TYLOPUR® 603
TYLOPUR® 603 is a versatile hypromellose, compliant with USP, JP, EP. It is a film coating material that provides an excellent finish. It is a effective binder, it does not interact with drugs. It also enhances the solubility of poorly solule APIs.
Properties
- Physical Form
- Powder
- Solid
- Pharma and Nutraceuticals Functions
- Binder
- Coating System
- Thickener
- Viscosity Modifier
Product families
Applications
- Excipients & Coatings
Product Families
- Binders & Disintegrants
- Formulation & Processing Aids
- Pharmaceutical Coatings
Other characteristics
- Brand
- TYLOPUR
- Functions
Binder, Coating System, Thickener, Viscosity Modifier
- Certifications & Compliance
European Pharmacopeia (Ph. Eur.), GMP, Japan Pharmacopeia (JP), United States Pharmacopeia (USP)
- Note
Harmonized items among the USP, EP and JP; Specific local attribute in EP; Viscosity is measured with 2 % aqueous solution at 20 °C. Viscosity ranges are 80 % – 120 % of the nominal value for samples with a viscosity less than 600 mPa.s and 75 % – 140 % of the nominal value for samples with 600 mPa.s or higher. Viscosity is hormonized item among the USP, EP and JP.
- Grade
- Pharma Grade
- Markets
- Healthcare & Pharma
- Appearance
- Conforms
- Technology
- Pharmaceuticals & Nutraceuticals
- Packaging Type
- Boxes
- Drums
- Storage Information
Keep dry. Store away from excess heat and sunlight.; Store preferentially in original packaging.
- Chemical Inventories
- AICS (Australia)
- DSL (Canada)
- EEC/EU
- EINECS (EU)
- ENCS (Japan)
- IECSC (China)
- KECI (Korea)
- NZIoC (New Zealand)
- Applications
Tablet/ pellet coating; Granulation binder; Suitable for film coating; Very suitable binder solution (wet granulation).; Very suitable pellets film coating; Very suitable solvent free methods (HME) for capsules; Very suitable solvent methods for capsules; Very suitable for dry syrup
- Packaging Information
Fiber drum (40-50 kg) with polyethylene single bag inside of 450 mm x h 740 mm(110 liters).
- Regulatory Information
- EU-Regulations
- National regulations
- Manufacturing Technology
- Direct Compression
- Dry Granulation
- Wet Granulation
- Certifications and Compliance
- European Pharmacopeia (Ph. Eur.)
- GMP
- Japan Pharmacopeia (JP)
- United States Pharmacopeia (USP)
- Key Quality Attributes in Matrix Tablets
- Decrease in initial erosion
- Faster drug release
- No effect on tablet hardness
Technical data
Table 1 of 1
9 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Viscosity | 3 - 15 | mPa.s | — |
| Viscosity | 4.0 - 6.0 | mPa.s | EP |
| Identification (A - E) | Conforms | — | EP |
| pH | 5.0 - 8.0 | — | EP |
| Loss on Drying | max. 5.0 | % | EP |
| Sulphated Ash/ Residue on Ignition | max. 1.5 | — | EP |
| Heavy Metals | max. 20 | ppm | EP |
| Methoxy Content | 28.0 - 30.0 | % | EP |
| Hydroxypropoxy Content | 7.0 - 12.0 | % | EP |
