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