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Merck

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:
Molecular Weight:
210.14
Beilstein:
4018641
MDL number:
UNSPSC Code:
12352106
E Number:
E330
EC Index Number:
201-069-1

Pricing and availability is not currently available.

Agency

BP
ChP
Ph. Eur.
USP

Quality Level

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

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This Item
1.002431.37003C2219000
agency

BP, Ph. Eur., ChP, USP

agency

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

agency

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

agency

EP Reference Standard

form

coarse powder, crystalline

form

fine powder

form

crystalline, solid

form

-

density

1.54 g/cm3 at 20 °C

density

1.54 g/cm3 at 20 °C

density

1.54 g/cm3 at 20 °C

density

-

solubility

880 g/L

solubility

880 g/L

solubility

880 g/L

solubility

-

product line

EMPROVE® ESSENTIAL

product line

EMPROVE® ESSENTIAL

product line

EMPROVE® EXPERT

product line

-

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

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)

345.0 °F - closed cup

Flash Point(C)

173.9 °C - closed cup


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. Four document types are included with an Emprove® Program subscription:

Material Qualification Dossier

Free of charge - Sign in to download

Quality Management Dossier (Open Access)

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Operational Excellence Dossier

Available by subscription or for a fee

Operational Excellence Dossier

Available by subscription or for a fee

Learn more about the benefits an Emprove® Program subscription can provide
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.

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