Product Name

Oxytetracycline

6153-64-6

Batch No.

20210405

Quantity

5500kg

Packing

25kg/Bag

MFG. Date

2021.04.05

Exp. Date

2023.04.04

Report Date

2021.04.05

Standard

BP 2005/EP 5

ITEMS

SPECIFICATIONS

RESULTS

Characteristics

A yellow, crystalline powder

Pass

Identification

Positive

Pass

Acidity PH

4.5 ~ 7.5

5.46

Specific optical rotation

-203° ~ -216°

 -208°

Absorbance（353nm）

290 ~ 310

304

Light-absorbing impurities

430nm  ≤0.25

0.14

490nm  ≤0.20

0.123

Heavy metals

≤50ppm

Pass

Sulphated ash

≤0.5%

0.18%

Water

6.0% ~ 9.0%

7.70%

Related substances

4-epioxytetracycline

≤0.5%

Pass

Tetracycline

≤2.0%

Pass

2-acetly-2-decarboxanidooxytetracycline

≤2.0%

Pass

Assay（on dry）

95.0% ~ 102.0%

96.1%

Conclusion

It complies with BP 2005/EP 5