Levofloxacin Hemihydrate Cas 138199-71-0
Specification
Items | Specifications | Results |
Appearance | Light yellowish-white to Yellow-white crystals or crystalline powder | Light yellowish-white crystalline powder |
Identification | (A)IR The spectrum obtained from sample consists with that obtained from Levofloxacin RS | Complies |
(B)HPLC The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. | Complies |
ASSAY(on the anhydrous basis) | 98.0% ~ 102.0% of C18H20FN3O4 | 99.8% |
Residue on ignition | NMT 0.2% | 0.02% |
Organic impurities | N-Desmethyl levofloxacin NMT 0.3% | <0.02% |
Diamine derivative NMT 0.3% | <0.02% |
Levofloxacin N-oxide NMT 0.3% | <0.02% |
9-Desfluoro levofloxacin NMT 0.3% | <0.02% |
D-Isomer NMT 0.8% | 0.20% |
Any unknown impurity NMT 0.1% | 0.04%(RRT:0.42) 0.04%(RRT:1.69) |
Total impurities (except the D-isomer) NMT 0.5% | 0.08% |
Levofloxacin related compoundA (N-Desmethyl levofloxacin) | NMT 0.20% | <0.03% |
Levofloxacin related compound B | NMT 0.13% | <0.03% |
Any other impurity | NMT 0.10% | 0.03%(RRT:0.44) 0.04%(RRT:0.77) 0.04%(RRT:2.57) |
Total impurities | NMT 0.50% | 0.11% |
Specific rotation(at 20℃) | -92º～-106º | -101.5º |
Water | 2.0%～3.0% | 2.5% |
Chloroform | NMT 60ppm | 25ppm |
Ethanol | NMT 1000ppm | 364ppm |
DMSO | NMT 1000ppm | <100ppm(LOD) |
Conclusion | The product conforms to the above specifications. |
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Levofloxacin hemihydrate is the specific crystalline form of the antibiotic drug levofloxacin, where each molecule of levofloxacin is associated with half a molecule of water (i.e., a 2:1 ratio of levofloxacin to water). Its chemical formula is often written as C₁₈H₂₀FN₃O₄·½H₂O.
Levofloxacin itself is a synthetic fluoroquinolone antibiotic. It is the optically active L-isomer of ofloxacin, which gives it greater antibacterial potency.
Hemihydrate refers to its solid-state form, a key aspect in pharmaceutical chemistry that influences properties like stability, solubility, and manufacturability.
Primary (Medical) Use
Its primary use is as a broad-spectrum antibacterial agent. It works by inhibiting bacterial DNA gyrase and topoisomerase IV enzymes, essential for DNA replication. It is used to treat infections such as:
Uses in Chemical and Pharmaceutical Contexts
In the realm of chemistry (particularly pharmaceutical chemistry and process chemistry), levofloxacin hemihydrate is significant for the following reasons:
1. Solid Form Selection and Polymorphism
Objective: To identify the most thermodynamically stable and pharmaceutically acceptable crystalline form of the active pharmaceutical ingredient (API).
Role: The hemihydrate is the preferred commercial form of levofloxacin. Chemists work to ensure consistent crystallization to this form, as different hydrates or polymorphs can have varying solubilities, dissolution rates, and stability, which directly impact drug efficacy and shelf life.
2. Process Chemistry & Scale-up
Synthesis: Chemical engineers and process chemists develop and optimize the multi-step synthetic route to produce levofloxacin, culminating in the final step where the hemihydrate is crystallized.
Crystallization Engineering: The precise control of conditions (solvent, temperature, cooling rate, water activity) to reliably produce the hemihydrate on an industrial scale is a critical chemical operation.
3. Analytical Chemistry & Quality Control (QC)
4. Formulation Development
Compatibility: Chemical studies assess how the levofloxacin hemihydrate interacts with excipients (fillers, binders) in tablets or IV solutions.
Stability Studies: Chemists monitor the chemical stability of the hemihydrate form under various conditions (heat, humidity, light) to define storage requirements and shelf life. A key concern is preventing unwanted phase transformations.
5. Intellectual Property & Regulatory Filings
The specific hemihydrate form is a definable chemical entity. Its characterization data, manufacturing process, and stability profile are critical components of regulatory dossiers (e.g., to the FDA or EMA). Patent protection often specifically claims the hemihydrate form.
Key Chemical Property: Hydrate Stability
The "hemihydrate" nature is its defining chemical feature. The water molecules are incorporated into the crystal lattice. This form is typically chosen because:
It is less hygroscopic than an amorphous form.
It often has better chemical and physical stability than the anhydrous form under typical storage conditions.
It provides a reproducible dissolution profile, which is crucial for consistent drug absorption.
Summary
While levofloxacin hemihydrate is clinically an antibiotic, from a chemical perspective, it is:
A case study in solid-state chemistry and polymorphism.
The target output of an optimized chemical synthesis and crystallization process.
The subject of extensive analytical characterization for quality assurance.
A key factor in pharmaceutical formulation and stability.
Its "uses in chemistry" are therefore centered around its development, manufacturing, analysis, and control as a stable, effective, and reproducible active pharmaceutical ingredient (API).
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