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Merck

1.00243

SAFC

Citric acid monohydrate

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

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:
4018641
MDL number:
MFCD00149972
UNSPSC Code:
12352106
E Number:
E330
EC Index Number:
201-069-1

Key Documents

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Agency

BP
ChP
JP
Ph. Eur.
USP

Quality Level

500

reg. compliance

FCC

vapor pressure

<1 Pa ( 25 °C)

product line

EMPROVE® ESSENTIAL

form

fine powder
powder

potency

3000 mg/kg LD50, oral (Rat)

particle size

(see specification)

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 powder Emprove® Essential is citric acid present in its monohydrate, 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
GHS07

Signal Word

Warning

Hazard Statements

H319,H335

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

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.

JAN Code

CO1E1002439025:
1002430000:
1002431000:
1002439999:
1002431000BWT:
CO1E1002439029:
1002439028:
1002439025:
1002439026:
CO1E1002431000:
1002439029:

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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Global Trade Item Number

SKUGTIN
1.00243.100004022536003351
1.00243.902504022536003375
1.00243.902604027269164522
1.00243.902904022536939759