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Benzalkonium Chloride Solution USP-NF/Ph.Eur PARENTEX 2.5LT
P0260LC25035934G105JU
USP-NF/Ph.Eur PARENTEX35934G1
79443
---October 2021
September 2024
Sr.No.TestResultSpecification
1Apperance/DescriptionClear, slightly yellowish liquid.Clear, colourless or slightly yellowish liquid.
2SolubilityPassesMiscible with water and with ethanol (96%). It froths copiously when shaken
3Identification (By chemical test 1)CompliesA white precipitate should form, and it should dissolve after adding 5ml of alcohol
4Identification (By chemical test 2)CompliesAn orange-red color should produce.
5Identification (By chemical test 3)130°CThe crystals should melt at 127°C to 133°C
6Identification (By chemical test 4)CompliesThe methylene chloride layer should become blue.
7Identification (Chloride)CompliesA solution should yield a white, curdy precipitate which should insoluble in nitric acid but soluble in slight excess of 6 N ammonium hydroxide
8Identification (By UV spectrophotometry)CompliesAbsorbance maxima should be at 257 nm, 263 nm and 269 nm. Shoulder about 250 nm
9Identification (By Liquid Chromatography)CompliesThe 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
10Appearance of solutionPassesSolution should be clear and not more intensely coloured than reference solution Y6
11Acidity 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
12Average relative molecular mass and ratio of Alkyl components (C12 homologue)61.58%NLT 40.0% (on solid basis)
13Average relative molecular mass and ratio of Alkyl components (C14 homologue)38.35%NLT 20.0% (on solid basis)
14Average relative molecular mass and ratio of Alkyl components (Sum of C12 and C14 homologue)99.92%NLT 70.0% (on solid basis)
15Impurities A (Benzyl alcohol)0.05%NMT 0.5%
16Impurities B (Benzaldehyde)0.03%NMT 0.15%
17Impurities C (chloromethyl)benzene0.03%NMT 0.05%
18Amine & amine salts2.3 ml of 0.1 M tetra butyl ammonium hydroxideThe 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.
19Sulphated ash0.05%NMT 0.1%
20Assay (Total Alkylbenzyldimethylammonium chlorides)500g/L (50.0%)475g/L to 525 g/L (47.5%w/v to 52.5% w/v)
21Other components Alcohol content (If added)Not applicableNMT 10.0% v/v
22Total aerobic microbial countLess than 1000 CFU/mLNMT 1000 CFU/mL
23Total Yeast and mold countLess than 100 CFU/mLNMT 100 CFU/mL
24Bacterial endotoxin testLess than 0.5 EU/mgNMT 0.5 EU/mg
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF AND 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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