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Safety Information

1.00383

SAFC

DL-Malic acid

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

Pharma Manufacturing

Synonym(s):

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

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About This Item

Empirical Formula (Hill Notation):
C4H6O5
CAS Number:
6915-15-7
Molecular Weight:
134.09
MDL number:
MFCD00064212
UNSPSC Code:
12352106
E Number:
E296
EC Index Number:
230-022-8

Agency

NF
Ph. Eur.

Quality Level

500

reg. compliance

FCC

product line

EMPROVE® ESSENTIAL

form

solid

autoignition temp.

349 °C

potency

>3200 mg/kg LD50, oral (Rat)

technique(s)

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

pH

2.3 (20 °C, 10 g/L in H2O)

mp

128-132 °C

transition temp

flash point 203 °C

solubility

558 g/L

density

1.60 g/cm3 at 20 °C

application(s)

pharmaceutical
solid formulation

storage temp.

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

Related Categories

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

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.

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

Hazard Classifications

Eye Irrit. 2

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

397.4 °F

Flash Point(C)

203 °C

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.

ISHL Indicated Name

Substances Subject to be Indicated Names

ISHL Notified Names

Substances Subject to be Notified Names

JAN Code

1003839999:
CO1E1003839025:
1003839025BWT:
CO1I1003839025:
1003839025:
1003830000:

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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