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CERTIFICATE OF ANALYSIS
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Product Name |
Tetracycline hydrochloride |
Batch No. |
20211216 |
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MFG. Date |
16 Dec.2021 |
Exp. Date |
16 Dec.2023 |
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Report Date |
16 Dec.2021 |
Packages |
20 Fibre drum |
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|
Spec. |
25kgs/Fibre drum |
Standard |
BP2010 |
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ITEMS |
SPECIFICATIONS |
RESULTS |
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Characteristics |
Appearance：Yellow, crystalline powder |
Pass |
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Solubility：Complies with the specification |
Pass |
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Identification |
A, similar. B, C, Positive |
Pass |
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PH |
1.8~2.8 |
2.5 |
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Specific optical rotation |
-240°~255° |
-247° |
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Related substances |
4-epiteracycline HCI≤3.0% |
1.44% |
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Anhydrotetracyoline HCL≤0.5% |
0.19% |
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4-epianhydrotetracycline HCI≤0.5% |
0.02% |
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2-acetyl-2-decarbamoyitetracycline HCI≤1.5% |
0.69% |
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Heavy metals |
Complies with limit test（50ppm） |
pass |
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Loss on drying |
Not more than 2.0% |
0.21% |
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Sulphated ash |
Not more than 0.5% |
0.07% |
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Assay(on dry) |
95.0% to 100.5% |
97.3% |
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Conclusion |
It complies with BP2010 |
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