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Test |
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Specification |
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Description |
: |
A White to off-white crystalline powder |
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Solubility |
: |
Freely soluble in methanol, slightly soluble in ethanol (95%) and very slightly soluble in water. |
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Identification
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: |
|
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a) By infrared Spectrophotometer |
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The spectrum of Atorvastatin Calcium is concordant with the spectrum obtained from the working standard. |
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b) Test for Calcium |
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Positive |
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Specific Optical rotation (on anhydrous basis) |
: |
Between -6.0° and -12.0° |
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Related Substances by HPLC
a) Highest Individual impurity
b) Total impurities |
: |
Not more than0.5% w/w
Not more than 2.0% w/w |
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Water content by Kf |
: |
Between 3.0% and 7.0% w/w |
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Heavy Metals |
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Not more than 20 ppm |
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Saay by HPLC |
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Not less than 98.0% and Not more than 102.0% w/w |
