Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate, Thane(W)-400604, MH, India
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Kanamycin sulphate
SKU:
TC136M
CAS Number :
25389-94-0
Molecular Formula :
C₁₈H₃₆N₄O₁₁.H₂SO₄
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Product Identifier
| Product Code | TC136M |
|---|---|
| Molecular weight | 582.58 |
| Molecular formula | C18H36N4O11.H2SO4 |
| CAS No. | 25389-94-0 |
Technical Specification
| Appearance (USP, JP) | White crystalline powder |
|---|---|
| Solubility (USP) | Freely soluble in water; insoluble in acetone, in ethyl acetate and in benzene |
| Solubility (JP) | It is freely soluble in water and practically insoluble in ethanol (99.5%) |
| Identification A : FTIR (USP) | Matches with the standard pattern |
| Identification 1 (JP) | A blue-purple colour develops |
| Identification B : Sulfate (USP) | Meets the requirements |
| Identification 2 (JP) | The principal spot obtained from the sample solution and the spot obtained from the standard solution show a purple-brown colour and the same Rf value |
| Identification C (USP) | The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay |
| Identification 3 (JP) | A white precipitate is formed |
| pH (1% in water at 25°C) (USP) | 6.50 - 8.50 |
| Optical rotation (JP) | +112.00° to +123.00° (1% in water at 20°C) |
| Organic impurity (USP) | The chromatograms show principal spots at the same Rf value and no secondary spot, if present from the sample solution, is more intense than the principal spot of standard solution 2 |
| Related substance : TLC (JP) | The spot other than the principal spot obtained from the sample solution is not more intense than the spot from the standard solution |
| Crystallinity (USP) | Meets the requirements |
| Sulphuric acid : sulphate (JP) | 15.0 - 17.0% (on dried basis) |
| Residue on ignition (USP) | <= 1.00% |
| Residue on ignition (JP) | <= 0.50% |
| Arsenic (JP) | <= 0.0001% |
| Heavy metals (JP) | <= 0.0010% |
| Loss on drying (USP, JP) | <= 4.00% (at 60°C at apressure not exceesing 5 mm of mercuryfor 3 hr) |
| Potency : System suitability : Resolution (USP) | >= 3.00 |
| Potency : System suitability : Relative standard deviation (USP) | <= 2.00% |
| Potency (USP) | min. 750 µg/mg (on dried basis) |
| Potency (JP) | 750 - 832 µg/mg (on dried basis) |
| Bacterial endotoxins (USP) | <= 0.67 USP EU/mg of kanamycin |
| Sterility (USP) | Complies |
Storage and Shelf Life
| Storage | Store at 2 - 8°C away from bright light. |
|---|---|
| Shelf life | 36 months. |
| Use before expiry date | Use before expiry date given on the product label. |
CAS Number :
25389-94-0
Molecular Formula :
C₁₈H₃₆N₄O₁₁.H₂SO₄
| Product Name | Kanamycin sulphate |
|---|---|
| SKU | TC136M |
| CAS No | 25389-94-0 |
| EC No. | 246-933-9 |
| Molecular formula | C₁₈H₃₆N₄O₁₁.H₂SO₄ |
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