well as regulatory demands can be a complicated challenge. 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

Citric acid anhydrous is typically used as a citrate buffer system component for biomolecule downstream chromatography steps or final liquid formulation.
Due to its low microbial and endotoxin limits, Citric acid anhydrous Emprove^® Expert is especially suitable for high-risk 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: GHS07
• Signal Word: Warning
• Hazard Statements: H319,H335
• Precautionary Statements: P261 - P264 - P271 - P280 - P304 + P340 + P312 - P305 + P351 + P338
• Hazard Classifications: Eye Irrit. 2 - STOT SE 3
• Target Organs: Respiratory system
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 1
• Flash Point(F): 345.0 °F - closed cup
• Flash Point(C): 173.9 °C - closed cup