Test

Acceptance Criteria

Results

Description

A white to off-white,crystalline powder

White crystalline powder

Solubility

Very slighty soluble in water,Acetonitrile,

Slightly soluble in Methanol(95%).Soluble in Methanol,Soluble Dimethl dimethylSulphoxide

Complies

Identification

a.By IR Absorptiom

b.By SOR

c.By HPLC

Complies

Specific Optical Rotation

[α]_D²⁵,in DMSO

Between-6.0 to -10.0

-7.6

Water Content(By KF)

Between 3.50% w/w to 5.0% w/w

4.7%

Heacy Metals

NMT 20 ppm (0.002%)

＜20ppm

Calcium Content

(On anhydros basis)

Between 3.2% w/w to 3.8% w/w

3.5

Assay(By HPLC)

Content of Atorvastatin Calcium

99.0% w/w to 101.0% w/w

99.3%

Enantiomeric Purity(By HPLC)

NMT 0.20%

0.04%

Related

substances

（By HPLC）

Any known individual

impurity:

NMT0.15%

0.14%

Any unknown individual

impurity:

NMT0.10%

0.09%

Total impurity:

NMT1.00%

0.5%

Residual

solvents

(By GC)

Ethanol

NMT 5000ppm

＜17ppm

Toluene

NMT 890ppm

92ppm

n-Hexane

Nmt 290ppm

4ppm

Microbial

Limits

Total acrobic microbial count

NMT 1000cfu/g

＜10cfu/g

Total yeast and mould count

NMT 100cfu/g

＜100cfu/g

Escherichia coli

Should be absent in 1g

ND

Salmonella spp

Should be absent in 10g

ND

Particle size dietribution

d(0.9)-Not more than 10.0 microns

9.0 micron