Benzalkonium Chloride Solution USP-NF/Ph.Eur PARENTEX 500ML Go Back

CASR

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Molecular Formula

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Molecular Weight

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Specifications  
Apperance/Description: Clear, colourless or slightly yellowish liquid.
Solubility: Miscible with water and with ethanol (96%). It froths copiously when shaken
Identification (By chemical test 1): A white precipitate should form, and it should dissolve after adding 5ml of alcohol
Identification (By chemical test 2): An orange-red color should produce.
Identification (By chemical test 3): The crystals should melt at 127°C to 133°C
Identification (By chemical test 4): The methylene chloride layer should become blue.
Identification (Chloride): A solution should yield a white, curdy precipitate which should insoluble in nitric acid but soluble in slight excess of 6 N ammonium hydroxide
Identification (By UV spectrophotometry): Absorbance maxima should be at 257 nm, 263 nm and 269 nm. Shoulder about 250 nm
Identification (By Liquid Chromatography): The principal peaks in the chromatogram obtained with the test solution should be similar in retention time to the principal peaks in the chromatogram obtained with the reference solution
Appearance of solution: Solution should be clear and not more intensely coloured than reference solution Y6
Acidity or Alkalinity: Not more than 0.1ml of 0.1M hydrochloric acid or 0.1M sodium hydroxide should require to change the colour of the indicator
Average relative molecular mass and ratio of Alkyl components (C12 homologue): NLT 40.0% (on solid basis)
Average relative molecular mass and ratio of Alkyl components (C14 homologue): NLT 20.0% (on solid basis)
Average relative molecular mass and ratio of Alkyl components (Sum of C12 and C14 homologue): NLT 70.0% (on solid basis)
Impurities A (Benzyl alcohol): NMT 0.5%
Impurities B (Benzaldehyde): NMT 0.15%
Impurities C (chloromethyl)benzene: NMT 0.05%
Amine & amine salts: The volume of titrant added between the two points of inflection should not more than 5.0 ml of 0.1 M tetra butyl ammonium hydroxide solution.
Sulphated ash: NMT 0.1%
Assay (Total Alkylbenzyldimethylammonium chlorides): 475g/L to 525 g/L (47.5%w/v to 52.5% w/v)
Other components Alcohol content (If added): NMT 10.0% v/v
Total aerobic microbial count: NMT 1000 CFU/mL
Total Yeast and mold count: NMT 100 CFU/mL
Bacterial endotoxin test: NMT 0.5 EU/mg
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