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ESPHERES SIO2 (Silicon Dioxide Spheres)
Consist of SiO2 and mainly used as a core for drug loading of insoluble and instable drug. Also used in MUPS technology.
Definition:
- ESPHERES SIO2 contains not more than 75% of Silicon Dioxide, calculated on the dried basis
- Colloidal Silicon Dioxide Complying with Ph.Eur., USP/NF and JP
- Produced in accordance with cGMP
Composition:
- Colloidal Silicon Dioxide
Features:
- White Coloured, hard brittle
- Low friability/Solubility
- Free flowing spheres
- High standard
- Uniform sphere size
- Anti-caking agent
- Uniform & Consistent Loading
General and microbiological information:
| Loss on drying |
– NMT 10% |
| < 100 cfu/g; No Pathogens |
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| pH |
– 4 to 7.5 |
| Residue on ignition: |
– 52.5-87.5% |
Re-evaluation Date - 36 months from the date of manufacture.
Applications:
- Adapted for controlled release or Sustained release formulations to produce spherical granules or pellets which have the most suitable size and dissolution profile.
- Suitable for highly soluble active pharmaceutical ingredients.
Particle Size (U.S. Standard Sieve) and specifications:
Product |
12/14 |
14/16 |
16/18 |
18/20 |
20/25 |
25/30 |
30/35 |
35/40 |
40/60 |
| ESPHERES SIO2 |
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- All intermediates ESPHERES are available on request.
- Not less than 90% of it passes the coarser sieve size stated in the labeling available on request.
- Not more than 10% passes the finer sieve size stated in the labeling. All of it passes the next coarser sieve listed in test procedure.
For more details about ESPHERES™ products, please contact us at info@idealcures.co.in |
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