General Information Ticagrelor IP/EP/USP
| CAS Number | Molecular Formula | Molecular Weight |
|---|---|---|
| 274693-27-5 | C23H28F2N6O4S | 522.567 g/mol |
Specification and results for Ticagrelor IP
| Sr. No. | Test Parameter | Specification Required | Results |
|---|---|---|---|
| 1 | Description | A White or almost white to pale pink Powder | Almost White powder |
| 2 | Identification | ||
| By IR | The infrared absorption spectrum of the Sample Should be concordant with the spectrum obtained with Ticagrelor reference/working standard or with reference spectrum of Ticagrelor. | The infrared absorption spectrum of the sample is concordant with the spectrum obtained with Ticagrelor working standard. | |
| By HPLC | In the Assay, the principal peak in the chromatogram obtained with the test solution should correspond to the principal peak in the chromatogram obtained with the reference solution. | In the Assay, the principal peak in the chromatogram obtained with the test solution should correspond to the principal peak in the chromatogram obtained with the reference solution. | |
| 3 | Solubility | Freely Soluble in methanol, soluble in ethanol, practically insoluble in water and in heptane. | Freely Soluble in methanol, soluble in ethanol, practically insoluble in water and in heptane. |
| 4 | Related Substances by HPLC | ||
| Ticagrelor Impurity – A | Not More than 0.2 % | Below Disregard Limit. | |
| Ticagrelor Impurity – B | Not More than 0.2 % | Below Disregard Limit. | |
| Ticagrelor Impurity – C | Not More than 0.1 % | Not Detected | |
| Ticagrelor Impurity – D | Not More than 0.3 % | Not Detected | |
| Ticagrelor Impurity – E | Not More than 0.8 % | Not Detected | |
| Any Secondary Impurity | Not More than 0.10 % | Not Detected | |
| Total Impurity | Not More than 1.00 % | Not Detected | |
| 5 | Sulphated Ash | Not More than 0.6% w/w | 0.10% w/w |
| 6 | Water content by KF | Not More than 0.5% w/w | 0.23% w/w |
| 7 | Assay by HPLC (on anhydrous basis) | Not Less than 97.5% w/w and more than 102.0% w/w of Ticagrelor (C23H28F2N6O4S) | 99.63% W/W |
| 8 | Residual Solvent by GC-HS | ||
| Methylene Chloride | Not More than 600ppm | Not Detected | |
| Acetonitrile | Not More than 410ppm | 120 ppm | |
| Methanol | Not More than 3000ppm | 175 ppm | |
| Cyclohexane | Not More than 3880ppm | 1 ppm | |
| Ethyl Acetate | Not More than 5000ppm | 30 ppm | |
Specification and results for Ticagrelor EP
| Sr. No. | Test Parameter | Specification Required | Results |
|---|---|---|---|
| 1 | Description | A White or almost white to pale pink Powder | Almost White powder |
| 2 | Identification | ||
| By IR | The infrared absorption spectrum of the Sample Should be concordant with the spectrum obtained with Ticagrelor reference/working standard or with reference spectrum of Ticagrelor. | The infrared absorption spectrum of the sample is concordant with the spectrum obtained with Ticagrelor working standard. | |
| By HPLC | In the Assay, the principal peak in the chromatogram obtained with the test solution should correspond to the principal peak in the chromatogram obtained with the reference solution. | In the Assay, the principal peak in the chromatogram obtained with the test solution should correspond to the principal peak in the chromatogram obtained with the reference solution. | |
| 3 | Solubility | Freely Soluble in methanol, soluble in ethanol, practically insoluble in water and in heptane. | Freely Soluble in methanol, soluble in ethanol, practically insoluble in water and in heptane. |
| 4 | Related Substances by HPLC | ||
| Ticagrelor Impurity – A | Not More than 0.2 % | Below Disregard Limit. | |
| Ticagrelor Impurity – B | Not More than 0.2 % | Below Disregard Limit. | |
| Ticagrelor Impurity – C | Not More than 0.1 % | Not Detected | |
| Ticagrelor Impurity – D | Not More than 0.3 % | Not Detected | |
| Any Secondary Impurity | Not More than 0.10 % | Not Detected | |
| Ticagrelor Impurity – E | Not More than 0.8 % | Not Detected | |
| Total Impurity | Not More than 1.00 % | Not Detected | |
| 5 | Sulphated Ash | Not More than 0.6% w/w | 0.10% w/w |
| 6 | Water content by KF | Not More than 0.5% w/w | 0.23% w/w |
| 7 | Assay by HPLC (on anhydrous basis) | Not Less than 97.5% w/w and more than 102.0% w/w of Ticagrelor (C23H28F2N6O4S) | 99.63% W/W |
| 8 | Residual Solvent by GC-HS | ||
| Methylene Chloride | Not More than 600ppm | Not Detected | |
| Acetonitrile | Not More than 410ppm | 120 ppm | |
| Methanol | Not More than 3000ppm | 175 ppm | |
| Cyclohexane | Not More than 3880ppm | 1 ppm | |
| Ethyl Acetate | Not More than 5000ppm | 30 ppm | |
Specification and results for Ticagrelor USP
| Sr. No. | Test Parameter | Specification Required | Results |
|---|---|---|---|
| 1 | Description | A White or almost white to pale pink Powder | Almost White powder |
| 2 | Identification | ||
| By IR | The IR spectrum of sample should be correspond to that of Ticagrelor spectrum | Complies | |
| By HPLC | The Retention time of the major peak in the chromatogram of the sample preparation correspond to that of the standard preparation as obtained in the assay method. | Complies | |
| 3 | Solubility | Freely Soluble in methanol, soluble in ethanol, practically insoluble in water and in n-Heptane. | Freely Soluble in methanol, soluble in ethanol, practically insoluble in water and in n-Heptane. |
| 4 | Related Substances by HPLC | ||
| Ticagrelor Impurity – A | Not More than 0.2 % | Below Disregard Limit. | |
| Ticagrelor Impurity – B | Not More than 0.2 % | Below Disregard Limit. | |
| Ticagrelor Impurity – C | Not More than 0.1 % | Not Detected | |
| Ticagrelor Impurity – D | Not More than 0.3 % | Not Detected | |
| Ticagrelor Impurity – E | Not More than 0.8 ppm | Not Detected | |
| Any Secondary Impurity | Not More than 0.10 % | Not Detected | |
| Total Impurity | Not More than 1.00 % | Not Detected | |
| 5 | Sulphated Ash | Not More than 0.1% w/w | 0.05% w/w |
| 6 | Water content by KF | Not More than 0.5% w/w | 0.16% w/w |
| 7 | Assay by HPLC (on anhydrous basis) | Not Less than 98% w/w and more than 102.0% w/w of Ticagrelor (C23H28F2N6O4S) | 99.63% W/W |
| 8 | p-XRD | The X-Ray powder diffractogram of sample should be exhibit intense 2θ values at 5.5,6.5,10.6,13.5,14.9,18.3,19.2,22.7,24.3, and 27.1°(±0.2°) | Complies |
| 9 | Heavy metals | Not More than 10ppm | Less than 10ppm |
| 10 | Acetic acid content by HPLC | Not More than 5000ppm | Not Detected |
| 11 | Residual Solvent by GC-HS | ||
| Methanol | Not More than 3000ppm | Not Detected | |
| Isopropyl alcohol | Not More than 5000ppm | Not Detected | |
| Dichloromethane | Not More than 600ppm | Not Detected | |
| Cyclohexane | Not More than 3880ppm | Not Detected | |
| Ethyl Acetate | Not More than 5000ppm | Not Detected | |
| n-Heptane | Not More than 5000ppm | 13ppm | |
| Toluene | Not More than 890ppm | Not Detected | |
| Diisopropyl ethylamine | Not More than 100ppm | Not Detected | |
| 12 | Particle size(μm) 13.1 D90 | Not More than 25ppm | 10.30ppm |