1.37002

Citric acid

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

• Synonim(y): 2-Hydroxypropane-1,2,3-tricarboxylic acid, Hydroxytricarballylic acid
• Wzór liniowy: HOC(COOH)(CH₂COOH)₂
• Numer CAS: 77-92-9
• Masa cząsteczkowa: 192.12
• EC Index Number: 201-069-1
• UNSPSC Code: 12352106
• Beilstein/REAXYS Number: 782061
• MDL number: MFCD00011669

Właściwości

• Quality Segment: 500
• agency: BP, ChP, JP, Ph. Eur., USP
• vapor pressure: <0.1 hPa ( 20 °C)
• product line: EMPROVE^® EXPERT
• assay: 99.5-100.5% substance (anhydrous) basis (alkalimetric)
• form: fine powder, solid
• feature: RNase and DNase free
• expl. lim.: 8 %, 65 °F
• technique(s): API processing | cocrystal formation: suitable, API processing | salt formation: suitable, pH adjustment: suitable
• impurities: endotoxins, low
• pH: 1.7 (20 °C, 100 g/L in H₂O)
• pKa: (1) 3.13, (2) 4.76, (3) 6.4
• bp: 200 °C/1013 hPa (decomposition)
• mp: 153-159 °C (lit.)
• solubility: water: 1330 g/L at 20 °C
• density: 1.665 g/cm³ at 18 °C
• cation traces: Al: ≤0.2 ppm, Fe: ≤3 ppm, Pb: ≤2 ppm, heavy metals (as Pb): ≤10 ppm
• SMILES string: OC(=O)CC(O)(CC(O)=O)C(O)=O
• application(s): biomolecule formulation; downstream processes; liquid formulation; mRNA manufacturing; parenterals; pharma/biopharma processes; pharmaceutical; viral inactivation
• storage temp.: 15-25°C
• InChI: 1S/C6H8O7/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)
• InChI key: KRKNYBCHXYNGOX-UHFFFAOYSA-N

Opis

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

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Informacja o środkach bezpieczeństwa

• Piktogramy: GHS07
• Słowo ostrzegawcze: Warning
• Kody zagrożeń: H319,H335
• Ostrzeżenia: P261 - P264 - P271 - P280 - P304 + P340 + P312 - P305 + P351 + P338
• Hazard Classifications: Eye Irrit. 2 - STOT SE 3
• Narządy docelowe: Respiratory system
• Klasa składowania: 11 - Combustible Solids
• Co się dzieje?: WGK 1
• Temperatura zapłonu (°F): Not applicable
• Temperatura zapłonu (°C): Not applicable