Atropine Sulfate

Test Items

Standard

Character

A white or almost white amorphous powder

Specific Optical Rotation

-7.0°~9.0°

Water

≤3.5%

SOLUBILITY

40 °C Soluble in tetrahydrofuran, 20 °C

slightly soluble in water, Insoluble in

ether.

PARTICLE SIZE

180-150μm

Ca %

3.0~3.6

Heavy Metals(ppm)

≤10

X-RAY Diffraction

amorphous 

Impurity

(HPLC)

Atorvastatin Lactone ≤0.1%

Desfluoro-atorvastatin calcium ≤0.2%

Diamine –atorvastatin calcium ≤0.3%

Isomer-atorvastatin calcium ≤0.2%

Other individual unknown Impurity %≤0.2%

Total impurities≤1.0%

Assay

98.0-102.0%