1.00242

Citric acid monohydrate

crystalline, EMPROVE^® ESSENTIAL, Ph. Eur., BP, ChP, USP, FCC, E 330

• 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
• E Number: E330
• EC Index Number: 201-069-1

Properties

• Agency: BP; ChP; Ph. Eur.; USP
• Quality Level: 500
• reg. compliance: FCC
• vapor pressure: <1 Pa ( 25 °C)
• description: cryst. EMPROVE^® ESSENTIAL Ph Eur,BP,JP,USP,E 330,FCC
• product line: EMPROVE^® ESSENTIAL
• form: coarse powder; crystalline
• potency: 3000 mg/kg LD₅₀, oral (Rat)
• 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; ophthalmics; pharmaceutical; semi-solid formulation; solid formulation
• storage temp.: 2-30°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 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

Citric acid is typically used as pH adjuster, buffer agent or as antioxidant in pharmaceutical formulations. Its application range spans across different formulation types, including semi-solid dosage forms, liquid dosage forms such as solutions and solid dosage forms such as effervescent tablets or granules.
Citric acid monohydrate cryst. Emprove^® Essential is citric acid present in its crystalline monohydrate form.

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
• Flash Point(C): 173.9 °C