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Benzalkonium Chloride Solution USP-NF 1LT
90260LC100166660818AP
USP-NF1666608
26266
---January 2016
December 2018
Sr.No.TestResultSpecification
1DescriptionClear liquid, colourless unless a colour has been added. Has an aromatic odor and a bitter taste.Clear liquid; colorless or slight yellow unless a color has been added. Has an aromatic odor and a bitter taste.
2Identification A (By Chemical test)CompliesA white precipitate is formed, and it is dissolved after adding 5ml of alcohol.
3Identification B (By Chemical test)CompliesA solution of it in a mixture of equal volumes of water and alcohol responds to the tests for chloride.
4Identification C (By Chemical test)CompliesAn orange-red color is produced.
5Identification D (By Liquid Chromatography)CompliesThe retention times of the major peaks for benzalkonium chloride in the sample solution correspond to those of the standard solution, as obtained in the test for ratio of Alkyl components.
6Ratio of Alkyl components (n-C12H25 homolog)NLT 40.0%Not less than 40.0% (Anhydrous basis)
7Ratio of Alkyl components (n-C14H29 homolog)NLT 20.0%Not less than 20.0% (Anhydrous basis)
8Ratio of Alkyl components (The amount of the n-C12H25 and n-C14H29 homolog components together)NLT 70.0%Not less than 70.0% (Anhydrous basis)
9Assay (Total Alkylbenzyldimetylammonium chlorides)49.6%Not less than 47.5% w/v and Not more than 52.5% w/v
10Other components Alcohol content (If added)Not detectedNot more than 10.0% v/v
11Organic impurities (Limit of Amines and Amine salts)CompliesThe volumne 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.
12Organic impurities (Limit of Benzyl alcohol, Benzaldehyde and (chloromethyl) Benzene) : Benzyl alcoholNMT 0.5%Not more than 0.5%
13Organic impurities (Limit of Benzyl alcohol, Benzaldehyde and (chloromethyl) Benzene) :BenzaldehydeNMT 0.15%Not more than 0.15%
14Organic impurities (Limit of Benzyl alcohol, Benzaldehyde and (chloromethyl) Benzene) :(Chloromethyl) BenzeneNMT 0.05%Not more than 0.05%
15Acidity or AlkalinityPassesNot more than 0.1ml of 0.1M hydrochloric acid or 0.1M sodium hydroxide is required.
Remarks: THE CAPTIONED MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF USP-NF SPECIFICATION.
FINAR provides this analytical report in good faith and to the best of its knowledge. It should not be substituted for the users own raw material quality control.
Tested By
(Chemist - Quality Control)
Approved By
(Head - Quality Control)
Computer Generated Report - Does not require Signature.
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