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Benzalkonium Chloride Solution Ph.Eur 1LT
98260LC100351400902GU
Ph.Eur.3514009
76220
---July 2021
June 2024
Sr.No.TestResultSpecification
1AppearanceClear, slightly yellowish liquid.Clear, colourless or slightly yellowish liquid.
2SolubilityPassesMiscible with water and with ethanol (96%). It froths copiously when shaken.
3Identification A (By UV spectrophotometry)CompliesAbsorbance maxima should be at 257 nm, 263 nm and 269 nm. Shoulder about 250 nm
4Identification B (By Liquid Chromatography)CompliesThe 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.
5Identification C (By Chemical test)CompliesThe crystals should melt at 127°C to 133°C
6Identification D (By Chemical test)CompliesThe methylene chloride layer should becomes blue.
7Identification E (By Chemical test)CompliesThe precipitate should dissolves easily with the possible exception of a few large particles which dissolve slowly.
8Appearance of SolutionPassesSolution should be clear and not more intensely coloured than reference solution Y6.
9Acidity or AlkalinityPassesNot more than 0.1mL of 0.1M hydrochloric acid or 0.1M sodium hydroxide should require to change the colour of the indicator.
10Average relative molecular mass and ratio of Alkyl components (C12 homologue)61.4%Min. 40.0%
11Average relative molecular mass and ratio of Alkyl components (C14 homologue)38.6%Min. 20.0%
12Average relative molecular mass and ratio of Alkyl components (Sum of C12 and C14 homologue)100.0%Min. 70.0%
13Impurities A (Benzyl alcohol)0.05%Not more than 0.5%
14Impurities B (Benzaldehyde)0.03%Not more than 0.15%
15Impurities C (chloromethyl)benzene0.01%Not more than 0.05%
16Amine & amine salts2.1 mL of 0.1M tetrabutylammonium hydroxideNot greater than 5.0 mL of 0.1M tetrabutylammonium hydroxide solution required between two points of inflexion.
17Sulphated ash0.04%0.1% max.
18Assay496 g/L475g/L to 525 g/L
Remarks: THE CAPTIONED MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF PH.EUR 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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