FINCELO® MC/HPMC for PHARMACEUTICAL
FINCELO MC/HPMC series products are non-ionic cellulose ether products. They are widely used as thickeners, binders, film-formers and water-retention for pharmaceutical industry.
PRODUCT DESCRIPTION
Chemical Name：Methyl cellulose (MC)
Molecular Formula：[C6H7O2(OH)3 -n(OCH3) n]x
Structure Formula：
Where：R=-H, or -CH3；X=degree of polymerization
Chemical Name：Hydroxypropylmethyl cellulose (HPMC)
Molecular Formula：[C6H7O2(OH)3-m-n(OCH3)m(OCH3CH(OH)CH3)n]x
Structure Formula：
Where：R=-H, -CH3, or -CH2CHOHCH3；X=degree of polymerization
PRODUCT CAS NUMBER
MC: 9004-67-5
HPMC: 9004-65-3
SPECIFICATIONS
Items | Specifications | ||||
| MC | HPMC | ||||
| MA | MF | MG | MJ | MK | |
| Methoxyl group content, % | 27.5~31.5 | 27.0~30.0 | 28.0~30.0 | 16.5~20.0 | 19.0~24.0 |
| Hydroxypropyoxyl content, % | - | 4.0~7.5 | 7.5~12.0 | 23.0~32.0 | 4.0~12.0 |
| Appearance | White to off-white powder | ||||
| Identity Test A to E | Positive | ||||
| Loss on drying,% | Max 5.0 | ||||
| Residue on ignition,% | Max 1.5 | ||||
| Heavy metals, ppm | Max 20 | ||||
| Arsenic, ppm | Max 3.0 | ||||
| PH | 5.0~8.0 | ||||
| Viscosity, mPa.s | See below table | ||||
| Grade | Viscosity range*, mPa.s | Grade | Viscosity range*, mPa.s |
| 5 | 4~6 | 4M | 3000~5600 |
| 15 | 12~18 | 8M | 6000~9000 |
| 25 | 20~30 | 10M | 9000~12000 |
| 50 | 40~60 | 15M | 12000~18000 |
| 1C | 80~120 | 20M | 18000~30000 |
| 4C | 300~500 | 40M | 30000~50000 |
| 8C | 600~900 | 50M | 85000~130000 |
| 15C | 1000~2000 | 70M | Min 180000 |
| *Ubbelohde viscosity meter at20 °C in a 2% aqueous solution | |||
APPLICATION
FINCELO MC/HPMC conforms to China Pharmacopoeia, U.S. Pharmacopoeia and European Pharmacopoeia.
They are multipurpose additive for pharmaceutical, can be functioned as thickener, dispersant, emulsifier, film forming agent, etc.
They are used in tablets for dressing and binding to improve solubility of the drugs and reinforce tablets’ water prevention function.
They can also be utilized as mixed suspending agent, additive for eye drops, sustained-release agent, and so on.
| Pharmaceutical application | Recommended type | Typical use level |
| Bulk Laxative | MA-4M,MK-4M,MK-1C,MK-50M | 3-30% |
| Creams, Gels, and Ointments | MA-4M, MG-4M, MF-4M, MK-4M | 1-5% |
| Ophthalmic Preparations | MG-4M | 0.1-0.5% |
| Eye drops preparations | MA-4M, MF-4M, MK-4M | 0.1-0.5% |
| Suspending agent | MA-4M, MG-4M, MK-4M | 1-2% |
| Antacids | MA-15C,MA-4M, MG-4M, MK4M, MK-15M, MF-4M | 1-2% |
| Tablets binder | MA-15, MG-5, MF-50, MK-1C | 0.5-5% |
| Conventional Tablet Coating | MG-5, MG-15 | 0.5-5% |
| Conventional Wet Granulation | MG-5, MG-15 | 2-6% |
| Controlled Release Coatings | MG-5, MG-15 | 3-20% |
| Tablet coatings | MG-5, MG-15, MG-50 | 0.5-5% |
| Controlled Release Matrix Tablets | MK-50M, MK-15M, MK-4M, MG-4M | 20-55% |
| Vegetable Capsules | MG-5 | 5 -20% |
PRODUCT SAFETY
Please refer to Safety Data Sheet (SDS) before using this product.
PACKAGING AND STORAGE
FINCELO® MC/HPMC use 25KG compound paper bag or 25KG composite fiberboard drum with inner PE film.
FINCELO MC/HPMC are non-perishable product. It is recommended to use the product in rotation on a first-in first-out basis. The product should be stored under dry and clean conditions in original packing and away from heat and moisture.