Knowde Enhanced TDS
Identification & Functionality
- Chemical Name
- Pharma & Nutraceuticals Functions
- CAS No.
- 9004-65-3
- EC No.
- 618-389-6
- Technologies
- Product Families
- Structure
Features & Benefits
- HPMC Key Quality Attributes in Matrix Tablets
- Decrease in initial erosion
- Faster drug release
- No effect on tablet hardness
Applications & Uses
- Markets
- Applications
- Manufacturing Technology
- Product Applications
- Tablet/ pellet film coating
- Granulation binder
- Suitable for capsule shell
- Suitable for dry syrup
- Suitable for oral strips
Properties
- Appearance
- Conforms
- Typical Properties
- 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.
| Value | Units | Test Method / Conditions | |
| Heavy Metals | max. 20 | ppm | EP |
| Viscosity | 3 - 15 | mPa.s | — |
| Viscosity | 4.0 - 6.0 | mPa.s | EP |
| HPMC | 6.75 | %w/w | — |
| Hydroxypropoxy Content | 7.0 - 12.0 | % | EP |
| Loss on Drying | max. 5.0 | % | EP |
| Talc | 2.85 | %w/w | — |
| Methoxy Content | 28.0 - 30.0 | % | EP |
| TiO₂ | 3.9 | %w/w | — |
| pH | 5.0 - 8.0 | — | EP |
| Pigment | 0.15 | %w/w | — |
| PEG 6000 | 1.35 | %w/w | — |
| Water | 85 | %w/w | — |
| Solid Content | 15 | %w/w | — |
| Nozzle Type | Schlick 970 | — | — |
| Nozzle Pressure | 0.65 | bar | — |
| Inlet Air Flow (Coating Parameters) | constant | m³/h | — |
| Inlet Air Flow (Coating Parameters) | 80 | °C | — |
| Tablet bed temperature pre-heating (Coating Parameters) | 40 | °C | — |
| Tablet bed temperature during coating | 38 - 40 | °C | — |
| Spray Rate (coating parameters) | 4.5 - 6.4 | g/min | — |
| Pan speed (Coating Parameters) | 22 | rpm | — |
| Weight | 258.8 | mg | — |
| Disintegration time | 559 | sec | — |
| Dissolution (>80 %) | 10 | min | — |
| Identification (A - E) | Conforms | — | EP |
| Sulphated Ash/ Residue on Ignition | max. 1.5 | — | EP |
Regulatory & Compliance
- Certifications & Compliance
- Chemical Inventories
- Grade
- Regulatory Information
- EU-Regulations
- No REACH Annex XVII restrictions. This product is not on the REACH Candidate List
- This product is not on the REACH Annex XIV List
- This product Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH) with its amendment Regulation (EU) 2020/878 SDS No: 10896-0310 16/03/2021 (Revision date) GB - en 8/9
- This product is not subject to Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 july 2012 concerning the export and import of hazardous chemicals. This product is not subject to Regulation (EU) No 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants
- Contains no substance subject to Regulation (EU) 2019/1148 of the European Parliament and of the Council of 20 June 2019 on the marketing and use of explosives precursors.
- National regulations
- Listed on the United States TSCA (Toxic Substances Control Act) inventory
- Listed on the Canadian DSL (Domestic Substances List)
- Listed introduction on Australian Industrial Chemicals Introduction Scheme (AICIS Inventory)
- Listed on the EEC inventory EINECS (European Inventory of Existing Commercial Chemical Substances)- Directive 79/831/EEC, sixth Amendment of Directive 67/548/EEC (dangerous substances)
- Listed on the Japanese ENCS (Existing & New Chemical Substances) inventory Listed on PICCS (Philippines Inventory of Chemicals and Chemical Substances)
- Listed on NZIoC (New Zealand Inventory of Chemicals)
- Listed on the TCSI (Taiwan Chemical Substance Inventory) Listed on IECSC (Inventory of Existing Chemical Substances Produced or Imported in China) Listed on KECL/KECI (Korean Existing Chemicals Inventory)
Packaging & Availability
- Packaging Information
Fiber drum (40-50 kg) with polyethylene single bag inside of 450 mm x h 740 mm(110 liters).
Storage & Handling
- Storage Information
- Keep dry. Store away from excess heat and sunlight.
- Store preferentially in original packaging.