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Certificate of Analysis
Hydroxypropyl Methylcellulose 2910 USP30 (E-5)
|
BATCHNUMBER |
201104003 |
TEST DATE |
|
|
QUANTITY |
Sample |
MANUFACTURE DATE |
|
|
PACKING |
|
EXPIRATIONDATE |
04-01-2014 |
TEST |
SPECIFICATION |
RESULT |
Appearance |
White or off-white powder, no visible evidence of contamination by foreign matter |
conforms |
|
Identification |
Conform |
conforms |
|
PH |
5.5 — 7.5 |
PH 6.2 |
|
Viscoisty |
4.0 —6.0 cp.s |
4.6cp.s |
|
Water-insoluble Substances |
Not More Than 0.5% |
0.2 % |
|
Loss on drying |
Not More Than 5.0% |
2.0 % |
|
Residue on ignition |
Not More Than 1.5% |
0.4 % |
|
Heavy Metal |
Not More Than 0.001% |
< 0.001 % |
|
Arsenic |
Not More Than 0.0002% |
< 0.0002 % |
|
Whiteness |
Min 80 |
83.6 |
|
Methoxy |
28.0% to 30.0% CH3O Calculated on the anhydrous basis |
28.1 % |
|
Hydroxypropoxy |
7.0% to 12.0% C3H7O2 Calculated on the anhydrous basis |
7.4% |
|
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
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