Tylosin Tartrate Antimicrobial Resistance Profiling Cas 1405-54-5

Product Name

Tylosin Tartrate

Apply for

Product Department

Specification

15kg/carton

Batch No.

JT202312008

Report No.

CP202312411

Quantity

2100.00kg

Manufacturing Date

2023.12.16

Expiry Date

2025.12.15

Inspection Date

2023.12.17

Reporting Date

2023.12.19

Testing Criteria

< EP 9.0 >

Testing Items

Specification

Test Result

Description

Almost white or slightly yellow, hygroscopic powder.

Complies

Solubility

It is easily soluble in water and dichloromethane, slightly

soluble in anhydrous ethanol, and soluble in dilute solution of inorganic acid.

Complies

Identification

The IR absorption spectrum of this product should be consistent with the control spectrum.

Complies

The retention time of Tylosin A peak of the test solution shall

be the same as that of the standard solution.

Complies

It should be the positive reaction.

Complies

Acidity

pH value should be5.0～7.2.

6.2

Tyramine

The content should be less than 0.35%. If the product is used to produce parenteral preparations, the content should be less

than 0.15%.

0.052%

Loss on drying

Not more than 4.5%.

1.7%

Residue on ignition

Not more than 2.5%.

0.34%

Tylosin A

Tylosin A≥80%.

94%

Total components

Tylosin A+B+C+D≥ 95%.

98%

Potency

The potency of 1 milligram sample is not less than

800U of tylosin on the dried basis.

940

The product meets all requirements of EP 9.0.