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WUHAN DONG KANGYUAN TECHNOLOGY CO.,LTD 
CERTIFICATE OF ANALYSIS
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Product name |
BUDESONIDE |
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|
Batch No. |
201011 |
Quantity |
120g |
|
Mfg. Date |
Oct.,11, 2020 |
Expiry date |
Oct.,11, 2022 |
|
Specification |
EP6 |
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|
Items |
Standard |
Results |
|
Characters |
A white or almost white crystalline powder, practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in alcohol. |
white crystalline powder
Complies |
|
Identification (A:IR) |
Complies with the Standard |
Complies |
|
Related Substances |
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-any impurity |
Not more than 0.5% |
0.22% |
|
-sum impurities |
Not more than 1.5% |
0.44% |
|
Epimer A |
40.0%～51.0% |
42.0% |
|
Methanol |
Not more than 0.1% |
Complies |
|
Loss on drying |
Not more than 0.5% |
0.02% |
|
Assay(HPLC, basis on drying) |
98.0%～102.0% |
99.6% |
|
Organic volatile substances |
Meet the ICH requirements |
Complies |
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Packaging and storage: Preserve in tight, light-resistant containers. Conclusion: The test product complies with the requirements of EP6. |
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