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CELOPRE® MK15M

CELOPRE® MK15M
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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 13,000 – 17,000 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® MK15M Pharmaceutical Applications

Pharmaceutical / Food Excipient Grade, Medium-to-High Viscosity HPMC (approx. 15,000 mPa·s)

Key Features:

✔ Compliant with EP / USP-NF (Suitable for use in pharmaceutical and food systems)
✔ Viscosity: 13,000–17,000 mPa·s (Characterized by structural viscosity rather than low-viscosity flow properties)
✔ Methoxyl + Hydroxypropoxyl Content: Within the standard pharmaceutical range
✔ Microbiological Purity: TAMC ≤ 1000 CFU/g, Molds ≤ 100 CFU/g (Suitable for use in oral dosage forms)

  • Film Coating in Aqueous Coating Systems

    Film Coating in Aqueous Coating Systems

    Celopre® MK15M is effectively serves as a foundational film for controlled-release and sustained-release formulations, significantly enhancing the visual appearance of tablets while providing reliable moisture protection for Active Pharmaceutical Ingredients (APIs), thereby comprehensively improving tablet quality and stability.

    Advantages

    • Excellent Film-Forming Properties:With a viscosity reaching 15,000 mPa·s, it ensures the formation of a uniform, robust coating film with optimal mechanical strength.
    • Reliable Film Integrity: It prevents the coating layer from becoming brittle or prone to breakage—issues often associated with overly dilute coating solutions.
    • High Process Adaptability: Its moderate viscosity facilitates smooth spray application, avoiding the difficulties or nozzle clogging that can arise from excessively high viscosity.
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  • Plant-based Capsule Shell

    Plant-based Capsule Shell

    Celopre® MK15M is suitable for the production of plant-based capsules (vegetarian capsules); it serves as a substitute for gelatin, providing structural support while meeting standard performance requirements.

    Advantages

    • Vegetarian source; serves as a gelatin substitute
    • Provides stable structural support
    • Meets viscosity specifications; compatible with standard manufacturing processes
    • Microbiological indicators comply with regulatory requirements
    • Positioning: Offers good general usability, though it is not an optimally customized grade
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