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Sugar Sphere
CAS: 92004-84-7
Character: White or kind of white near circular pellets，composed by sucrose and starch, 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 Q/WS,EP, BP,USP.
|
standard
Items |
Q/WS |
EP5.2 |
BP2003 |
USP29-NF24 |
|
Identification |
A. Boil identification
B. Iodize identification |
A. Thin layer chromatography (TLC)
B. starch check
C. sucrose inspection |
A. thin layer chromatography (TLC)
B. starch check
C. sucrose inspection |
starch check |
|
Specific rotation |
+41º~ +61º |
+41º~ +61º |
+41º~ +61º |
+41º~ +61º |
|
size |
Upper limit shall not exceed 10%,
Lower limit shall not exceed 10% |
Bound should not be less than 90% |
Bound should not be less than 90% |
The specification which above the ceiling must 100% through，
Upper limit shall not exceed 10%,
Lower limit shall not exceed 10% |
|
Heavy metals |
5 ppm |
5 ppm |
5 ppm |
5 ppm |
|
Loss on drying |
≤4.0% |
≤5.0% |
≤5.0% |
≤4.0% |
|
Residue on ignition |
≤0.25% |
≤0.2% |
≤0.2% |
≤0.25% |
|
Microbial limit |
Salmonella species shouldn’t be detected,
Total aerobic microbial count ≤100cfu/g
|
Aerobes≤1000cfu/g,
Fungi ≤100cfu/g,
Salmonella species and E..coli shouldn’t be detected |
Aerobes≤1000cfu/g,
Fungi ≤100cfu/g,
Salmonella species and E..coli shouldn’t detected |
Total aerobic microbial count≤100cfu/g.
Salmonella species、 E..coli、Staphylococcus aureus、Pseudomonas aeruginosa shouldn’t be detected |
|
Sucrose content |
62.5%~91.5% |
＜92% |
＜92% |
62.5% ~91.5% |