Fosphenytoin Sodium
Water-soluble prodrug for emergency seizure management. Engineered for rapid infusion, superior tolerability, and unmatched critical-care performance.
CAS Number
92134-98-0
Formula
C₁₆H₁₃N₂NaO₆P
Mol. Weight
382.25 G/MOL
Grade
USP / EP / IP
Product Overview
Fosphenytoin Sodium is a water-soluble prodrug that is rapidly converted to phenytoin in the body. It is primarily used for emergency treatment of status epilepticus and offers improved tolerability and significantly faster administration rates compared to conventional phenytoin formulations.
Manufactured under stringent WHO-GMP certified conditions, our Fosphenytoin Sodium API meets the highest pharmacopeial standards (USP, EP, IP) with consistent batch quality, complete regulatory documentation, and global supply chain reliability.
API Snapshot
Mechanism of Action
Administration
Administered via IV or IM route. The water-soluble formulation enables rapid absorption and systemic distribution.
Prodrug Conversion
Phosphatases rapidly hydrolyze fosphenytoin to phenytoin, phosphate, and formaldehyde within 8–15 minutes post-infusion.
Anticonvulsant Effect
Phenytoin blocks voltage-sensitive sodium channels in neuronal membranes, stabilizing hyperexcited tissue and halting seizure spread.
Therapeutic Applications
Status Epilepticus
First-line IV therapy for acute repetitive and prolonged seizure episodes in emergency settings.
Neurosurgical Prophylaxis
Prevention and control of seizures occurring during or after neurosurgical procedures.
Critical Care Seizure Control
Rapid-onset emergency seizure management in ICU and critical care environments.
Phenytoin Substitution
Short-term parenteral substitute when oral phenytoin therapy is temporarily unavailable.
Key Advantages Over Conventional Phenytoin
Fosphenytoin Sodium's unique water-soluble formulation delivers critical clinical advantages for both patients and healthcare providers.
Water-soluble formulation — eliminates need for propylene glycol solvent
Allows significantly faster IV infusion rates vs. conventional phenytoin
Substantially reduced risk of local tissue damage and phlebitis
Safe for IM administration, unlike conventional phenytoin
Compatible with commonly used IV solutions (NS, D5W)
Consistent bioavailability with predictable phenytoin conversion kinetics
Detailed Specifications
Rigidly Compliant with Standard Pharmacopoeia (USP / EP / IP)
| Sr. | Test Parameter | Global Specification Validation |
|---|---|---|
| 1 | Description | White to off-white powder |
| 2 | Solubility | Freely soluble in water, sparingly soluble in alcohol |
| 3 | Identification | IR spectrum conforms to reference standard (USP) |
| 4 | pH (1% solution) | 8.0 – 9.0 |
| 5 | Water Content (KF) | Not more than 3.0% |
| 6 | Related Substances | Phenytoin: NMT 0.5%, Any individual: NMT 0.2%, Total: NMT 1.0% |
| 7 | Assay (HPLC) | 98.0% – 102.0% (on anhydrous basis) |
Why Choose Our Phenytoin Sodium
Regulatory Compliance
USFDA DMF filed with full compliance to USP, EP, and IP pharmacopeial standards, ensuring market access across regulated territories globally.
High Purity API
Advanced multi-step synthesis with stringent quality control ensuring consistent purity and a low impurity profile (Total impurities: NMT 1.0%).
Global Supply Capability
Reliable supply chain with complete documentation support including stability data, CoA, and WHO-GMP certificates for seamless regulatory submissions.
Technical Excellence
Dedicated scientific team for formulation guidance, regulatory queries, and customer-specific analytical and documentation requirements.
Packaging Standard
Double LDPE inner bags in HDPE / Fiber drums. Available in 5 kg, 10 kg, and 25 kg pack sizes. Custom packaging available.
Storage Protocol
Store at controlled room temperature (20–25°C), protected from light and moisture. Keep in tightly globally sealed containers.
Validated Shelf Life
36 Months from date of manufacture under recommended storage conditions. Re-testing required before use beyond this period.
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Legal Disclaimer: This technical information is intended exclusively for authorized B2B pharmaceutical manufacturing and research. This API is not a finished dosage form. Severe strict compliance and specifications are subject to revision without prior notice.