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1.37002

Citric acid

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

Synonym(s):

2-Hydroxypropane-1,2,3-tricarboxylic acid, Hydroxytricarballylic acid

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About This Item

Linear Formula:
HOC(COOH)(CH2COOH)2
CAS Number:
77-92-9
Molecular Weight:
192.12
EC Index Number:
201-069-1
UNSPSC Code:
12352106
Beilstein/REAXYS Number:
782061
MDL number:
MFCD00011669
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Quality Level

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

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

application(s)

liquid formulation
parenterals
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

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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pictograms

Exclamation mark
GHS07

signalword

Warning

hcodes

H319,H335

Hazard Classifications

Eye Irrit. 2 - STOT SE 3

target_organs

Respiratory system

Storage Class

11 - Combustible Solids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Formulation

Learn more on mAb subcutaneous or intravenous formulation, and the relevant associated products, including excipients.

Global Trade Item Number

SKUGTIN
137002100004027269358235
137002901204027269077419
137002000104027269358273
137002500004027269061890
137002902904027269061418