| Benzalkonium Chloride Solution USP-NF/Ph.Eur PARENTEX 500ML | |||
| P0260LM500 | 45978G115DY | ||
| USP-NF/Ph.Eur PARENTEX | 45978G1 | ||
| 8001-54-5 | 113707 | ||
| --- | April 2025 | ||
| March 2028 | |||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Apperance/Description | Clear colourless liquid. | Clear, colourless or slightly yellowish liquid. | USP-NF/ Ph.Eur |
| 2 | Solubility | Complies | Miscible with water and with ethanol (96%). It froths copiously when shaken | Ph.Eur |
| 3 | Identification (By chemical test 1) | Complies | A white precipitate should form, and it should dissolve after adding 5ml of alcohol | USP-NF |
| 4 | Identification (By chemical test 2) | Complies | An orange-red color should produce. | USP-NF |
| 5 | Identification (By chemical test 3) | Complies | The crystals should melt at 127°C to 133°C | Ph.Eur |
| 6 | Identification (By chemical test 4) | Complies | The methylene chloride layer should become blue. | Ph.Eur |
| 7 | Identification (Chloride) | Complies | A solution should yield a white, curdy precipitate which should insoluble in nitric acid but soluble in slight excess of 6 N ammonium hydroxide | USP-NF/ Ph.Eur |
| 8 | Identification (By UV spectrophotometry) | Complies | Absorbance maxima should be at 257 nm, 263 nm and 269 nm. Shoulder about 250 nm | Ph.Eur |
| 9 | Identification (By Liquid Chromatography) | Complies | The 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 | USP-NF/ Ph.Eur |
| 10 | Appearance of solution | Complies | Solution should be clear and not more intensely coloured than reference solution Y6 | Ph.Eur |
| 11 | Acidity or Alkalinity | 0.08ml of 0.1M hydrochloric acid required | Not more than 0.1ml of 0.1M hydrochloric acid or 0.1M sodium hydroxide should require to change the colour of the indicator | USP-NF/ Ph.Eur |
| 12 | Average relative molecular mass and ratio of Alkyl components (C12 homologue) | 61.65% | NLT 40.0% (on solid basis) | USP-NF/ Ph.Eur |
| 13 | Average relative molecular mass and ratio of Alkyl components (C14 homologue) | 38.35% | NLT 20.0% (on solid basis) | USP-NF/ Ph.Eur |
| 14 | Average relative molecular mass and ratio of Alkyl components (Sum of C12 and C14 homologue) | 100.0% | NLT 70.0% (on solid basis) | USP-NF/ Ph.Eur |
| 15 | Impurities A (Benzyl alcohol) | 0.02% | NMT 0.5% | USP-NF/ Ph.Eur |
| 16 | Impurities B (Benzaldehyde) | 0.04% | NMT 0.15% | USP-NF/ Ph.Eur |
| 17 | Impurities C (chloromethyl)benzene | Not detected | NMT 0.05% | USP-NF/ Ph.Eur |
| 18 | Amine & amine salts | Complies | The 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. | USP-NF/ Ph.Eur |
| 19 | Sulphated ash | 0.07% | NMT 0.1% | Ph.Eur |
| 20 | Assay (Total Alkylbenzyldimethylammonium chlorides) | 509 g/L (50.9%) | 475g/L to 525 g/L (47.5%w/v to 52.5% w/v) | USP-NF/ Ph.Eur |
| 21 | Other components Alcohol content (If added) | Not added | NMT 10.0% v/v | USP-NF/ Ph.Eur |
| 22 | Total aerobic microbial count | Less than 1000 CFU/mL | NMT 1000 CFU/mL | In-house |
| 23 | Total Yeast and mold count | Less than 100 CFU/mL | NMT 100 CFU/mL | In-house |
| 24 | Bacterial endotoxin test | Less than 0.5 EU/mg | NMT 0.5 EU/mg | In-house |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, Ph.Eur SPECIFICATION.
Actylis 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.
