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喜樹堿 黃體酮 噻菌靈/噻苯咪唑 硫酸新霉素 紅霉素
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
C(2.2.27)
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
MICRONIZED
STORAGE:STORE IN AN AIRTIGHT CONTAINER PROTECTED FORM LIGHT
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