MINOCYCLINE

MINOCYCLINE

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    Description

    ANTIBIOTIC | ANTIINFECTIVE AGENT
    TETRACYCLINE ANTIBIOTIC

    Minocycline is a second-generation, semisynthetic tetracycline antibiotic with broad-spectrum activity against gram-positive and gram-negative bacteria.

    Structural modifications improve its potency over earlier tetracyclines.

    Available in oral, topical, IV, and subgingival forms, it enters bacteria via porin channels and blocks protein synthesis by inhibiting tRNA binding to the 30S ribosome.

    Its long half-life (11–23 h) supports sustained levels, making it effective for both acute and chronic infections.

    • CAS number: 13614-98-7.
    • Common indications: treatment of acne and other susceptible bacterial infections.
    • Product status: commercial.
    • Available grades: non-micronized.
    • Documentation: CoA, CEP, DMF.
    minociclina f

    Properties

    • Physical appearance: yellow powder
    • Assay by HPLC: 91.9%
    • Sum of impurities: 3.2%
    • Specific optic rotation: 201º
    • pH: 8.1

    SF API Advantages

    • Manufactured in Europe.
    • Complies with both EP and USP monograph.
    • Consistent quality and batch-to-batch reproducibility.
    • GMP-compliant manufacturing process.
    • Full regulatory support and documentation available.
    • Robust supply chain with fast and reliable global distribution.
    • Technical support and customer service.
    • Extensive commercial experience.

    Routes of Administration

    • Oral.
    • Topical.
    • Intravenous.

    Pharmacokinetic Notes

    • Half life: 8 hours.
    • High bioavailability: 70%.
    • Fast absorption: Tmax 2-3 h after administration.

    Final Product Innovator Presentations

    • Topical: aerosol, foam 1.5% and 4% base.
    • Injectable: injection 100 mg base/vial.
    • Oral:
      • Tablets: 50, 75 and 100 mg.
      • Tablet, extended release: 45, 55, 65, 80, 90, 105, 115 and 135 mg.
      • Hard capsules: 100 mg.

    Certifications of the Site

    logo-GMP
    GMP
    EMA
    logo-USFDA
    FDA
    logo-KFDA
    KFDA
    PMDA
    Infarmed (National Authority of Medicines and Health Products)
    ISO14001

    Certifications of the API

    GMP
    PMDA
    logo-KFDA
    KFDA
    logo-TFDA
    TFDA

    Our API

    Minocycline

    • Our API minocycline is manufactured in accordance with cGMP and stringent international quality standards.

    Quality

    • Our quality control follows every stage from development of analytical methods to the control of manufacturing process, enabling us to achieve rigorous and stringent results in accordance with injectables parameters, even under aseptic conditions.

    Samples availables

    destacado
    MINOCYCLINE

    PATENT PROTECTION

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