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Merck
CN

1.00383

SAFC

DL-苹果酸

EMPROVE® ESSENTIAL, Ph. Eur., NF, FCC, E 296

制药生产

别名:

DL-Malic acid, DL-Hydroxysuccinic acid, Hydroxybutanedioic acid

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About This Item

经验公式(希尔记法):
C4H6O5
CAS号:
分子量:
134.09
MDL编号:
UNSPSC代码:
12352106
E编号:
E296
EC索引号:
230-022-8

Agency

NF
Ph. Eur.

质量水平

管理合规性

FCC

产品线

EMPROVE® ESSENTIAL

形式

solid

自燃温度

349 °C

效能

>3200 mg/kg LD50, oral (Rat)

技术

API processing | cocrystal formation: suitable
API processing | salt formation: suitable

pH值(酸碱度)

2.3 (20 °C, 10 g/L in H2O)

mp

128-132 °C

转变温度

flash point 203 °C

溶解性

558 g/L

密度

1.60 g/cm3 at 20 °C

应用

pharmaceutical
solid formulation

储存温度

15-25°C

InChI

1S/C4H6O5/c5-2(4(8)9)1-3(6)7/h2,5H,1H2,(H,6,7)(H,8,9)

InChI key

BJEPYKJPYRNKOW-UHFFFAOYSA-N

一般描述

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.

应用

Malic acid is typically applied as acidulant and pH adjuster as well as taste modifier in pharmaceutical formulations and food. In addition, it has antioxidant properties.
DL-Malic acid Emprove® Essential is mainly used in highly regulated pharmaceutical applications.

法律信息

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

象形图

Exclamation mark

警示用语:

Warning

危险声明

危险分类

Eye Irrit. 2

WGK

WGK 1

闪点(°F)

397.4 °F

闪点(°C)

203 °C


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