Pazufloxacin is a synthetic fluoroquinolone antibacterial active pharmaceutical ingredient (API). It belongs to the quinolone class of antimicrobial compounds and is characterized by a fluorinated quinolone structure with a 1-aminocyclopropyl substituent.
Pazufloxacin has the CAS Number 127045-41-4, molecular formula C16H15FN2O4, and molecular weight 318.30 g/mol. FDA substance information confirms its absolute stereochemistry and one defined stereocenter.
For pharmaceutical use, Pazufloxacin is commonly encountered as Pazufloxacin Mesilate (Pazufloxacin Mesylate). Pazufloxacin Mesilate has CAS Number 163680-77-1, molecular formula C17H19FN2O7S, and molecular weight approximately 414.4 g/mol.
Pazufloxacin Mesilate is the mesilate salt of Pazufloxacin and is an important pharmaceutical form used for injectable preparations. The Japanese Pharmacopoeia includes an official monograph for Pazufloxacin Mesilate with identification, purity and assay testing.
The API requires appropriate control of identity, assay, related substances, water or drying characteristics, residual solvents and other applicable quality attributes. Chromatographic testing is particularly important for confirming the purity and assay of the active pharmaceutical ingredient.
Pazufloxacin is a chiral fluoroquinolone molecule with one defined stereocenter. FDA's Global Substance Registration System identifies the substance as having absolute stereochemistry with 1/1 defined stereocenters.
Pazufloxacin has a molecular weight of 318.30 g/mol, while Pazufloxacin Mesilate has a molecular weight of approximately 414.4 g/mol. These values should not be interchanged when preparing a pharmaceutical product specification.
Quality control of Pazufloxacin API generally includes identification by suitable analytical methods, chromatographic assay, related-substance determination and control of physical and chemical properties.
For Pazufloxacin Mesilate, the Japanese Pharmacopoeia describes an HPLC assay procedure using an internal standard and UV detection at 254 nm. The monograph specifies an octadecylsilanized silica-gel column and controlled chromatographic conditions for determination of Pazufloxacin Mesilate.
This pharmacopoeial method provides a reliable basis for assay testing, while the applicable finished API specification should be followed for numerical acceptance limits.
Pazufloxacin is a fluoroquinolone antibacterial API developed for pharmaceutical applications involving bacterial infections. Pazufloxacin and its mesilate salt are particularly associated with injectable pharmaceutical formulations.
The API is relevant to pharmaceutical research, antimicrobial drug development, analytical reference work and manufacturing programs involving fluoroquinolone-based pharmaceutical products.
Manufacturing of Pazufloxacin API requires controlled chemical synthesis followed by purification, crystallization or salt formation, drying and appropriate packaging. The manufacturing process must control related substances and ensure the required stereochemical form of the active ingredient.
For Pazufloxacin Mesilate, the salt-forming step is important because the mesilate form has a different molecular formula and molecular weight from the Pazufloxacin active moiety.
Pazufloxacin API should be stored according to the approved drug-substance specification and validated stability conditions. Appropriate protection from moisture, excessive heat and unsuitable environmental conditions should be maintained.
Packaging should be selected to preserve the chemical and physical quality of the API throughout its approved storage period.
Pazufloxacin is a specialized fluoroquinolone pharmaceutical API suitable for pharmaceutical development and commercial manufacturing applications. Pazufloxacin Mesilate should be specified separately from the parent Pazufloxacin API to avoid confusion regarding CAS number, molecular formula and molecular weight.
For commercial pharmaceutical applications, the applicable pharmacopoeial monograph and approved API specification should be used for final release testing.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 0.10% |