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Metronidazole
(Base & HCl)

To guarantee the highest purity and efficacy, we adhere to strict global standards

HUMAN API

Metronidazole (Base & HCl)

Metronidazole is a critical Active Pharmaceutical Ingredient (API) belonging to the Nitroimidazole Antimicrobials class. It is distinguished by its potent, targeted activity against a wide range of anaerobic bacteria and protozoa. We supply Metronidazole in two essential forms: the Base form for oral and topical/vaginal formulations, and the highly water-soluble Hydrochloride (HCl) salt, required for sterile injectable solutions.

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).
A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.
A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.
Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).
Therapeutic Class:
Antiprotozoal and Anaerobic Antibacterial Agent.
Mechanism of Action:
A prodrug that, upon reduction within anaerobic organisms, generates short-lived cytotoxic free radicals. These disrupt DNA and nucleic acid synthesis, leading to potent cell death.
Clinical Application:
Treatment of systemic anaerobic bacterial infections (e.g., C. difficile, Bacteroides), protozoal infections (e.g., amoebiasis, giardiasis, trichomoniasis), and topical treatment of Rosacea.
Competitive Advantage:
Highly effective against pathogens often resistant to common antibiotics; essential for treating complex polymicrobial infections.
Base

Oral tablets, capsules, suspensions, suppositories, and topical/vaginal creams/gels.

Suitable for solid and semi-solid formulations; provides predictable dissolution profiles for oral dosing.

Hydrochloride (HCl)

Sterile injectable solutions (for IV infusion).

High Water Solubility ensures rapid and complete dissolution necessary for preparing clear, sterile, high-concentration parenteral solutions.

Regulatory Compliance

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).

Certificate of Analysis (CoA)

A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.

Drug Master File (DMF)

A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.

Manufacturing Operations

Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).

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