| Benzalkonium Chloride Solution Ph.Eur 1LT | |||
| 98260LC100 | 422260901KW | ||
| Ph.Eur. | 4222609 | ||
| 8001-54-5 | 99760 | ||
| --- | November 2023 | ||
| October 2026 | |||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance | Slightly yellowish liquid. | Clear, colourless or slightly yellowish liquid. |
| 2 | Solubility | Complies | Miscible with water and with ethanol (96%). It froths copiously when shaken. |
| 3 | Identification A (By UV spectrophotometry) | Complies | Absorbance maxima should be at 257 nm, 263 nm and 269 nm. Shoulder about 250 nm |
| 4 | Identification B (By Liquid Chromatography) | Complies | 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. |
| 5 | Identification C (By Chemical test) | 130°C | The crystals should melt at 127°C to 133°C |
| 6 | Identification D (By Chemical test) | Complies | The methylene chloride layer should becomes blue. |
| 7 | Identification E (By Chemical test) | Complies | The precipitate should dissolves easily with the possible exception of a few large particles which dissolve slowly. |
| 8 | Appearance of Solution | Complies | Solution should be clear and not more intensely coloured than reference solution Y6. |
| 9 | Acidity or Alkalinity | Complies | Not more than 0.1mL of 0.1M hydrochloric acid or 0.1M sodium hydroxide should require to change the colour of the indicator. |
| 10 | Average relative molecular mass and ratio of Alkyl components (C12 homologue) | 61.64% | NLT 40.0% |
| 11 | Average relative molecular mass and ratio of Alkyl components (C14 homologue) | 38.36% | NLT 20.0% |
| 12 | Average relative molecular mass and ratio of Alkyl components (Sum of C12 and C14 homologue) | 100.00% | NLT 70.0% |
| 13 | Impurities A (Benzyl alcohol) | 0.03% | NMT 0.5% |
| 14 | Impurities B (Benzaldehyde) | 0.02% | NMT 0.15% |
| 15 | Impurities C (chloromethyl)benzene | Not detected | NMT 0.05% |
| 16 | Amine & amine salts | Complies | NMT 5.0 mL of 0.1M tetrabutylammonium hydroxide solution required between two points of inflexion. |
| 17 | Sulphated ash | 0.03% | NMT 0.1% |
| 18 | Assay | 506 g/L | 475g/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.
