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8.17046

SAFC

Benzalkonium chloride

(50% aqueous solution) EMPROVE® ESSENTIAL Ph Eur,NF

Pharma Manufacturing

Synonym(s):

Alkylbenzyldimethylammonium chloride (50% aqueous solution)

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About This Item

UNSPSC Code:
12352401

Agency

NF
Ph. Eur.

Quality Level

product line

EMPROVE® ESSENTIAL

form

liquid

density

0.98 g/cm3

storage temp.

15-25°C

General description

(50% aqueous solution) EMPROVE® ESSENTIAL Ph Eur,NF

Analysis Note

Assay (EP)47.5 - 52.5 %Assay (NF)95.0 - 105.0 %Identitypasses testAppearance of solutionpasses testAg (Silver)≤ 1 ppmPd (Palladium)*≤ 1 ppmSb (Antimony)≤ 9 ppmAcidic or alkaline impuritiespasses testAmines, amine saltspasses testC12 homologue (EP)≥ 40 %C14 homologue (EP)≥ 20 %Sum of C12 and C14 homologues (EP)≥ 70 %Impurity A≤ 0.5 %Impurity B≤ 0.15 %Impurity C≤ 0.05 %n-C12H25 homologne (NF)≥ 40.0 %n-C14H29 homologne (NF)≥ 20.0 %Sum of n-C12H25 and n-C14H29 homolognes (NF)≥ 70.0 %Benzyl alcohol≤ 0.5 %Benzaldehyde≤ 0.15 %(Chloromethyl)benzene≤ 0.05 %Residual solvents (ICH Q3C)excluded by the production processSulfated ash≤ 0.1 %Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).Corresponds to Ph Eur, NF

Legal Information

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

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


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