MilliporeSigma

1.00241

SAFC

Citric acid

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

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Synonym(s):
2-Hydroxypropane-1,2,3-tricarboxylic acid, Hydroxytricarballylic acid
Linear Formula:
HOC(COOH)(CH2COOH)2
CAS Number:
Molecular Weight:
192.12
Beilstein/REAXYS Number:
782061
MDL number:
E Number:
E330
EC Index Number:
201-069-1

agency

BP
JP
Ph. Eur.
USP

Quality Level

reg. compliance

FCC

vapor pressure

<0.1 hPa ( 20 °C)

product line

EMPROVE® ESSENTIAL

assay

99.5-100.5% substance (anhydrous) basis (alkalimetric)

form

fine powder

potency

3000 mg/kg LD50, oral (Rat)

expl. lim.

8 %, 65 °F

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

1330 g/L

density

1.665 g/cm3 at 18 °C

cation traces

Al: ≤0.2 ppm
As: ≤1 ppm
Hg: ≤1 ppm
Pb: ≤0.5 ppm
heavy metals (as Pb): ≤5 ppm

application(s)

liquid formulation
ophthalmics
pharmaceutical
semi-solid formulation
solid formulation

storage temp.

2-30°C

SMILES string

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)

InChI key

KRKNYBCHXYNGOX-UHFFFAOYSA-N

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Citric acid anhydrous powder, EMPROVE&#174; ESSENTIAL, Ph. Eur., BP, JP, USP, FCC, E 330

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Citric acid anhydrous, European Pharmacopoeia (EP) Reference Standard

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Quality Level

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Quality Level

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Quality Level

-

Quality Level

300

agency

BP, Ph. Eur., JP, USP

agency

BP, ChP, JP, Ph. Eur., USP

agency

EP reference standard

agency

-

form

fine powder

form

coarse powder

form

-

form

-

solubility

1330 g/L

solubility

water: 1330 g/L at 20 °C

solubility

-

solubility

-

pH

1.7 (20 °C, 100 g/L in H2O)

pH

1.7 (20 °C, 100 g/L in H2O)

pH

-

pH

-

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

Legal Information

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

pictograms

Exclamation mark

signalword

Warning

Hazard Classifications

Eye Irrit. 2 - STOT SE 3

target_organs

Respiratory system

Storage Class

11 - Combustible Solids

wgk_germany

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable


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