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Microcrystalline Cellulose Spheres
CAS: 9004-34-6
Character: White or kind of white near circular pellets，composed by Microcrystalline Cellulose, can be used as cores for the manufacture of sustained & controlled-release pellets for both western and Chinese traditional medicines.
Package: Net weight 25KG per drum with two inner plastic bag packing.
Specifications: Conforms to standard YBH 、USP30.
|
standard
Items |
YBH |
USP30 |
Identification |
A. Coloration reaction: Should present the response |
A. Coloration reaction: Should present the response |
PH |
5.0～7.5 |
5.0～7.5 |
|
Soluble substances in Water |
≤0.2% |
≤0.2%
|
|
size |
Upper limit shall not exceed 10%,
Lower limit shall not exceed 10% |
The specification which above the ceiling must 100% through，
Upper limit shall not exceed 10%,
Lower limit shall not exceed 10% |
|
Heavy metals |
≤10 ppm |
≤10 ppm |
|
Loss on drying |
≤5.0% |
≤5.0%
|
Chloride |
≤0.03% |
≤0.03% |
Starch |
No blue color is produced |
No blue color is produced
|
Hoevillite |
≤0.0002％ |
≤0.0002％ |
|
Residue on ignition |
≤0.2% |
≤0.2%
|
|
Microbial limit |
E..coli shouldn’t be detected,
Total Aerobic Plate Count ≤1000cfu/g
Mold and yeast≤100 cfu/g
|
E..coli、Salmonella species、Staphylococcus aureu、Pseudomonas aeruginosa shouldn’t be detected,
Total aerobic microbial count ≤100cfu/g
Mold and yeast≤50 cfu/g
|
|
Microcrystalline Cellulose content |
97.0%~102.0% |
97.0%~102.0%
|