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CELOPRE® ME15M

CELOPRE® ME15M
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CELOPRE® ME15M is a USP Pharmacopeia-grade, high-methoxy, medium-to-high viscosity E-series HPMC (approx. 13,000–17,000 cP), it features excellent film-forming properties and structural strength, making it suitable for immediate-release formulations.

Test Item Unit Specification Method
Appearance   White to Yellowish white Visual
Identification A   Conforms USP
Identification B   Conforms USP
Identification C   Conforms USP
pH   5.5-8.0 USP
Apparent Viscosity cP 13,000-17,000 USP
Loss on drying % 5.0 Max USP
Residue on ignition % 1.5 Max USP
Heavy metals % 0.001 Max USP
Arsenic ppm 3.0 Max USP
Methoxyl Content % 28.0 – 30.0 USP
Hydroxypropoxyl content % 7.5 – 12.0 USP
Total Microbial count cfu/g Max 1000  
Total Mould and Yeast cfu/g Max 100  
E.Coli   Negative

Remark: This product complies with the specifications described in the current pharmacopeia.

Package

Pack in drums, net weight 25kg per drum.

Storage

Store in sealed container, keep away from sunlight & moisture.

CELOPRE® ME15M Applications

CELOPRE® ME15M primarily used for pharmaceutical film coating and tablet binding.

  • Pharmaceutical Film Coating

    Pharmaceutical Film Coating

    CELOPRE® ME15M is suitable for coating of tablets and capsules.

    Advantages

    • Thicker, more abrasion-resistant film
    • Enhanced appearance
    • Improved stability
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  • Tablet Binder

    Tablet Binder

    The primary application of CELOPRE® ME15M is as a tablet binder, suitable for both wet granulation and direct compression.

    Advantages

    • Enhances Tablet Strength
    • Improves Tableting Performance
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  • Immediate-release Tablets (IR systems)

    Immediate-release Tablets (IR systems)

    CELOPRE® ME15M is utilized for disintegration control and API dispersion.

    Advantages

    • Rapid release, meeting immediate-release requirements
    • Does not delay disintegration, ensuring rapid drug dissolution
    • Promotes uniform API dispersion, ensuring content uniformity
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