| 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 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.
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.
