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Pharmaceutical Chemistry
Ofloxacin
Formula:
C18H20FN3O4
GOST/CAS:
CAS 82419-36-1
Ofloxacin is a highly effective Active Pharmaceutical Ingredient (API) belonging to the fluoroquinolone class (second-generation) of broad-spectrum antimicrobial agents. The product is a white to pale yellowish-white crystalline powder, odorless, with a bitter taste. It exhibits strong bactericidal activity by inhibiting the bacterial DNA gyrase enzyme. Ofloxacin is an essential raw material for manufacturing Finished Dosage Forms (FDF) in the modern pharmaceutical industry.
Applications
Production of Oral Dosage Forms: Used as the core active ingredient for manufacturing tablets, capsules, and suspensions intended for treating respiratory, gastrointestinal, and urinary tract infections.
Production of Injectable Solutions: Applied in the formulation of sterile solutions for intravenous infusions in hospital healthcare segments.
Ophthalmic and Otic Drops: Serves as a base component in ophthalmology and otolaryngology for creating localized antibacterial drops and ointments (for treating conjunctivitis, otitis, etc.).
Veterinary Medicine: Widely used in the manufacture of veterinary antibacterial products to treat a broad range of infections in livestock and domestic animals.
Key Advantages
Broad Spectrum and High Potency: Effective against most Gram-negative and Gram-positive microorganisms, including strains resistant to other classes of antibiotics.
High Chemical Stability: Possesses excellent physicochemical properties, ensuring the stability of the active substance within the finished product throughout its entire shelf life.
Excellent Bioavailability: Easily undergoes pharmaceutical processing (such as granulation and blending), providing high solubility and nearly 100% bioavailability in finished dosage forms.
Compliance with Global Standards: The substance is manufactured strictly under GMP conditions and fully complies with the strict requirements of leading pharmacopoeias (EP, USP, BP).
Storage & Transportation
- Store in dry, clean, cool warehouse areas in the tightly sealed original container. Must be strictly protected from direct sunlight and moisture.
- Recommended storage temperature: +15°C to +25°C.
- Transportation is permitted via all types of covered transport, provided that container airtightness and sun protection are maintained. The product is not classified as hazardous cargo (Non-ADR).
- Shelf Life: 3 to 5 years from the date of manufacture (depending on the manufacturer), subject to maintaining tight seal conditions.
Technical Specifications
Appearance
White to pale yellow crystalline powder, light-sensitive.
Assay (Active Content)
98.5% – 101.5% (calculated on the dried substance)
Melting Point
250°C – 257°C (with decomposition)
Loss on Drying
Not more than 0.2%
Sulfated Ash
Not more than 0.1%
Heavy Metals
Not more than 20 ppm
Solubility
Soluble in glacial acetic acid, sparingly soluble in water, moderately soluble in methanol.
Supply info
- Hermetically sealed plastic or fiber drums of 25 kg net weight, equipped with double inner polyethylene liners.
- Smaller packaging configurations are available upon request for laboratory testing and trial batches.