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8.17058

SAFC

Maleic acid

EMPROVE® ESSENTIAL, Ph. Eur., NF

Pharma Manufacturing

Synonym(s):

cis-Butenedioic acid, Toxilic acid

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About This Item

Linear Formula:
HO2CCH=CHCO2H
CAS Number:
110-16-7
Molecular Weight:
116.07
Beilstein/REAXYS Number:
605762
MDL number:
MFCD00063177
UNSPSC Code:
12352106
EC Index Number:
203-742-5

agency

NF
Ph. Eur.

Quality Level

500

vapor pressure

<0.1 hPa ( 20 °C)

product line

EMPROVE® ESSENTIAL

assay

99.0-101.0% substance (anhydrous) basis

form

solid

potency

708 mg/kg LD50, oral (Rat)
1560 mg/kg LD50, skin (Rabbit)

technique(s)

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

pH

1.3 (20 °C, 100 g/L in H2O)

mp

130-135 °C (lit.)

solubility

478.8 g/L

density

1.59 g/mL at 25 °C (lit.)

cation traces

Fe: ≤5 ppm
V: ≤1 ppm
heavy metals (as Pb): ≤10 ppm

application(s)

liquid formulation
pharmaceutical
semi-solid formulation
solid formulation

storage temp.

15-25°C

SMILES string

OC(=O)\C=C/C(O)=O

InChI

1S/C4H4O4/c5-3(6)1-2-4(7)8/h1-2H,(H,5,6)(H,7,8)/b2-1-

InChI key

VZCYOOQTPOCHFL-UPHRSURJSA-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

Maleic acid is typically used as pH adjuster or buffer agent in pharmaceutical formulations. Maleic 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

CorrosionExclamation mark
GHS05,GHS07

signalword

Danger

Hazard Classifications

Acute Tox. 4 Dermal - Acute Tox. 4 Oral - Eye Dam. 1 - Skin Corr. 1 - Skin Sens. 1 - STOT SE 3

target_organs

Respiratory system

Storage Class

8A - Combustible, corrosive hazardous materials

wgk_germany

WGK 1

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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