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Sumatriptan is a medication used for the treatment of migraine and cluster headaches.
It is a synthetic drug belonging to the triptan class. Structurally, it is an analog of the naturally occurring neuro-active alkaloids dimethyltryptamine (DMT), bufotenine, and 5-methoxy-dimethyltryptamine, with an N-methyl sulfonamidomethyl- group at position C-5 on the indole ring.
Specification:
|
Item |
Specifications |
|
Character |
Appearance: White or almost white powder. |
|
Solubility: Freely soluble in water, sparingly soluble in methanol, practically insoluble in methylene chloride. |
|
|
Identification |
Infrared absorption spectrophotometry: corresponds to Sumatriptan succinate CRS. |
|
PH |
4.5~5.3 |
|
Absorbance: |
Maximum 0.10 |
|
Related substances |
Impurity A: not more than 0.6 percent |
|
Impurity H: not more than 0.3 percent |
|
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Impurity B,C or D: each impurity not more than 0.5 percent |
|
|
Impurity E or any other impurity: each impurities not more than 0.1 percent |
|
|
Total impurities: not more than 0.6 percent |
|
|
Water |
not more than 1.0 percent |
|
Sulphated ash |
not more than 0.1 percent |
|
Residual solvents |
Methanol:not more than 3000ppm |
|
Acetonitrite:not more than 100ppm |
|
|
Isopropyl Alcohol:not more than 100ppm |
|
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Chloroform:not more than 60ppm |
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|
Assay |
97.5 percent to102.0 percent (Anhydrous substance). |
Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
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Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
