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Key Documents

1.00681

SAFC

Succinic acid

crystalline, EMPROVE® ESSENTIAL, ChP, NF, JPE, ACS

Pharma Manufacturing

Synonym(s):

Butanedioic acid

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About This Item

Linear Formula:
HOOCCH2CH2COOH
CAS Number:
Molecular Weight:
118.09
Beilstein:
1754069
MDL number:
UNSPSC Code:
12352106
EC Index Number:
203-740-4

grade

ACS reagent

Quality Level

Agency

ChP
JPE
NF

product line

EMPROVE® ESSENTIAL

Assay

99.0-100.5% (HPLC)

form

crystalline
solid

autoignition temp.

470 °C

technique(s)

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

bp

235 °C (lit.)
235 °C/1013 hPa

mp

184-186 °C (lit.)

transition temp

flash point 206 °C

solubility

58 g/L

density

1.56 g/cm3 at 20 °C

anion traces

chloride (Cl-): ≤0.001%
phosphate (PO43-): ≤0.001%
sulfate (SO42-): ≤0.003%

cation traces

As: ≤0.0002%
Fe: ≤5 ppm
heavy metals (as Pb): ≤0.0020%
heavy metals (as Pb): ≤5 ppm

application(s)

liquid formulation
pharma/biopharma processes
pharmaceutical
solid formulation

storage temp.

2-30°C

SMILES string

OC(=O)CCC(O)=O

InChI

1S/C4H6O4/c5-3(6)1-2-4(7)8/h1-2H2,(H,5,6)(H,7,8)

InChI key

KDYFGRWQOYBRFD-UHFFFAOYSA-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

Succinic acid is a commonly used ingredient in pharmaceutical applications. In such applications it has been used primarily for solid oral dosage forms.

Legal Information

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

Pictograms

Corrosion

Signal Word

Danger

Hazard Statements

Precautionary Statements

Hazard Classifications

Eye Dam. 1

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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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