Diltiazem HCL

Characteristics

A white Crystalline powder

Conforms

Identification   (by HPLC)

Corresponds to the requirement of the reference   standard

      Conforms

Specific   optical  rotation

+110⁰-+116⁰

      +114.8⁰

Assay (on   dried)

98.5%-101.5%

      99.565%

Melting   range

210℃-215℃

213.0℃-213.5℃

Loss on   drying

≤0.5%

      0.26%

Residue   on ignition

≤0.1%

      0.07%

PH

4.3-5.3

      5.0

Heavy   metals

≤20ppm

      Conforms

Related   substances:

(1)      Single impurity

(2)      Total impurity

≤0.5%

≤1.0%

0.31%

      0.56%

Analytical   conclusion

Conforming to USP32