| Benzalkonium Chloride Solution USP-NF 1LT | |||
| 90260LC100 | 166660818AP | ||
| USP-NF | 1666608 | ||
| 26266 | |||
| --- | January 2016 | ||
| December 2018 | |||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Clear 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. |
| 2 | Identification A (By Chemical test) | Complies | A white precipitate is formed, and it is dissolved after adding 5ml of alcohol. |
| 3 | Identification B (By Chemical test) | Complies | A solution of it in a mixture of equal volumes of water and alcohol responds to the tests for chloride. |
| 4 | Identification C (By Chemical test) | Complies | An orange-red color is produced. |
| 5 | Identification D (By Liquid Chromatography) | Complies | The 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. |
| 6 | Ratio of Alkyl components (n-C12H25 homolog) | NLT 40.0% | Not less than 40.0% (Anhydrous basis) |
| 7 | Ratio of Alkyl components (n-C14H29 homolog) | NLT 20.0% | Not less than 20.0% (Anhydrous basis) |
| 8 | Ratio 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) |
| 9 | Assay (Total Alkylbenzyldimetylammonium chlorides) | 49.6% | Not less than 47.5% w/v and Not more than 52.5% w/v |
| 10 | Other components Alcohol content (If added) | Not detected | Not more than 10.0% v/v |
| 11 | Organic impurities (Limit of Amines and Amine salts) | Complies | The 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. |
| 12 | Organic impurities (Limit of Benzyl alcohol, Benzaldehyde and (chloromethyl) Benzene) : Benzyl alcohol | NMT 0.5% | Not more than 0.5% |
| 13 | Organic impurities (Limit of Benzyl alcohol, Benzaldehyde and (chloromethyl) Benzene) :Benzaldehyde | NMT 0.15% | Not more than 0.15% |
| 14 | Organic impurities (Limit of Benzyl alcohol, Benzaldehyde and (chloromethyl) Benzene) :(Chloromethyl) Benzene | NMT 0.05% | Not more than 0.05% |
| 15 | Acidity or Alkalinity | Passes | Not 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.
