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TYLOPUR® 645
TYLOPUR® 645 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
- Thickener
- Viscosity Modifier
Product families
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
- Oral
Healthcare & Pharma — Pharmaceutical Manufacturing
- Excipients & Coatings
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
- Binders & Disintegrants
- Formulation & Processing Aids
Other characteristics
- Brand
- TYLOPUR
- Functions
- Binder, Thickener, Viscosity Modifier
- Dosage Form
Capsules, Orally Disintegrating Films (ODFs), Pellets, Tablets; Capsules; Orally Disintegrating Films (ODFs); Pellets; Tablets
- Labeling Claims
Allergen-free, Halal, Kosher, Non-GMO, Plant-Based; Allergen-free; Halal; Kosher; Non-GMO; Plant-Based
- Certifications & Compliance
EU Compliant, EXCiPACT, European Pharmacopeia (Ph. Eur.), FCC Compliant, FDA Compliant, FSSC 22000, GMP, Generally Recognized As Safe (GRAS), Halal, ISO 14001, ISO 9001, Japan Pharmacopeia (JP), Kosher, United States Pharmacopeia (USP)
- Grade
- Pharma Grade
- Markets
- Healthcare & Pharma
- Technology
- Pharmaceuticals & Nutraceuticals
- Packaging Type
- Bags
- Boxes
- Chemical Inventories
- AICS (Australia)
- DSL (Canada)
- ENCS (Japan)
- KECI (Korea)
- NZIoC (New Zealand)
- PICCS (Phillipines)
- TCSI (Taiwan)
- TSCA (USA)
- Manufacturing Technology
- Tablet Coating
- Certifications and Compliance
- EU Compliant
- EXCiPACT
- European Pharmacopeia (Ph. Eur.)
- FCC Compliant
- FDA Compliant
- FSSC 22000
- GMP
- Generally Recognized As Safe (GRAS)
Technical data
Table 1 of 3
7 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Heavy Metals | max. 20 | ppm | — |
| Hydroxypropoxy Content | 7.0 - 12.0 | % | — |
| Loss on Drying | max. 5.0 | % | — |
| Methoxy Content | 28.0 - 30.0 | % | — |
| pH | 5.0 - 8.0 | — | EP |
| Sulphated Ash /Residue On Ignition | max. 1.5 | % | EP |
| Visocity | 3.6 - 5.1 | mPas | — |
Table 2 of 3
12 rows| Characteristic | Value | Unit |
|---|---|---|
| Inlet Air Flow (Coating Parameters) | Constant | m3/h |
| Inlet Air Flow (Coating Parameters) | 400.0 | m3/h |
| Inlet Air Temperature (Coating Parameters) | 80.0 | ⁰C |
| Nozzle Pressure Bar (Coating Parameters) | 0.65 | bar |
| Nozzle Pressure Bar (Coating Parameters) | 2.9 | bar |
| Pan Speed (Coating Parameters) | 22.0 | rpm |
| Pan Speed (Coating Parameters) | 5 (during 5min) - 12 | rpm |
| Spray Rate (Coating Parameters) | 4.2 - 5.9 | g/min |
| Spray Rate (Coating Parameters) | 6 - 23 | g/min |
| Tablet Bed Temperature during Coating | 38 - 40 | ⁰C |
| Tablet Bed Temperature during Coating | 35 - 40 | ⁰C |
| Tablet Bed Temperature during Coating | 40.0 | ⁰C |
Table 3 of 3
2 rows| Characteristic | Value | Unit |
|---|---|---|
| Disintegration Time | 474.0 | S |
| Dissolution(>80%) min | 10.0 | — |
