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CELOPRE® MK4M

CELOPRE® MK4M
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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 3,000 – 5,000 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® MK4M Universal Pharmaceutical Applications

Celopre® MK4M is a “universal pharmaceutical excipient,” its core applications are: coating, binding, and basic sustained release (not strictly controlled release).

  • Suspending Agent (Oral Solution / Syrup)

    Suspending Agent (Oral Solution / Syrup)

    Celopre® MK4M is effectively preventing sedimentation while imparting a subtle structural texture. Compared to high-viscosity products, its viscosity profile is specifically tailored to optimize the processing and filling of liquid-based systems.

    Advantages

    • Specifically formulated for suspension preparations, oral liquids, and syrups
    • Effectively prevents sedimentation
    • Imparts a subtle structural texture
    • Better suited for liquid systems than high-viscosity products
    • Balances both stability and flow properties
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  • As A Binder for Wet Granulation

    As A Binder for Wet Granulation

    Celopre® MK4M effectively enhances granule strength and improves tableting performance. Easier to handle than high-viscosity products, yet offering more reliable binding strength than low-viscosity alternatives, it represents striking the perfect balance between binding efficacy and processing convenience.

    Advantages

    • Specifically designed for wet granulation
    • Enhances granule strength and improves tableting performance
    • Moderate viscosity (3,000–5,000 mPa·s)
    • Reliable binding strength with easy dispersibility
    • Process-friendly and highly convenient to handle
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  • Tablet Film Coating (Aqueous Coating Systems

    Tablet Film Coating (Aqueous Coating Systems

    Compared to lower-viscosity products (3–6 cps), Celopre® MK4M offers superior film strength; conversely, compared to higher-viscosity products, it facilitates easier spray application. It effectively enhances tablet aesthetics, provides moisture protection, and improves ease of swallowing—making it a highly versatile, “process-friendly” coating-grade HPMC suitable for a wide range of manufacturing conditions.

    Advantages

    • Dedicated to tablet film coating; compatible with aqueous systems
    • Superior film strength compared to low-viscosity products (3–6 cps)
    • Easier spray application compared to high-viscosity products
    • Enhances appearance, provides moisture protection, and improves swallowability
    • High process tolerance; versatile and adaptable different conditions
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