Sumatriptan Succinate is the succinate salt form of Sumatriptan and belongs to the triptan class of pharmaceutical active ingredients. It is a selective serotonin 5-HT₁ receptor agonist used in pharmaceutical formulations for the acute treatment of migraine.
Sumatriptan Succinate has CAS Number 103628-48-4, molecular formula C₁₈H₂₇N₃O₆S and molecular weight 413.49 g/mol. The compound consists of Sumatriptan combined with one equivalent of succinic acid.
Sumatriptan Succinate is chemically associated with the indole-based sulfonamide structure of Sumatriptan and the succinate counterion. The API is generally supplied as a white to off-white crystalline material.
The succinate salt provides a pharmaceutical form of Sumatriptan suitable for incorporation into different dosage forms. The API can be characterized using infrared spectroscopy, HPLC and other appropriate pharmaceutical analytical techniques.
Sumatriptan Succinate has a molecular weight of approximately 413.49 g/mol and is freely soluble in water according to commercial API specifications.
Sumatriptan Succinate is primarily used in pharmaceutical products for the acute treatment of migraine with or without aura.
Sumatriptan acts as an agonist at serotonin 5-HT₁ receptors, particularly 5-HT₁B and 5-HT₁D receptor subtypes. Activation of these receptors contributes to cranial vasoconstriction and inhibition of trigeminal neuropeptide release, providing the pharmacological basis for its antimigraine action.
Sumatriptan Succinate is used in pharmaceutical dosage forms including oral formulations, injectable preparations and nasal formulations, depending on the approved product and market.
Sumatriptan Succinate API can be evaluated through identity, assay, related-substance, moisture, inorganic-residue and physical-property testing according to the applicable pharmacopoeial or customer specification.
The USP monograph includes an HPLC assay procedure using UV detection at 282 nm and an L1 chromatographic column.
Typical analytical controls may include:
Commercial pharmaceutical API specifications report assay values of at least 98.0%, with other commercial specifications reporting HPLC purity of at least 99.0% and total impurities not more than 0.5%.
Swapnroop Drugs and Pharmaceuticals provides pharmaceutical API manufacturing capabilities for Sumatriptan Succinate with quality-focused analytical evaluation and documentation.
Sumatriptan Succinate API can be handled according to applicable pharmacopoeial requirements and agreed customer specifications. Quality evaluation can address identity, assay, related substances, moisture, inorganic residue and physical characteristics.
For pharmaceutical companies requiring Sumatriptan Succinate API from an India-based manufacturer, specification alignment, batch consistency, analytical testing and appropriate documentation are important considerations.
Sumatriptan Succinate API should be stored in suitable, tightly closed pharmaceutical packaging that protects the material from contamination, moisture and excessive environmental exposure.
Recommended handling includes:
Depending on customer and regulatory requirements, documentation may include:
Swapnroop Drugs and Pharmaceuticals focuses on pharmaceutical API manufacturing with quality systems, analytical evaluation and documentation intended to support pharmaceutical applications.
Sumatriptan Succinate API is handled according to defined quality requirements with attention to identity, assay, impurities, physical characteristics and batch-to-batch consistency.
Customers can discuss Sumatriptan Succinate API requirements, applicable specifications, packaging and documentation with Swapnroop Drugs and Pharmaceuticals.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.2% |
| Total Impurities | NMT 0.5% |
| Melting Point | 165–170°C |