| Benzethonium chloride CPH4 500GM | |||
| 14281SG500 | 258384901FR | ||
| Customised pharma grade 4 | 2583849 | ||
| 121-54-0 | 45983 | ||
| C27H42NO2Cl | June 2018 | ||
| 448.1 | May 2021 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | White powder | White crystals, having a mild odor. Its solution (1 in 100) is slightly alkaline to litmus or White or yellowish white powder. |
| 2 | Solubility | Passes | Soluble in water, in alcohol and in chloroform; slightly soluble in ether. |
| 3 | Identification A (By Chemical test) | Complies | A white precipitate, which is insoluble in 2N nitric acid but soluble in 6N ammonium hydroxide, is formed. |
| 4 | Identification B (By IR) | Complies | To comply the test |
| 5 | Identification C | Complies | The retention time of the major peak of the sample solution corrosponds to the standard solution, as obtained in the Assay. |
| 6 | Assay (on dried basis) | 99.07% | 97.0% - 103.0% |
| 7 | Residue on ignition | 0.008% | 0.1% max |
| 8 | Melting range | 158°C - 163°C | 158°C - 163°C |
| 9 | Loss on drying | 4.08% | 5% max at 105°C for 4 Hr. |
| 10 | Identification A (By Melting point) | 158°C- 164°C | 158°C - 164°C, after drying at 105°C for 4 Hr. |
| 11 | Identification B (By TLC test) | Complies | To comply the test |
| 12 | Identification C (By Chemical test) | Complies | A blue colour develops in the lower layer. |
| 13 | Identification D (By Chemical test) | Complies | The solution gives reaction of chloride. |
| 14 | Appearance of solution | Passes | Solution S is Clear and not more intensely coloured than refrence solution Y6. |
| 15 | Acidity or Alkalinity | Passes | In 2.5gm, NMT 0.3ml of 0.01M sodium hydroxide OR 0.5 ml of 0.01M hydrochloric acid is required to colour change |
| 16 | Volatile bases and salts of volatile bases | NMT 50ppm | 50ppm max |
| 17 | Sulphated ash | 0.008% | 0.1% max |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, 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.
