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Certificate of Analysis
LOW SUBSTITUTED HYDROXYPROPYL CELLULOSE
|
BATCHNUMBER |
20090404 |
TEST DATE |
|
|
QUANTITY |
sample |
MANUFACTURE DATE |
|
|
PACKING |
|
EXPIRATIONDATE |
|
TEST |
SPECIFICATION |
RESULT |
Appearance |
White or off-white powder, no visible evidence of contamination by foreign matter |
Conforms |
|
Identification |
Conform |
Conforms |
|
Particle size |
100%through 100 mesh sieve |
Conforms |
|
PH |
5.0 — 7.5 |
PH 6.2 |
|
Chloride |
Not More Than 0.355% |
< 0.355 % |
|
Iron |
Not More Than 0.01 % |
< 0.01 % |
|
Loss on drying |
Not More Than 5.0% |
1.9 % |
|
Residue on ignition |
Not More Than 0.5% |
0.2% |
|
Heavy Metal |
Not More Than 0.001% |
< 0.001 % |
|
Arsenic |
Not More Than 0.0002% |
< 0.0002 % |
|
Assay |
7.0% to 16.0% of C3H7O2 Calculated on the anhydrous basis |
10.4 % |
|
Bioburden |
|
|
|
Total Microbial Count |
Not More Than 1000CFU/gram |
Conforms |
|
Total Mold and Yeast |
Not More Than 100CFU/gram |
Conforms |
|
Escherichia Coli |
Negative |
Not Detect |
Analysts: Checker: Supervisor:
FINAL BATCH DISPOSITION
By:
Approved Rejected
Manufactured By: Huzhou Zhanwang Pharmaceutical Co. Ltd
Certificate of Analysis
ls-Hydroxypropyl cellulose USP28
|
BATCHNUMBER |
20070406 |
TEST DATE |
|
|
QUANTITY |
sample |
MANUFACTURE DATE |
|
|
PACKING |
|
EXPIRATIONDATE |
|
TEST |
SPECIFICATION |
RESULT |
Appearance |
White or off-white powder, no visible evidence of contamination by foreign matter |
Conforms |
|
Identification |
Conform |
Conforms |
|
Particle size |
100%through 100 mesh sieve |
Conforms |
|
PH |
5.0 — 7.5 |
PH 6.9 |
|
Chloride |
Not More Than 0.355% |
< 0.355 % |
|
Iron |
Not More Than 0.01 % |
< 0.01 % |
|
Loss on drying |
Not More Than 5.0% |
4.3 % |
|
Residue on ignition |
Not More Than 0.5% |
0.2% |
|
Heavy Metal |
Not More Than 0.001% |
< 0.001 % |
|
Arsenic |
Not More Than 0.0002% |
< 0.0002 % |
|
Assay |
7.0% to 16.0% of C3H7O2 Calculated on the anhydrous basis |
8.9 % |
|
Bioburden |
|
|
|
Total Microbial Count |
Not More Than 1000CFU/gram |
Conforms |
|
Total Mold and Yeast |
Not More Than 100CFU/gram |
Conforms |
|
Escherichia Coli |
Negative |
Not Detect |
Analysts: Checker: Supervisor:
FINAL BATCH DISPOSITION
By:
Approved Rejected
Manufactured By: Huzhou Zhanwang Pharmaceutical Co. Ltd