SUMATRIPTAN SUCCINATE

Sumatriptan Succinate is a potent selective serotonin (5-HT₁) receptor agonist used for the acute treatment of migraine and cluster headaches. It works by narrowing dilated cranial blood vessels and inhibiting inflammatory neuropeptide release, thereby providing rapid relief from headache, nausea, and light sensitivity.

At Bluepill Express, we manufacture and export high-purity Sumatriptan Succinate API that meets stringent international quality standards (IP/BP/USP/EP). Produced under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, our API offers excellent chemical stability, high assay values (≥99%), and low impurity levels, ensuring reliable performance in finished dosage formulations.

Sumatriptan Succinate is widely formulated into oral tablets, nasal sprays, and injectable solutions used in global markets. It delivers fast-acting migraine control with proven efficacy and tolerability.

Therapeutic Applications:

• Acute treatment of migraine attacks with or without aura
• Management of cluster headaches
• Relief from migraine-related nausea, photophobia, and phonophobia

Mechanism of Action:

Sumatriptan acts as a selective agonist at serotonin (5-HT₁B/1D) receptors, causing constriction of intracranial arteries and inhibition of pro-inflammatory neuropeptides (such as CGRP). This dual mechanism provides quick and sustained migraine relief.

Technical Specifications:

• Chemical Name: 3-[2-(Dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulfonamide butanedioate (1:1)
• Molecular Formula: C₁₄H₂₁N₃O₂S·C₄H₆O₄
• Molecular Weight: 413.5 g/mol
• CAS Number: 103628-46-2
• Appearance: White to off-white crystalline powder
• Assay (on dried basis): NLT 98.0% and NMT 102.0%
• Solubility: Freely soluble in water and methanol; slightly soluble in ethanol
• Storage Conditions: Store below 25°C, protected from light and moisture

Pharmacological Classification:

• Therapeutic Class: Antimigraine agent / Serotonin 5-HT₁ receptor agonist
• Pharmacopoeial Standards: IP / BP / USP / EP
• Dosage Form Applications:
  • Oral tablets (25 mg, 50 mg, 100 mg)
  • Nasal sprays
  • Subcutaneous injections

Manufacturing & Quality Standards – Bluepill Express:

• Produced under WHO-GMP, ISO 9001:2015, and cGMP-compliant facilities
• High assay (≥99%) with tight control on impurity profile
• Validated analytical methods (HPLC, FTIR, and NMR) ensure consistent quality
• Low residual solvents in compliance with ICH Q3C standards
• Comprehensive documentation available (COA, MSDS, DMF, stability data)
• Batch-to-batch uniformity with validated manufacturing protocols

Advantages of Bluepill Express Sumatriptan Succinate API:

• High purity and excellent crystallinity
• Rapid solubility suitable for oral and injectable dosage forms
• DMF-ready API for regulated markets
• Consistent particle size for enhanced formulation performance
• Backed by strong regulatory and documentation support

Packaging & Export Details:

• Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with double LDPE liners
• Shelf Life: 3 years when stored under recommended conditions
• Labeling: As per pharmacopeial and international regulatory guidelines
• Export Markets: Europe, Africa, Latin America, Middle East, and Asia-Pacific
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Drug Master File (DMF – available upon request)
  • Stability and validation reports