METRONIDAZOLE

Metronidazole is a potent antibacterial and antiprotozoal API belonging to the nitroimidazole class. It is widely used for the treatment of anaerobic bacterial infections and protozoal diseases such as amoebiasis, giardiasis, trichomoniasis, and bacterial vaginosis.

At Bluepill Express, we manufacture and export pharmacopeial-grade Metronidazole API compliant with IP, BP, USP, and EP standards. Our manufacturing facilities are WHO-GMP, ISO, and cGMP certified, ensuring high purity (≥99%), low residual solvents, and uniform particle size distribution for excellent formulation stability.

Metronidazole is a WHO Essential Medicine and remains one of the most prescribed APIs globally due to its broad-spectrum antimicrobial activity, cost-effectiveness, and versatile formulation compatibility (tablets, capsules, suspensions, creams, gels, and injections).

Therapeutic Applications:

• Treatment of anaerobic infections (dental, gynecological, and gastrointestinal)
• Management of amoebiasis and giardiasis
• Treatment of trichomoniasis and bacterial vaginosis
• Adjunct therapy for H. pylori infections in combination regimens
• Topical use in dermatology for rosacea and acne-like eruptions

Mechanism of Action:

Metronidazole enters microbial cells and undergoes reduction of its nitro group by anaerobic organisms, forming reactive metabolites. These intermediates interact with microbial DNA, inhibiting nucleic acid synthesis, resulting in cell death. It is highly effective against obligate anaerobes and protozoa.

Technical Specifications:

• Chemical Name: 2-(2-Methyl-5-nitro-1H-imidazol-1-yl) ethanol
• Molecular Formula: C₆H₉N₃O₃
• Molecular Weight: 171.15 g/mol
• CAS Number: 443-48-1
• Appearance: White to light yellow crystalline powder
• Assay (on dried basis): NLT 98.0% and NMT 101.0%
• Solubility: Slightly soluble in water; soluble in alcohol and chloroform
• Melting Point: 158°C – 162°C
• Storage Conditions: Store below 30°C, protected from light and moisture

Pharmacological Classification:

• Therapeutic Class: Antibacterial / Antiprotozoal
• Pharmacopoeial Standards: IP / BP / USP / EP
• Dosage Form Applications: Tablets, Capsules, Injections, Suspensions, Topical Creams, and Gels

Manufacturing Excellence – Bluepill Express:

• Manufactured under WHO-GMP, ISO 9001:2015, and cGMP certifications
• High assay purity (≥99%) with minimal impurities
• HPLC and GC tested for residual solvents and heavy metals
• DMF-ready with regulatory documentation available
• Consistent bulk density and flow properties for easy formulation
• Stable crystalline form suitable for both oral and parenteral formulations

Advantages of Bluepill Express Metronidazole API:

• Pharmacopeial-grade compliant with IP/BP/USP/EP
• DMF, COA, MSDS, and TDS support for regulatory needs
• Globally accepted quality and stability data
• Customized particle sizing available (micronized & non-micronized)
• Bulk export packaging options with long shelf life

Packaging & Export Details:

• Packaging Sizes: 5 kg, 10 kg, and 25 kg HDPE drums with double LDPE liners
• Labeling: As per international pharmacopeial and export norms
• Shelf Life: 36 months under standard storage conditions
• Export Regions: Africa, Asia, Europe, Latin America, and the Middle East
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Stability Data Sheet
  • Technical Data Sheet (TDS)
  • Drug Master File (DMF) upon request