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Key Documents

Safety Information

1.37123

SAFC

Benzalkonium chloride

EMPROVE® EXPERT, Ph. Eur., JP, NF

Pharma Manufacturing

Synonym(s):

Alkylbenzyldimethylammonium chloride, Alkyldimethylbenzylammonium chloride

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About This Item

Linear Formula:
C6H5CH2N(CH3)2RCl (R=C8H17 to C18H37)
CAS Number:
Beilstein:
4062599
UBA Number:
12352200
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:

Agency

JP
NF
Ph. Eur.

Quality Level

product line

EMPROVE® EXPERT

form

viscous liquid

packaging

pkg of 1 kg

application(s)

liquid formulation
ophthalmics
parenterals
pharmaceutical
semi-solid formulation

storage temp.

15-25°C

SMILES string

[Cl-].CCCCCCCCCCCCCC[N+](C)(C)Cc1ccccc1

InChI

1S/C19H34N.ClH/c1-4-5-6-7-8-9-10-14-17-20(2,3)18-19-15-12-11-13-16-19;/h11-13,15-16H,4-10,14,17-18H2,1-3H3;1H/q+1;/p-1

InChI key

TTZLKXKJIMOHHG-UHFFFAOYSA-M

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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

Benzalkonium chloride is typically used as a preservative in liquid formulations, e.g. for topical, ophthalmic, nasal and parenteral applications. It is effective against a wide range of bacteria, yeast and fungi.
Due to a defined C12:C14 ratio with high batch-to-batch consistency, Benzalkonium chloride Emprove® Expert provides higher solubility and antimicrobial activity. It can be used in combination with thimerosal, disodium edetate and benzyl alcohol to further increase antimicrobial activity.
This product is also available as 50% aqueous solution (Art.No. 137124).

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 Statements

Hazard Classifications

Acute Tox. 4 Oral - Aquatic Acute 1 - Aquatic Chronic 1 - Eye Dam. 1 - Skin Corr. 1B

Storage Class Code

8A - Combustible corrosive hazardous materials

WGK

WGK 2


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.

PRTR

Class I Designated Chemical Substances

JAN Code

1371231000:
1371230100:
137123-RSAMPLE:
CO1E1371231000:
137123-BULK:


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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