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1.00242

SAFC

Citric acid monohydrate

crystalline, EMPROVE® ESSENTIAL, Ph. Eur., BP, ChP, USP, FCC, E 330

Pharma Manufacturing

Synonym(s):

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

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About This Item

Linear Formula:
HOC(COOH)(CH2COOH)2 · H2O
CAS Number:
5949-29-1
Molecular Weight:
210.14
Beilstein/REAXYS Number:
4018641
MDL number:
MFCD00149972
UNSPSC Code:
12352106
E Number:
E330
EC Index Number:
201-069-1

agency

BP
ChP
Ph. Eur.
USP

Quality Level

500

reg. compliance

FCC

vapor pressure

<1 Pa ( 25 °C)

description

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

product line

EMPROVE® ESSENTIAL

form

coarse powder
crystalline

potency

3000 mg/kg LD50, oral (Rat)

pH

1.85 (25 °C, 50 g/L in H2O)

pKa 

(1) 3.13, (2) 4.76, (3) 6.4

mp

135-152 °C

transition temp

flash point 173.9 °C

solubility

880 g/L

density

1.54 g/cm3 at 20 °C

application(s)

liquid formulation
ophthalmics
pharmaceutical
semi-solid formulation
solid formulation

storage temp.

2-30°C

SMILES string

OC(CC(O)(C(O)=O)CC(O)=O)=O.O

InChI

1S/C6H8O7.H2O/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);1H2

InChI key

YASYEJJMZJALEJ-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 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 monohydrate cryst. Emprove® Essential is citric acid present in its crystalline monohydrate 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
GHS07

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

345.0 °F - closed cup

flash_point_c

173.9 °C - closed cup

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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