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Merck

1.37002

クエン酸

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

別名:

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

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この商品について

化学式:
HOC(COOH)(CH2COOH)2
CAS番号:
分子量:
192.12
EC Index Number:
201-069-1
UNSPSC Code:
12352106
Beilstein/REAXYS Number:
782061
MDL number:
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Quality Level

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

signalword

Warning

hcodes

Hazard Classifications

Eye Irrit. 2 - STOT SE 3

target_organs

Respiratory system

保管分類

11 - Combustible Solids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable



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資料

Instead of addressing API solubility during formulation, tackle it early during development. Read about the various methods for API processing.

関連コンテンツ

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





グローバルトレードアイテム番号

カタログ番号GTIN
1.37002.901204027269077419
1.37002.100004027269358235
1.37002.500004027269061890
1.37002.902904027269061418