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|
PRODUCT |
PREDNISOLONE SODIUM PHOSPHATE |
DATE OF SAMPLEING |
OCT.28.2019 |
|
BATCH NUMBER |
20191005 |
DATE OF RELEASE |
NOV.7.2019 |
|
BATCH SIZE |
80.30KG |
RETEST DATE |
SEP.2022 |
|
TEST ITEM |
SPECIFICATION |
RESULT |
|
APPEARANCE |
WHITE OR ALMOST WHITE CRYSTALLINE POWDER |
WHITE CRYSTALLINE POWDER |
|
IDENTIFICATION |
B(2.2.24) |
CONFORM |
CONFORM |
|
|
C(2.2.27) |
CONFORM |
CONFORM |
|
APPEARANCE OF SOLUTION |
SOLUTION IS CLEAR AND NOT MORE INTENSELY COLOURED THAN REFERENCE SOLUTION B7 |
QUALIFIED |
|
PH |
7.5-9.0 |
8.4 |
|
SPECIFIC OPTICAL ROTATION |
+94°~+100° |
+99° |
|
RELATED SUBSTANCES |
ANY PEAK≤2.0% ONLY ONE PEAK＞1.0% TOTAL≤3.0% |
THE MAX:0.31% TOTAL:1.4% |
|
INORGANIC PHOSPHATE |
≤1% |
＜1.0% |
|
WATER |
≤8.0% |
5.2% |
|
ASSAY |
96.0~103.0% (ON ORIED SUBSTANCE) |
98.6% |
|
CONCLUSION:CONFORMS TO EP8.0 |
|
RESIDUAL SOLVENTS |
METHANOL＜1500PPM ACETONE＜5000PPM ETHYL ACETATE＜1500PPM TETRAHYDROFURAN＜720PPM METHYL ISOBUTYKETONE＜1500PPM |
628PPM 2377PPM NOT DETECTED NOT DETECTED NOT DETECTED |
|
MICRONIZED |
|
STORAGE:STORE IN AN AIRTIGHT CONTAINER PROTECTED FORM LIGHT |
