Microcrystalline cellulose SANCEL®–102
Name: Microcrystalline cellulose (PSANCEL®–102)
Chemical Structure:
Manufacturer: SIGACHI INDUSTRIES PVT. LTD.
Address: Dach, India
The company has passed ISO 9001 and 2008 cGMP DMF - US FDA certification. Microcrystalline cellulose SANCEL ®–102 is one of its leading products.
Main features of the product:
1. Unique production process: This product uses high-purity special wood pulp to produce cellulose polymer by acid hydrolysis and strict control of polymerization degree and spray drying.
2. High purity, good reproducibility and good stability
3. Spherical particles with large specific surface area, porous and uniform morphology, good adsorption and fluidity
4, the pressure is very strong, not easy to stratify, with excellent disintegration performance and good lubrication performance
5, can optimize the formula to improve production efficiency
Main uses of the product:
1. In the production of tablets, it can be used for direct dry pressing, which not only reduces energy consumption, shortens the production process, but also improves production efficiency and product quality;
2. Appropriate addition of microcrystalline cellulose 102 in tablet production can significantly increase the hardness of the tablet, accelerate the disintegration of the tablet, improve the dissolution of the drug, and increase the stability of the product;
3. Diluents and binders which are also useful in tablets and capsules;
4. In the food and pharmaceutical industries, microcrystalline cellulose 102 can also be used in adsorbents and suspending agents;
Quality Standard
project | Quality requirements |
Traits | Odorless and tasteless white or off-white powder |
Identification | meets the requirments |
Degree of polymerization | ≤350 |
Fineness,% | 60 mesh sieve residue ≤ 8 200 mesh sieve residue ≥ 45 |
Particle sizeD50,μm | 70-100 |
Bulk density,g/cm3 | 0.28-0.33 |
pHvalue | 5.0~7.0 |
chloride,% | ≤0.03 |
Lysate in water,% | ≤0.25 |
Conductivity,us/cm | ≤75 |
Residue on ignition,% | ≤0.10 |
Loss on drying,% | ≤5.0 |
Ether dissolution,% | ≤0.05 |
Heavy metal,ppm | ≤10 |
Microbial Limit |
|
bacterial,cfu/g | ≤1000 |
Mold,cfu/g | ≤100 |
Coliform | not detected |
Pathogenic bacteria |
Not checked out |
Containing cellulose on a dry basis,% | 97-102 |
Packing specification
The outer woven bag is lined with a high-pressure polyethylene film, 25 kg/bag, which can also be packaged according to customer agreement.
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