Meclizine Dihydrochloride CAS NO.1104-22-9

Analysis Test

Specification

Result

Description

yellow crystalline powder,odorless

Conforms

Solubility

Easily soluble in water, unsoluble in ethanol

Conforms

PH

6.0~7.5

6.9

Solution clarity and color

solution should be clear and colorless

Conforms

Related substances

5’CMP 0.3%

Simple impurity

Total other impurity

0.01%

0.03%

0.10%

Chloride

0.05%

Conforms

Ammonium

0.05%

Conforms

Fe

0.01%

Conforms

Phosphate

0.1%

Conforms

Loss on drying

≤6.0%

1.3%

Heavy metals

0.002%

Conforms

Arsenide

0.0001%

Conforms

Bacterial Endotoxins

0.3EU/mg

Conforms

Microbial Limit

Conforms

Conforms

Assay(on dried basis)

≥98.0%

98.8%

Conclusion: The results conform with CP2010