HPMCP HP-50
HPMCP is a monophthalic acid ester of hypromellose.HP-50 is enteric coating agent soluble at lower pH
Properties
- Physical Form
- Granules
- Powder
- Solid
- Pharma and Nutraceuticals Functions
- Coating System
- Controlled Release Agent
- Extended Release Agent
- Taste Masker
Product families
Applications
- Oral
- Excipients & Coatings
Product Families
- Flavors & Taste Maskers
- Modified & Controlled Release
- Pharmaceutical Coatings
Other characteristics
- Brand
- HPMCP
- Functions
Coating System, Controlled Release Agent, Extended Release Agent, Taste Masker
- Dosage Form
- Capsules, Pellets, Tablets
- Capsules
- Pellets
- Tablets
- Labeling Claims
Allergen-free, BSE-free, Kosher, Non-GMO, TSE-free; Allergen-free; BSE-free; Kosher; Non-GMO; TSE-free
- Certifications & Compliance
DMF Type IV, European Pharmacopeia (Ph. Eur.), GMP, Japan Pharmacopeia (JP), Kosher, National Formulary (NF), The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA), United States Pharmacopeia (USP)
- Note
*Viscosity of 10 w/w% solution of methanol and dichloromethane at 20°C
- Grade
- Pharma Grade
- Markets
- Healthcare & Pharma
- PACKAGE
25 kg - Fiber drum with polyethylene double bag inside; 1 kg - Polyethylene double bag
- Storage
Keep dry. Store away from excess heat and sunlight. Store in sealed containers.
- Features
Suitable for solvent coating system. As co-solvents, mixture of ethanol and water (80/20 w/w%) or mixture of acetone and water (95/5 w/w%) are recommendable.; Relatively stable, due to less hydrolysis.; Available as a solid dispersion carrier for solubility enhancement.
- Application
HPMCP is Very Suitable for Taste Masking; HPMCP is Very Suitable for Enteric/delayed release coating (solvent); HPMCP is Suitable for Solvent free methods; HPMCP is Very Suitable for Solvent methods; Tablet Coating; Granule Coating
- Technology
- Pharmaceuticals & Nutraceuticals
- Packaging Type
- Bags
- Drums
- Chemical Inventories
- AICS (Australia)
- ENCS (Japan)
- IECSC (China)
- KECI (Korea)
- PICCS (Phillipines)
- TCSI (Taiwan)
- TSCA (USA)
- Manufacturing Technology
- Tablet Coating
- Certifications and Compliance
DMF Type IV; European Pharmacopeia (Ph. Eur.); GMP; Japan Pharmacopeia (JP); Kosher; National Formulary (NF); The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA); United States Pharmacopeia (USP)
- Solubility in Various Organic Solvents
○ : soluble, △ : swollen or partially soluble × : insoluble, * : mixing ratio by weight
Technical data
Table 1 of 2
13 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Chloride | max. 0.07 | % | USP/NF |
| Dissolving pH | min. 5.0 | — | — |
| Free phthalic Acid | max. 1.0 | % | USP/NF |
| Heavy Metals | max. 0.001 | % | USP/NF |
| Hydroxy propoxy Content | 6.0 - 10.0 | % | USP/NF |
| Labeled Viscosity | 55.0 | cSt | — |
| Methoxy Content | 20.0 - 24.0 | % | USP/NF |
| Nominal Phthalyl Content | 24.0 | % | — |
| phthalyl Content | 21.0 - 27.0 | % | USP/NF |
| Residue on ignition | max. 0.20 | % | USP/NF |
| Viscosity | 44 - 66 | cSt | USP/NF |
| Viscosity | 55.0 | mPa.S | — |
Solubility in Various Organic Solvents
12 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| — | HP-55 HP-55S | HP-50 | AS-MG |
| Acetone | ○ | △ | ○ |
| Acetone/water (95:5)* | ○ | ○ | ○ |
| Acetone/ethanol (1:1)* | ○ | ○ | ○ |
| Dichloromethane | △ | △ | △ |
| Dichloromethane/ethanol (1:1)* | ○ | ○ | ○ |
| Dioxane | ○ | ○ | ○ |
| Methanol | △ | △ | ○ |
| Isopropanol | △ | × | × |
| Ethanol | × | × | × |
| Ethanol/water (8:2)* | ○ | ○ | ○ |
| Ether | × | × | × |
