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1.00662

SAFC

Sorbic acid

EMPROVE® ESSENTIAL, Ph. Eur., BP, ChP, NF, FCC, E 200

Pharma Manufacturing

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Synonym(s):
Sorbic acid, 2,4-Hexadienic acid
Empirical Formula (Hill Notation):
C6H8O2
CAS Number:
110-44-1
Molecular Weight:
112.13
MDL number:
MFCD00002703
UNSPSC Code:
12352106
E Number:
E200
EC Index Number:
203-768-7

Agency

BP
ChP
NF
Ph. Eur.

Quality Level

500

reg. compliance

FCC

vapor pressure

0.00018 hPa ( 20 °C)

product line

EMPROVE® ESSENTIAL

Assay

99.0-101.0% substance (anhydrous) basis (acidimetric)

form

solid

autoignition temp.

>130 °C

technique(s)

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

pH

3.3 (20 °C, 1.6 g/L in H2O)

bp

160-260 °C/1013 hPa (decomposition)

mp

120-150 °C

solubility

1.6 g/L

density

1.2 g/cm3 at 20 °C

cation traces

As: ≤0.0003%
Cd: ≤0.001%
Cu: ≤0.001%
Hg: ≤0.0001%
Pb: ≤0.0002%
Zn: ≤0.001%
heavy metals (as Pb): ≤0.0010%

application(s)

liquid formulation
ophthalmics
pharmaceutical
semi-solid formulation
solid formulation

storage temp.

15-25°C

InChI

1S/C6H8O2/c1-2-3-4-5-6(7)8/h2-5H,1H3,(H,7,8)/b3-2+,5-4+

InChI key

WSWCOQWTEOXDQX-MQQKCMAXSA-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

Sorbic acid is commonly used as a preservative in pharmaceutical formulations and cosmetics. It is also used as additive for the preservation of food.

Legal Information

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

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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Criteria for Selecting Preservatives Used in Liquid Formulation

Find key considerations for the selection and use of preservatives in a range of different therapeutic applications including topical, oral, transmucosal, inhalation, and otic, as well as injectables.

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