Tetracycline Hydrochloride CAS 64-75-5

TESTS

SPECIFICATIONS

RESULTS

DESCRIPTION

Yellow, odorless, crystalline powder.

Yellow, odorless, crystalline powder

IDENTIFICATION

A The sample exhibits maxima only at the same wavelengths as that of a similar preparation of

Passes test

the standard in the infrared spectrum

B The retention time of the major peak of the

Passes test

sample solution corresponds to that of standard solution, as obtained in the Assay.

C Meets the requirements of the tests for Chloride.

Passes test

SPECIFIC ROTATION

-240° to -255°

-250°

CRYSTALLINITY

Meets with specification

Passes test

PH

1.8 to 2.8

2.5

LOSS ON DRYING

Not more than 2.0%

0.4%

RELATED SUBSTANCES (HPLC)

4-EPITETRACYCLINE

Not more than 3.0%

1.05%

4-EPIANHYDROTETRACYCLINE

Not more than 2.0%

Less than disregard limit

ANHYDROTETRACYCLINE

Not more than 0.5%

0.10%

2-ACETYL ANALOG

Not more than 1.4%

0.71%

CHLORTETRACYCLINE

Not more than 0.2%

Less than disregard limit

DEMETHYLTETRACYCLINE

Not more than 0.2%

Less than disregard limit

ANY INDIVIDUAL UNSPECIFIED IMPURITY

Not more than 0.10%

Less than disregard limit

SUM OF IMPURITIES

Not more than 4.0%

1.86%

ASSAY OF TETRACYCLINE HYDROCHLORIDE

Not Less than 900|ig/mg

982ug/mg

(AS IS)

RESIDUAL SOLVENTS

ACETONE

Not more than 500ppm

11 ppm

1-BU1ANOL

Not more than 5000ppm

830ppm