Sevoflurane is a volatile, nonflammable and nonexplosive halogenated general inhalation anesthetic used for induction and maintenance of general anesthesia. It is administered by vaporization through an appropriate anesthesia system. FDA and DailyMed identify Sevoflurane USP as fluoromethyl 2,2,2-trifluoro-1-(trifluoromethyl)ethyl ether.
Sevoflurane is a well-characterized pharmaceutical substance with an established USP-NF monograph. The USP definition requires Sevoflurane to contain NLT 99.97% and NMT 100.00% of C₄H₃F₇O.
Sevoflurane is a small fluorinated ether molecule and is achiral, with no defined stereocenters. FDA GSRS identifies the molecular formula as C₄H₃F₇O and molecular weight as approximately 200.06, while the USP and FDA product labeling give 200.05 g/mol.
Key identity information:
Sevoflurane is chemically identified as 1,1,1,3,3,3-hexafluoro-2-(fluoromethoxy)propane. Its molecular structure contains seven fluorine atoms and an ether linkage.
Its high volatility makes it suitable for delivery through calibrated vaporizers. FDA labeling reports a boiling point of 58.6°C at 760 mm Hg, specific gravity of 1.520–1.525 at 20°C, and vapor pressures of 157 mm Hg at 20°C, 197 mm Hg at 25°C and 317 mm Hg at 36°C.
Sevoflurane produces general anesthesia through effects on multiple neuronal ion channels and signaling systems within the central nervous system. Its pharmacological effects include loss of consciousness, immobility and reduced responsiveness to surgical stimuli.
The precise molecular mechanism of general anesthetic action is complex and involves modulation of several ligand-gated and ion-channel systems rather than a single pharmacological target.
Sevoflurane is used for:
Its low blood/gas partition coefficient contributes to relatively rapid changes in anesthetic depth. FDA labeling reports a blood/gas partition coefficient of approximately 0.63–0.69 at 37°C.
Sevoflurane has established pharmacopoeial quality controls. USP identifies IR identification, refractive index, acidity/alkalinity, water, fluoride and related-compound controls among the relevant analytical characteristics, with the USP reference-standard system including Sevoflurane RS and Related Compound A, B and C standards.
Important quality-control parameters include:
The USP assay requirement is 99.97%–100.00%.
Sevoflurane is manufactured by controlled chemical synthesis followed by purification and stringent control of volatile and trace impurities. Because it is a volatile liquid, manufacturing and packaging require appropriate closed-system handling and controls against contamination, evaporation and moisture exposure.
The finished API must comply with applicable pharmacopoeial requirements, including the USP monograph where USP-grade material is claimed.
Sevoflurane is a clear, colorless volatile liquid. It has a molecular weight of 200.05 g/mol and boils at 58.6°C at 760 mm Hg. Its specific gravity at 20°C is 1.520–1.525.
The USP monograph specifies a refractive index of 1.2745–1.2760 at 20°C.
Sevoflurane is practically insoluble in water but has appreciable solubility in organic/lipid environments. Its water/gas partition coefficient at 37°C is approximately 0.36, while its olive-oil/gas partition coefficient is 47–54.
USP information specifies that Sevoflurane should be preserved in tight, light-resistant containers and stored at controlled room temperature. The container should be securely closed after use.
Because Sevoflurane is highly volatile, packaging integrity is particularly important to maintain assay, purity and physical-property requirements throughout storage.
A commercial Sevoflurane API documentation package may include:
Sevoflurane requires tight control of assay, volatile impurities, water, acidity/alkalinity, refractive index and related substances. Its established USP-NF monograph provides clear quality requirements, including a 99.97%–100.00% assay range, making pharmacopoeial compliance and appropriate analytical testing essential for pharmaceutical-grade Sevoflurane.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 99.97–100.00% |
| Total Impurities | NMT 0.03% |
| Water Content | NMT 0.10% |