武汉东康源科技有限公司

Product Name

DOXYCYCLINE HYCLATE

Batch No

20231228

Test Date

Dec.28.2023

Packing Size

25kg

MFG. Date

Dec.28.2023

Quantity

5kg

Exp Date

Dec.27.2025

Test Items

Specification

Test Results

Appearance

Yellow crystalline powder

Correspond

Identification

A）t_R of HPLC test

Correspond

B）Sulphuric acid yellow color reaction

C）Chloride’s reaction

PH

2.0 to 3.0

2.5

optical rotation

-105°to -120°, calculated on the anhydrous, ethanol-free substance

-114°

Specific Absorbance

317

Light absorbing impurities

Not more than 0.07 at 490nm, calculated on the anhydrous, ethanol-free substance

0.02

Related substances

Metacycline

Not more than 2.0%

Conforms

6-epidoxycycline

Not more than 2.0%

Any individual impurities

Not more than 0.5%

Disregard limit

Not more than 0.1%

Ethanol

4.3 to 6.0%

4.7%

Heavy metals

Less than 50ppm

＜50ppm

Water

1.4% to 2.8%

2.2%

Sulphate ash

Not more than 0.4%

＜0.1%

Assay

95.0%～102.0% of C₂₂H₂₄N₂O₈, calculated on the anhydrous，ethanol-free substance

98.3%

Conclusion

The above product conforms to CPV2010.