8.17046
Benzalkonium chloride
(50% aqueous solution) EMPROVE® ESSENTIAL Ph Eur,NF
Pharma Manufacturing
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Synonym(s):
Alkylbenzyldimethylammonium chloride (50% aqueous solution)
UNSPSC Code:
12352401
Recommended Products
Agency
NF
Ph. Eur.
Quality Level
product line
EMPROVE® ESSENTIAL
form
liquid
density
0.98 g/cm3
storage temp.
15-25°C
Related Categories
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
Precautionary Statements
Hazard Classifications
Acute Tox. 4 Oral - Aquatic Acute 1 - Aquatic Chronic 2 - Eye Dam. 1 - Skin Corr. 1B
WGK
WGK 2
Certificates of Analysis (COA)
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