| Thiomersal USP/Ph.Eur 100GM | |||
| 95840SG100 | 364837116LU | ||
| USP/Ph.Eur | 3648371 | ||
| 54-64-8 | 81619 | ||
| C2H5HgSC6H4COONa | December 2021 | ||
| 404.81 | November 2024 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | White to light cream-colored, crystalline powder. Is affected by light. | White to Light cream-colored, crystalline powder. Is affected by light. |
| 2 | Solubility | Passes | Freely soluble in water; soluble in alcohol; sparingly soluble or soluble in ethanol (96%), practically insoluble in ether & methylene chloride |
| 3 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard |
| 4 | Identification (By chemical test) | Complies | A pale yellow precipitate should be form |
| 5 | Identification (by Assay) | Complies | The retention time of the major peak of the sample solution should correspond to that of the standard solution as obtain in the assay |
| 6 | Identification(By Melting point) | 107°C | 103°C - 115°C |
| 7 | Identification (Mercury) | Complies | The spot should disappear |
| 8 | Identification (Sulfate) | Complies | A white precipitate should form |
| 9 | Identification (Sodium) | Complies | A dense white precipitate should form. |
| 10 | Appearance of solution | Passes | Solution should not be more opalescent than reference suspension II and not more intensely coloured than reference solution B6 |
| 11 | pH | 7.09 | 6.0 - 8.0 |
| 12 | Assay (By HPLC, on dried basis) | 99.23% | 97.0% - 102.0% |
| 13 | Assay(By titration, dried substance) | 98.6% | 97.0% - 101.0% |
| 14 | Mercury/ Inorganic mercury compounds | 0.46% | NMT 0.70% |
| 15 | Organic impurities : Thiosalicylic acid | Not detected | NMT 0.10% |
| 16 | Organic impurities : Thimerosal related compound A | 0.07% | NMT 0.10% |
| 17 | Organic impurities : Any other individual impurity (Unspecified impurity) | 0.06% | NMT 0.10% |
| 18 | Organic impurities : Total impurities | 0.13% | NMT 1.0% |
| 19 | Loss on drying | 0.3% | NMT 0.5 % |
Remarks: THE CAPTIONED MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF USP 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.
