TYLOPUR® 65SH-400
TYLOPUR® 65SH-400 is a versatile hypromellose, compliant with USP, JP, EP. The low viscosity grades are especially suitable for the design of film-coated tablet formulations.TYLOPUR® 65SH-400 is effective as a binder, since it does not interact with drugs. It has superior stability, a non-ionic character and is widely used as a binder for granulation. Due to its plant derived nature and excellent moisture stability, TYLOPUR® replaces gelatin in hard capsule manufacturing.
Properties
- Physical Form
- Powder
- Solid
- Pharma and Nutraceuticals Functions
- Binder
- Controlled Release Agent
- Sustained Release Agent
- Thickener
- Viscosity Modifier
Product families
Applications
- Oral
- Excipients & Coatings
Product Families
- Binders & Disintegrants
- Formulation & Processing Aids
- Modified & Controlled Release
Other characteristics
- Brand
- TYLOPUR
- Functions
Binder, Controlled Release Agent, Sustained Release Agent, Thickener, Viscosity Modifier
- Dosage Form
- Suspension, Tablets
- Suspension
- Tablets
- Certifications & Compliance
European Pharmacopeia (Ph. Eur.), GMP, Japan Pharmacopeia (JP), United States Pharmacopeia (USP)
- 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
- Suitable for thickening
- Suitable for suspending
- Liquid and semi-solid
- Suitable for sustained release
- Packaging Information
Fiber drum (40-50 kg) with polyethylene single bag inside of 450 mm x h 740 mm (110 liters).; Big bag of 1060 x w 710 x h 1250 mm (up to 1040 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.
- Slower drug release.
- No effect on tablet hardness.
Technical data
Table 1 of 1
9 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Viscosity | 320 - 480 | mPa.s | — |
| Viscosity | 50 - 4000 | mPa.s | — |
| 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 | — | EP |
| Heavy Metals | max. 20 | ppm | EP |
| Methoxy Content | 27.0 - 30.0 | % | — |
| Hydroxypropoxy Content | 4.0 - 7.5 | — | — |
