CASR |
: | ------ |
Molecular Formula |
: | ------ |
Molecular Weight |
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| Specifications | |
|---|---|
| Description: | White to Light cream-colored, crystalline powder. Is affected by light. |
| Solubility: | Freely soluble in water; soluble in alcohol; sparingly soluble or soluble in ethanol (96%), practically insoluble in ether & methylene chloride |
| Identification (By IR): | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard |
| Identification (By chemical test): | A pale yellow precipitate should be form |
| Identification (by Assay): | The retention time of the major peak of the sample solution should correspond to that of the standard solution as obtain in the assay |
| Identification(By Melting point): | 103°C - 115°C |
| Identification (Mercury): | The spot should disappear |
| Identification (Sulfate): | A white precipitate should form |
| Identification (Sodium): | A dense white precipitate should form. |
| Appearance of solution: | Solution should not be more opalescent than reference suspension II and not more intensely coloured than reference solution B6 |
| pH: | 6.0 - 8.0 |
| Assay (By HPLC, on dried basis): | 97.0% - 102.0% |
| Assay(By titration, dried substance): | 97.0% - 101.0% |
| Mercury/ Inorganic mercury compounds: | NMT 0.70% |
| Organic impurities : Thiosalicylic acid: | NMT 0.10% |
| Organic impurities : Thimerosal related compound A: | NMT 0.10% |
| Organic impurities : Any other individual impurity (Unspecified impurity): | NMT 0.10% |
| Organic impurities : Total impurities: | NMT 1.0% |
| Loss on drying: | NMT 0.5 % |
| Total aerobic microbial count: | NMT 100 CFU/gm |
| Total Yeast and mold count: | NMT 100 CFU/gm |
