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Merck

1.00241

SAFC

Citric acid

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

의약품 제조

동의어(들):

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

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About This Item

Linear Formula:
HOC(COOH)(CH2COOH)2
CAS Number:
Molecular Weight:
192.12
Beilstein:
782061
MDL number:
UNSPSC 코드:
12352106
E 번호:
E330
EC 인덱스 번호:
201-069-1

Agency

BP
JP
Ph. Eur.
USP

Quality Level

규정 준수

FCC

vapor pressure

<0.1 hPa ( 20 °C)

제품 라인

EMPROVE® ESSENTIAL

분석

99.5-100.5% substance (anhydrous) basis (alkalimetric)

형태

fine powder

효능

3000 mg/kg LD50, oral (Rat)

expl. lim.

8 %, 65 °F

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

1330 g/L

density

1.665 g/cm3 at 18 °C

양이온 미량물

Al: ≤0.2 ppm
As: ≤1 ppm
Hg: ≤1 ppm
Pb: ≤0.5 ppm
heavy metals (as Pb): ≤5 ppm

응용 분야

liquid formulation
ophthalmics
pharmaceutical
semi-solid formulation
solid formulation

저장 온도

2-30°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

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일반 설명

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.

애플리케이션

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 anhydrous powder Emprove® Essential is citric acid present in its water-free, powder form.

법적 정보

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

픽토그램

Exclamation mark

신호어

Warning

유해 및 위험 성명서

Hazard Classifications

Eye Irrit. 2 - STOT SE 3

표적 기관

Respiratory system

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point (°F)

Not applicable

Flash Point (°C)

Not applicable


시험 성적서(COA)

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