Pharmaceutical Chemistry

Ornidazole

Formula: C7H10ClN3O3 GOST/CAS: CAS 16773-42-5

Ornidazole is an antiprotozoal and antibacterial agent derived from 5-nitroimidazole. The substance is a white to light yellow crystalline powder, highly effective against a wide range of anaerobic microorganisms and protozoa. Due to its high bioavailability and stable physicochemical properties, Ornidazole serves as an indispensable active pharmaceutical ingredient (API) for the manufacturing of finished dosage forms, including tablets, capsules, and infusion solutions, within the modern pharmaceutical industry.

Applications

Solid Dosage Form Production: Used as an Active Pharmaceutical Ingredient (API) for manufacturing oral tablets, film-coated tablets, and capsules aimed at treating systemic infections.

Infusion Solution Manufacturing: Applied in formulating sterile formulations for intravenous administration, primarily utilized in clinical settings for severe anaerobic infections.

Topical & Soft Dosage Forms: Can be incorporated into complex ointments, suppositories, and gels for localized applications in gynecology and dermatology.

Key Advantages

High Purity Grade (99.0%+): Strict compliance with international pharmacopoeia standards (Ph.Eur., USP) guarantees minimal impurity profiles and high safety of the finished drug product.

Broad Spectrum of Activity: Exceptional efficacy against protozoa such as Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia, as well as anaerobic bacteria including Bacteroides spp. and Clostridium spp.

Processing Stability: The powder exhibits excellent flowability and a stable crystalline structure, simplifying direct compression and granulation processes.

Reliable Bioavailability: Consistent physicochemical parameters ensure predictable dissolution profiles and rapid absorption rates in finished formulations.

Storage & Transportation

Store in dry, light-protected, and cool warehouse facilities in tightly closed original packaging.
Recommended storage temperature: +15 °C to +25 °C. Avoid sudden temperature fluctuations and high humidity.
Keep out of reach of children; store separately from chemically active, oxidizing, or strong-smelling substances.
Transportable via all types of covered transport vehicles, adhering to temperature controls and protection against atmospheric precipitation. Classified as non-hazardous for standard API transport.
Shelf Life: 3–5 years from the manufacturing date (depending on the manufacturer and subject to original seal integrity).

Technical Specifications

Appearance White to pale yellow crystalline powder

Assay (On Dried Basis) 99.0% – 101.0%

Melting Point 88 °C – 92 °C

Loss on Drying Not more than 0.5%

Sulfated Ash Not more than 0.1%

Heavy Metals Not more than 20 ppm

Residual Solvents Meets ICH requirements

Supply info

Sealed double polyethylene bags enclosed within fiber drums (cardboard drums) of 25 kg net weight.
Custom packaging and batch sizing are available upon request for pilot and trial production runs.
Every batch is accompanied by a Certificate of Analysis (COA), Quality Passport, and GMP / DMF documentation.

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