Sugammadex Sodium API is the sodium salt of sugammadex, a modified gamma-cyclodextrin derivative developed as a selective relaxant binding agent. It is used for the reversal of neuromuscular blockade induced by rocuronium and vecuronium during surgical procedures. Sugammadex Sodium is chemically identified by CAS Number 343306-79-6, molecular formula C₇₂H₁₀₄Na₈O₄₈S₈, and molecular weight approximately 2178.0 g/mol.
Sugammadex is an octasaccharide derivative structurally related to gamma-cyclodextrin. The sodium form contains eight sodium ions associated with the carboxylate groups of the molecule. Its hydrophilic exterior and hydrophobic cavity enable it to encapsulate steroidal neuromuscular-blocking agents, particularly rocuronium and vecuronium.
Sugammadex Sodium has the molecular formula C₇₂H₁₀₄Na₈O₄₈S₈ and molecular weight 2178.0 g/mol. The parent compound, Sugammadex, has CAS 343306-71-8 and molecular weight approximately 2002.2 g/mol.
Sugammadex Sodium is used as a neuromuscular blockade reversal agent. It forms a stable complex with rocuronium or vecuronium, reducing the amount of free neuromuscular-blocking agent available at the neuromuscular junction and thereby facilitating recovery of neuromuscular function.
Its selective binding mechanism differentiates Sugammadex from traditional acetylcholinesterase inhibitors used for reversal of neuromuscular blockade.
Sugammadex forms a tight complex with steroidal neuromuscular-blocking agents through encapsulation within its modified cyclodextrin cavity. This reduces the free concentration of rocuronium or vecuronium in plasma and creates a concentration gradient that promotes movement of the neuromuscular-blocking agent away from the neuromuscular junction.
Quality control of Sugammadex Sodium requires identity, assay and related-substance testing together with control of water, sodium content and residual process solvents. HPLC is used for assay and related-substance analysis.
Because Sugammadex Sodium is a highly functionalized carbohydrate derivative, its analytical profile should distinguish the active Sugammadex component from process-related derivatives such as monohydroxy Sugammadex. PubChem separately identifies monohydroxy Sugammadex Sodium as a related substance.
Swapnroop Drugs and Pharmaceuticals provides pharmaceutical API manufacturing capabilities supported by controlled processing, analytical testing and quality documentation.
Sugammadex Sodium can be evaluated according to applicable pharmaceutical specifications, customer requirements and validated analytical procedures, with particular attention to assay, related substances, water content and inorganic/residual components.
Sugammadex Sodium should be protected from excessive moisture and stored under controlled conditions in suitable moisture-protective packaging. Actual storage conditions should follow the validated stability data and approved product specification.
Depending on applicable requirements, documentation may include:
Sugammadex Sodium requires careful control of chemical identity, assay, related substances, water content and other quality attributes associated with its highly functionalized cyclodextrin structure. Swapnroop focuses on controlled pharmaceutical API manufacturing, analytical quality evaluation and documentation support for specialized pharmaceutical requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 94.0–102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 1.0% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 7.0–8.0 |
| Individual Impurity | NMT 0.30% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |