CELOPRE® MK40M is a USP/NF pharmacopoeia-grade, low-methoxy, high-viscosity K-series HPMC (approx. 35,000–45,000 mPa·s), primarily used in sustained-release tablets and hydrophilic matrix systems to achieve the continuous and controlled release of drugs through the formation of a gel layer.
| Test Item | Unit | Specification | Method |
|---|---|---|---|
| Characters | Conforms | USP NF | |
| Identification A | Conforms | USP NF | |
| Identification B | Conforms | USP NF | |
| Identification C | Conforms | USP NF | |
| Identification D | Conforms | USP NF | |
| Identification E | Conforms | USP NF | |
| Identification F | Conforms | USP NF | |
| pH | 5.5-8.0 | USP NF | |
| Apparent Viscosity | mPa.s | 35,000 – 45,000 | USP NF |
| Appearance of Solution | Conforms | USP NF | |
| Chlorides | % | Max 0.5 | USP NF |
| Loss on drying | % | 5.0 Max | USP NF |
| Residue on ignition | % | 1.0 Max | USP NF |
| Heavy metals | % | Not more than 0.001 | 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 |
Remark: This product complies with the specifications described in the current pharmacopeia.
Pack in drums, net weight 25kg per drum.
Store in sealed container, keep away from sunlight & moisture.
CELOPRE® MK40M is used to regulate drug release by forming a gel barrier.
CELOPRE® MK40M is characterized by stable release and adjustable release profiles.
CELOPRE® MK40M is primarily utilized in high-dose API tablets and sustained-release formulations.
