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CELOPRE® MK100M

CELOPRE® MK100M
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Test Item Unit Specification Standard
Characters Conforms EP/USP NF
Identification A Conforms EP/USP NF
Identification B Conforms EP/USP NF
Identification C Conforms EP/USP NF
Identification D Conforms EP/USP NF
Identification E Conforms EP/USP NF
Identification F Conforms EP/USP NF
pH 5.5-8.0 EP/USP NF
Apparent Viscosity mPa.s 80,000 – 120,000 EP/USP NF
Appearance of Solution Conforms EP/USP NF
Chlorides % Max 0.5 EP/USP NF
Loss on drying % 5.0 Max EP/USP NF
Residue on ignition % 1.0 Max EP/USP NF
Heavy metals % Not more than 0.001 EP/USP NF
Methoxyl Content % 19.0 – 24.0
Hydroxypropoxyl content % 4.0 – 12.0
Total Microbial Count cfu/g Max 1000
Total Mould and Yeast cfu/g Max 100
E.Coli Negative

 

CELOPRE® MK100M Pharmaceutical Applications

CELOPRE® MK100M is a pharmaceutical-grade HPMC suitable for use in film coating and sustained-release applications. It features medium-to-high viscosity and is designed for oral dosage formulations; it is not suitable for use in construction materials.

  • Sustained & Controlled-release Matrix Tablets

    Sustained & Controlled-release Matrix Tablets

    Celopre® MK100M can contact with water, a highly viscous gel layer rapidly forms on the tablet surface, effectively regulating water ingress and the rate of drug diffusion to ensure prolonged, stable release.

    Advantages

    • Specifically designed for hydrogel matrix tablets; compatible with sustained-release and controlled-release systems
    • Rapidly forms a highly viscous gel layer upon contact with water
    • Stable gel layer ensures more controllable drug release
    • High-viscosity formulation suitable for sustained-release cycles ranging from 8 to 24 hours
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  • High-API-load Sustained-release Systems

    High-API-load Sustained-release Systems

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