1.00243

Citric acid monohydrate

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

• Synonim(y): 2-Hydroxypropane-1,2,3-tricarboxylic acid, Hydroxytricarballylic acid
• Wzór liniowy: HOC(COOH)(CH₂COOH)₂ · H₂O
• Numer CAS: 5949-29-1
• Masa cząsteczkowa: 210.14
• UNSPSC Code: 12352106
• EC Index Number: 201-069-1
• E Number: E330
• MDL number: MFCD00149972
• Beilstein/REAXYS Number: 4018641

Właściwości

• Nazwa produktu: Citric acid monohydrate, powder, EMPROVE^® ESSENTIAL, Ph. Eur., BP, ChP, JP, USP, FCC, E 330
• 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
• SMILES string: OC(CC(O)(C(O)=O)CC(O)=O)=O.O
• InChI key: YASYEJJMZJALEJ-UHFFFAOYSA-N
• agency: BP; ChP; JP; Ph. Eur.; USP
• reg. compliance: FCC
• vapor pressure: <1 Pa ( 25 °C)
• product line: EMPROVE^® ESSENTIAL
• form: fine powder; powder
• potency: 3000 mg/kg LD₅₀, oral (Rat)
• particle size: (see specification)
• 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
• Quality Level: 500

Opis

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 powder Emprove^® Essential is citric acid present in its monohydrate, powder form.

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.

Legal Information

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

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

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Informacja o środkach bezpieczeństwa

• pictograms: GHS07
• signalword: Warning
• hcodes: H319,H335
• pcodes: P261 - P264 - P271 - P280 - P304 + P340 + P312 - P305 + P351 + P338
• Hazard Classifications: Eye Irrit. 2 - STOT SE 3
• target_organs: Respiratory system
• Klasa składowania: 11 - Combustible Solids
• wgk: WGK 1
• flash_point_f: 345.0 °F - closed cup
• flash_point_c: 173.9 °C - closed cup