1.00247

Citric acid

anhydrous fine-granular, 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
• Numer CAS: 77-92-9
• Masa cząsteczkowa: 192.12
• Beilstein: 782061
• Numer MDL: MFCD00011669
• Kod UNSPSC: 12352106
• Numer E: E330
• Numer indeksu EC: 201-069-1

Właściwości

• agency: BP; ChP; JP; Ph. Eur.; USP
• Poziom jakości: 500
• zgodność regionalna: FCC
• ciśnienie pary: <0.1 hPa ( 20 °C)
• linia produktu: EMPROVE^® ESSENTIAL
• Próba: 99.5-100.5% substance (anhydrous) basis (alkalimetric)
• Postać: coarse powder
• siła działania: 3000 mg/kg LD₅₀, oral (Rat)
• granice wybuchowości: 8 %, 65 °F
• pH: 1.7 (20 °C, 100 g/L in H₂O)
• pKa: (1) 3.13, (2) 4.76, (3) 6.4
• tw: 200 °C/1013 hPa (decomposition)
• mp: 153-159 °C (lit.)
• rozpuszczalność: water: 1330 g/L at 20 °C
• gęstość: 1.665 g/cm³ at 18 °C
• ślady kationów: Al: ≤0.2 ppm; As: ≤1 ppm; Hg: ≤1 ppm; Pb: ≤0.5 ppm; heavy metals (as Pb): ≤5 ppm
• Zastosowanie: liquid formulation; ophthalmics; pharmaceutical; semi-solid formulation; solid formulation
• temp. przechowywania: 2-30°C
• ciąg SMILES: OC(=O)CC(O)(CC(O)=O)C(O)=O
• 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)
• Klucz InChI: KRKNYBCHXYNGOX-UHFFFAOYSA-N

Opis

Opis ogólny

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.

Zastosowanie

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 anhydrous powder Emprove^® Essential is citric acid present in its water-free, fine granulated form.

Informacje prawne

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
• Hasło ostrzegawcze: Warning
• Zwroty wskazujące rodzaj zagrożenia: H319,H335
• Zwroty wskazujące środki ostrożności: P261 - P264 - P271 - P280 - P304 + P340 + P312 - P305 + P351 + P338
• Klasyfikacja zagrożeń: Eye Irrit. 2 - STOT SE 3
• Organy docelowe: Respiratory system
• Kod klasy składowania: 11 - Combustible Solids
• Klasa zagrożenia wodnego (WGK): WGK 1
• Temperatura zapłonu (°F): Not applicable
• Temperatura zapłonu (°C): Not applicable