Merck
All Photos(3)

1.37002

SAFC

Citric acid

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

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

Agency

BP
ChP
JP
Ph. Eur.
USP

Quality Level

vapor pressure

<0.1 hPa ( 20 °C)

product line

EMPROVE® EXPERT

assay

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

form

fine powder
solid

expl. lim.

8 %, 65 °F

technique(s)

API processing | cocrystal formation: suitable
API processing | salt formation: suitable

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

application(s)

liquid formulation
pharma/biopharma processes
pharmaceutical

storage temp.

15-25°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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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.

Packaging

1 kg in PE bottle
3 kg in PE bottle (in carton)
5 kg in PE bottle
12 kg in PE bag (in PE pail)
25 kg in double PE bag (DPES in carton)
500 kg in big bag

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

Signal Word

Warning

Hazard Statements

Hazard Classifications

Eye Irrit. 2 - STOT SE 3

Target Organs

Respiratory system

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

ISHL Indicated Name

Not applicable

ISHL Notified Names

Not applicable

What is the Emprove® Program?

The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials.

Material Qualification Dossier

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Quality Management Dossier

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Operational Excellence Dossier

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Why are these documents unavailable?
Emprove® Dossiers contain information intended to support the registration process and risk assessment activities of pharmaceutical producers and contain confidential information. Please contact us if you would like access.

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

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