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Safety Information

1.00201

SAFC

Phenol

EMPROVE® ESSENTIAL, Ph. Eur., ChP, JP, USP

Pharma Manufacturing

Synonym(s):

Hydroxybenzene, Carbolic acid, Hydroxybenzene

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About This Item

Linear Formula:
C6H5OH
CAS Number:
108-95-2
Molecular Weight:
94.11
Beilstein:
969616
MDL number:
MFCD00002143
UNSPSC Code:
12352104
EC Index Number:
203-632-7

Agency

ChP
JP
Ph. Eur.
USP

Quality Level

500

vapor density

3.24 (vs air)

vapor pressure

0.09 psi ( 55 °C)
0.36 mmHg ( 20 °C)

product line

EMPROVE® ESSENTIAL

Assay

99.0-100.5% (bromatometric)

form

solid

autoignition temp.

1319 °F

expl. lim.

8.6 %

technique(s)

API processing | cocrystal formation: suitable

pH

5 (20 °C, 50 g/L in H2O)

bp

182 °C (lit.)

mp

40-42 °C (lit.)

transition temp

flash point 81 °C

density

1.071 g/mL at 25 °C (lit.)

application(s)

liquid formulation
pharma/biopharma processes
pharmaceutical

storage temp.

15-25°C

SMILES string

Oc1ccccc1

InChI

1S/C6H6O/c7-6-4-2-1-3-5-6/h1-5,7H

InChI key

ISWSIDIOOBJBQZ-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

Phenol is active against a wide range of microorganisms and is therefore used as a preservative in pharmaceutical formulations.

Legal Information

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

Disclaimer

The product is not intended for use as a biocide under global biocide regulations, including but not limited to US EPA′s Federal Insecticide Fungicide and Rodenticide Act, European Biocidal Products Regulation, Canada’s Pest Management Regulatory Agency, Turkey’s Biocidal Products Regulation, Korea’s Consumer Chemical Products and Biocide Safety Management Act (K-BPR) and others.

Signal Word

Danger

Hazard Classifications

Acute Tox. 3 Dermal - Acute Tox. 3 Inhalation - Acute Tox. 3 Oral - Aquatic Chronic 2 - Eye Dam. 1 - Muta. 2 - Skin Corr. 1B - STOT RE 2

Target Organs

Nervous system,Kidney,Liver,Skin

WGK

WGK 2

Regulatory Information

危险化学品

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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Articles

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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