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June 15, 2021
Test items
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Specifications
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Results
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Test methods
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Characters
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The total combined yeasts/mould count
|
Complies
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Visual method
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Identification1
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UV: The absorption spectrum exhibits maxima at 264nm,285nm,305nm and 460nm.
|
Complies
|
ChP 2015
|
Identification2
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HPLC:The retention time of the major peak of the sample solution corresponds to that of the reference solution.
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Complies
|
ChP 2015 monograph
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Identification3
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The IR spectra of the sample is similar with the reference spectra
|
Complies
|
ChP 2015 monograph
|
Loss on drying
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W10.0%
|
9.4%
|
ChP 2015
|
Assay
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98.5% -102.0%
|
100.0%
|
ChP 2015
|
Hydroxocobalamine
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UV: A460nm/A352nmN0 90
|
0.957
|
ChP 2015
|
Related substances
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The sum of each impurity peak area is not larger than 1.0% of the main area of the reference solution
|
1.0%
|
ChP 2015 monograph
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Acetone
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W0.5%
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0.004%
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In house/(GC)
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The total aerobic microbial count
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W1000 cfu/g
|
2.9x102cfu/g
|
ChP 2015 |
The total combined yeasts/mould count
|
W1000 cfu/g
|
10cfu/g
|
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