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氯霉素 COA/56-75-7

CERTIFICATE OF ANALYSIS

 

Product Name

Chloramphenicol

Batch No.

20190805

MFG. Date

Aug 05,2019

Exp. Date

Aug 04,2021

Quantity

250kg

Batch size

25kg

Test Items

Specifications

Results

Characteristics

Fine white or grayish white or yellowish white needle-like crystals or elongated plates

Yellowish whie needle-like crystals or elongated plates

Identification

Positive

Positive

Melting Point

149~153oC

150.0-152.3oC

Assay

98.5~102%

99.6%

Loss on drying

≤0.5%

0.18%

Residue on Ignition

≤0.10%

0.06%

Acidity or Alkalinity(PH)

5.0~7.5

5.30

Specific Rotation

+18.5~+20.5o

+19.1o

Heavy Metals

≤0.001%

≤0.001%

Related Substances

The any secondary spot≤0.5% Total≤2.0%

The any secondary spot≤0.5% Total≤2.0%

Chloride

≤0.005%

≤0.005%

Crystallinity

Meets the requirements

Meets the requirements

Conclusion

The above product complies with the standard EP9.0/BP2013/USP36.

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