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12063 Sigma-Aldrich

Benzalkonium chloride

PharmaGrade, EP, USP, JP, manufactured under appropriate GMP controls for pharma or biopharmaceutical production

Synonym: Alkylbenzyldimethylammonium chloride, Alkyldimethylbenzylammonium chloride, Benzalkonii chloridum

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Properties

Related Categories Biochemicals and Reagents, Cationic Detergents, Detergents, Detergents A to M, Preservatives and Antimicrobials for Protein Stabilization,
Quality Level   GMP
grade   EP
  JP
  USP
description   cationic
product line   PharmaGrade
assay   95.0-105.0% (JP; calc. on dry substance)
  97.0-103.0% (Ph. Eur and NF; calc. on dry substance)
impurities   amine and amine salts, complies
  ≤0.05% benzyl chloride
  ≤0.1% sulfated ash
  ≤0.15% benzaldehyde
  ≤0.5% benzyl alcohol
  ≤10% water
suitability   complies for acidity or alkalinity

Description

Analysis Note

ratio of alkyl components
• C12 Homologue ≥40.0 % w/w
• C14 Homologue ≥20.0 % w/w
• C12 + C14 Homologue ≥70.0 % w/w

identity
• JP identity 1 : corresponds to requirements
• JP identity 2 : corresponds to requirements
• JP identity 3 : corresponds to requirements
• JP identity 4 : corresponds to requirements

identification
• USP identification A and C, EP identification E : corresponds to requirements
• USP identification B : corresponds to requirements
• EP identification B and USP identification D (HPLC) :corresponds to requirements

purity
• purity 1 (JP) and water-insoluble matter (USP) : colorless to light yellow solution (≤3.5 NTU) free from unsoluble matter
• purity 2 (JP) petroleum ether soluble substances : ≤1.0 %

appearance of solution
• clear solution (≤3.5 NTU) not more intensely colored than reference solution Y6

average reactive molecular mass
• determine

General description

PharmaGrade products are manufactured under appropriate controls for use as a raw material in pharma or biopharmaceutical production. For more information on the PharmaGrade Program, visit sigma-aldrich.com/safc-pharmagrade.

Linkage

Enhanced Quality Product Documentation on PharmaGrade Benzalkonium Chloride

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Laboratory Gloves
Safety & Documentation

Safety Information

Symbol 
Signal word 
Danger
Hazard statements 
Precautionary statements 
RIDADR 
UN3261 - class 8 - PG 2 - EHS - Corrosive solid, acidic, organic, n.o.s., HI: all
WGK Germany 
2
Protocols & Articles

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