Benzalkonium Chloride Solution Powder Specifications of Commercial Pure & BP Ph Eur USP Grade Manufacturers & Exporters
Please visit Benzalkonium Chloride Solution Powder USP NF ACS BP Ph Eur EP JP IP Analytical reagent FCC Food grade Manufacturers our associates world class FDA-GMP approved, ISO-9001 Certified facility Anmol Chemicals
Benzalkonium Chloride Solution Powder CAS Number 8001-54-5 or 63449-41-2
Specifications of Benzalkonium Chloride BP Ph Eur Grade:
CAS 8001-54-5
Action and use: Antiseptic.
DEFINITION
Mixture of alkylbenzyldimethylammonium chlorides, the alkyl groups mainly having chain lengths of C12, C14and C16.
Content: 95.0 per cent to 104.0 per cent of alkylbenzyldimethylammonium chlorides (anhydrous substance) calculated using the average relative molecular mass.
CHARACTERS
Appearance: White or yellowish-white powder or gelatinous, yellowish-white fragments, hygroscopic. On heating it forms a clear molten mass.
Solubility: Very soluble in water and in ethanol (96 per cent). An aqueous solution froths copiously when shaken.
IDENTIFICATION
First identification: B, E
Second identification: A, C, D, E
A. Ultraviolet and visible absorption spectrophotometry - To pass the test.
B. Examine the chromatograms obtained in the test for average relative molecular mass and ratio of alkyl components.
Results The principal peaks in the chromatogram obtained with the test solution are similar in retention time to the principal peaks in the chromatogram obtained with the reference solution.
C. To 2 mL of solution S (see Tests) add 0.1 mL of glacial acetic acid and, drop-wise, 1 mL of sodium tetraphenylborate solution. A white precipitate is formed. Filter. Dissolve the precipitate in a mixture of 1 mL of acetone and 5 mL of ethanol (96 per cent) heating to not more than 70C. Add water drop-wise to the warm solution until a slight opalescence forms. Heat gently until the solution is clear and allow to cool. White crystals separate. Filter, wash with 3 quantities, each of 10 mL, of water and dry in vacuo overdiphosphorus pentoxide or anhydrous silica gel at a temperature not exceeding 50C. The crystals melt at 127C to 133C.
D. To 5 mL of dilute sodium hydroxide solution add 0.1 mL of bromophenol blue solution and 5 mL of methylene chloride and shake. The methylene chloride layer is colourless. Add 0.1 mL of solution S and shake. The methylene chloride layer becomes blue.
E. To 2 mL of solution S add 1 mL of dilute nitric acid. A white precipitate is formed which dissolves on the addition of 5 mL of ethanol (96 per cent). The solution gives reaction of chlorides.
TESTS
Solution S: Dissolve 1.0 g in carbon dioxide-free water and dilute to 100 mL with the same solvent.
Appearance of solution: Solution S is clear and not more intensely coloured than reference solution.
Acidity or alkalinity: To 50 mL of solution S add 0.1 mL of bromocresol purple solution. Not more than 0.1 mL of0.1 hydrochloric acid or 0.1 M sodium hydroxide is required to change the colour of the indicator.
Average relative molecular mass and ratio of alkyl components: To pass the test.
Impurities A, B and C: To pass the test.
Amines and amine salts: To pass the test.
Water: Maximum 10 per cent, determined on 0.300 g.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
Specifications of Benzalkonium Chloride USP Grade:
Ammonium, alkyldimethyl(phenylmethyl)-, chloride.
Alkylbenzyldimethylammonium chloride CAS 8001-54-5.
Benzalkonium Chloride is a mixture of alkylbenzyldimethylammonium chlorides of the general formula: [C6H5CH2N(CH3)2R]Cl in which R represents a mixture of alkyls, including all or some of the group beginning with n-C8H17 and extending through higher homologs, with n-C12H25, n-C14H29, and n-C16H33 comprising the major portion. On the anhydrous basis, the content of the n-C12H25 homolog is not less than 40.0 percent, and the content of the n-C14H29 homolog is not less than 20.0 percent, of the total alkylbenzyldimethylammonium chloride content. The amounts of the n-C12H25 and n-C14H29 homolog components comprise together not less than 70.0 percent of the total alkylbenzyldimethylammonium chloride content. The total alkylbenzyldimethylammonium chloride content, calculated on the anhydrous basis, allowance being made for the amount of residue on ignition, is not less than 97.0 percent and not more than 103.0 percent of [C6H5CH2N(CH3)2R]Cl.
Identification:
A: To a solution (1 in 100) add 2 N nitric acid or mercuric chloride TS: a white precipitate is formed, and it is soluble in alcohol.
B: Dissolve about 200 mg in 1 mL of sulfuric acid, add 100 mg of sodium nitrate, and heat on a steam bath for 5 minutes. Cool, dilute with water to 10 mL, add 500 mg of zinc dust, and warm for 5 minutes on a steam bath. To 2 mL of the clear supernatant add 1 mL of sodium nitrite solution (1 in 20), cool in ice water, then add 3 mL of a solution of 500 mg of 2-naphthol in 10 mL of 6 N ammonium hydroxide: an orange-red color is produced.
C: A solution of it in a mixture of equal volumes of water and alcohol responds to the tests for Chloride.
Water: not more than 15.0%.
Residue on ignition: not more than 2.0%.
Water-insoluble matter: A solution (1 in 10) is free from turbidity and insoluble matter.
Limit of foreign amines: To 5 mL of a solution (1 in 50) add 3 mL of 1 N sodium hydroxide: no precipitate is formed. Heat to boiling: the odor of amines is not perceptible.
Ratio of alkyl components: To pass the test.
Benzalkonium Chloride Solution USP Grade:
Benzalkonium Chloride Solution contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of benzalkonium chloride in concentrations of 1.0 percent or more; and not less than 93.0 percent and not more than 107.0 percent of the labeled amount in concentrations of less than 1.0 percent. It may contain a suitable coloring agent and may contain not more than 10 percent of alcohol.
Caution: Mixing Benzalkonium Chloride Solution with ordinary soaps and with anionic detergents may decrease or destroy the bacteriostatic activity of the Solution.
Identification:
A: It responds to Identification tests A and C under Benzalkonium Chloride.
B: The residue obtained by evaporating, on a steam bath, a volume of Solution equivalent to about 200 mg of benzalkonium chloride responds to Identification test B under Benzalkonium Chloride.
Microbial limits: Solution containing less than 5.0% of benzalkonium chloride meets the requirements of the test for absence of Pseudomonas aeruginosa.
Alcohol content (if present): between 95.0% and 105.0% of the labeled amount of C2H5OH is found.
Limit of foreign amines: A volume of Solution, equivalent to 100 mg of benzalkonium chloride, and adjusted to a concentration of 1 in 50, meets the requirements of the test for Foreign amines under Benzalkonium Chloride.
Ratio of alkyl components: To pass the test.
SDS MSDS of Benzalkonium Chloride Solution Powder BP Ph Eur EP JP USP NF IP ACS Analytical Reagent FCC Food grade Manufacturers |
