Anastrozole CAS: 120511-73-1 USP

ANALYSIS

SPECIFICATIONS

RESULTS

Appearance

White to off-white crystalline powder

Off-white crystalline powder

Identification

Conform with standard IR/MS

Conforms 

HPLC and peak shape

Correspond to reference

Conforms

Related Substances(HPLC)

Total impurity

≤0.5%

0.07%

Single other impurity

≤0.1%

0.04%

Impurity A

≤0.2%

N/D

Impurity B

≤0.2%

N/D

Impurity C

≤0.1%

N/D

Impurity D

≤0.1%

N/D

Limit of solvent(in house)

n-hexane

≤0.029%

0.005%

Ethyl acetate

≤0.5%

0.08%

Solubility

Very soluble in acetonitrile;freely soluble in methanol,in acetone,in alcohol,and in tetrahydrofuran.

Conforms

Loss on drying(in house)

≤0.5%

0.02%

Melting point(in house)

81.0 ~ 84.0℃

82.0 ~ 83.0℃

Residue on ignition

≤0.1%

0.01%

Assay(HPLC)

98.0% - 102.0% on the anhydrous and solvent – free basis

100.3%

Water(KF)

≤0.3%

0.02%

Storage

Preserve in well-closed container,store at room temperature

Shelf Life

48 months