|
NAME |
DL(+)-MALIC ACID
(pharmaceutical excipients) |
BATCH NO. |
HY01453 |
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|
MANUFACTURE DATE |
JUN 08，2020 |
QUANTITY |
19MT |
||
|
EXPIRY DATE |
JUN 07，2022 |
TEST DATE |
JUN 08，2020 |
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|
ITEM |
STANDARD |
RESULT |
|||
|
ASSAY,W/% |
>99.0 |
99.9 |
|||
|
MELTIONG POINT |
128-132 |
130 |
|||
|
SPECIFIC ROTATION[a]D |
-0.1-+0.1 |
0.09 |
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|
CLARITY AND COLOR: |
CLEAR AND COLORLESS |
CONFIRMED |
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|
INSOLUBLE MATTER IN WATER |
≤0.1% |
0.08% |
|||
|
RELATED SUBSTANCES |
FUMARIC ACID: |
≤1.0% |
1.0% |
||
|
MALEIC ACID |
≤0.05% |
0.02% |
|||
|
OTHER LARGEST SINGLE HYBRID |
≤1.0% |
1.0% |
|||
|
OTHER GENERAL MISCEL LANEOUS: |
≤0.5% |
0.03% |
|||
|
CHLORIDE[CI]: |
≤0.005% |
0.005% |
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|
SULFATE[SO4]: |
≤0.03% |
<0.03% |
|||
|
WATER : |
≤2.0% |
1.8% |
|||
|
BURNING RESIDUE: |
≤0.1% |
0.09% |
|||
|
CALCIUM SALT: |
≤0.02% |
0.01% |
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|
HEAVY METALS(IN PB): |
≤20μg/g |
<20μg/g |
|||
|
ARSENIC(AS): |
≤2μg/g |
<2μg/g |
|||
|
TOTAL AEROBIC BACTERIA: |
≤1000cfu/g |
900cfu/g |
|||
|
|
≤100cfu/g |
99cfu/g |
|||
|
ESCHERICHIA COLI: |
NO DETECTION |
CONFIRMED |
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