USP/EP/NF Pharmacopoeia Grade HPMC — Low-Methoxyl Type (K-type) + Ultra-High Viscosity (25,000–35,000 mPa·s)
| 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 | 25,000 – 35,000 | 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 |
High-Viscosity K-Type Pharmaceutical HPMC for Controlled Release: A controlled-release matrix material characterized by slower hydration, superior erosion resistance, and enhanced stability.
CELOPRE® MK30M is primarily utilized in 12-hour and 24-hour sustained-release tablets, as well as controlled-release matrix tablets.
It is particularly well-suited for formulations containing highly soluble APIs and preparations requiring strictly defined release profiles to prevent dose dumping.
Its key advantage is construction of a highly stable hydrophilic gel matrix, which enables the precise modulation of drug diffusion rates, effectively prevents burst release, and ensures a smooth, sustained release profile.
CELOPRE® MK30M is specifically designed for a high API content where standard HPMC struggles to maintain structural integrity.
This product is suitable for multi-layer tablets (bi-layer tablets), gradient release formulations, and combination controlled-release systems.
