Specification of Analysis
| Appearance | White or off-white solid powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies |
| Solubility | Soluble in DMF, sparingly soluble in THF, slightly soluble in m'ethanol and a'cetonitrile, very sightly soluble in ethanol and d'ichloromethane, insoluble in water | Complies |
| Polymorphic Form | Polymorphic form 1 | Complies |
| Melting Point | 211ºC~216ºC | 212.8ºC~214.9ºC |
| Water Content | ≤ 0.50% | 0.10% |
| Heavy Metals | ≤ 20ppm | Complies |
| Residue on Ignition | ≤ 0.20% | 0.09% |
| Related Substance | Any single impurity: ≤0.10% | 0.06% |
| Total Impurities: ≤1.00% | 0.16% |
| Assay (on the anhydrous basis) | 98.0%~102.0% | 99.94% |
| Particle Size | D90: ≤100µm | Complies |
| Reference Standard | In-house Standard |
| Conclusion | The product complied to In-house standard. |
| Storage | Preserve in tight,light-resistant containers in a cool |
Description:
Azathioprine is used alone or in combination with other immunosuppressive therapy to prevent rejection following organ transplantation, and to treat an array of autoimmune diseases, including rheumatoid arthritis, pemphigus, systemic lupus erythematosus, Behçet's disease, and other forms of vasculitis, autoimmune hepatitis, atopic dermatitis, myasthenia gravis, neuromyelitis optica (Devic's disease), restrictive lung disease, and others. It is also an important therapy and steroid-sparing agent for inflammatory bowel disease (such as Crohn's disease and ulcerative colitis) and for multiple sclerosis.
Function and Application
Azathioprine is used to prevent rejections of kidney or liver allografts, usually in conjunction with other therapies including corticosteroids, other immunosuppressants, and local radiation therapy. The administration protocol starts either at the time of transplantation or within the following two days.
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