Header for print stylesheet
You are here:  

Atorvastatin Calcium Crystalline Characteristics:
A crystalline powder

Application:
A crystalline powder suitable for the manufacture of tablets and capsules. The appropriate excipients need to be added. The particle size of the product is designed in such a way that optimal dissolution can be obtained (depending on formulation).

Therapeutical category: 
Cholesterol lowering agent.

Pharmacopoeia quality:
USP. Ph.Eur. 

Regulatory information:
USA: DMF 23052
EU: EDMF
other pending registrations

Packaging:
Two polyethylene bags tied independently and a sealed laminate outer bag in a blue HDPE drum.

Quantity per package: 5 and 10 kg

Appearance: 
White to off white crystalline powder

Assay (as Ca salt on anhydrous basis):
98.0 -102.0%

Total impurities:
NMT 1.0%

Morphology:
Crystalline 

Water content (Karl Fischer):
3.5-5.5%

Residual solvents:
NMT 5000 ppm

Retest period:
2 years (based on current available data, will be exended)

Storage conditions:
Keep container closed below 30°C in a dry place

To the best of our knowledge, the information contained herein is accurate. The information is "as is", without guaranty or warranty of any kind, either expressed or implied, including, but not limited to, the implied waranties of merchantability, fitness for a particular purpose, or non-infringement. This information is strictly for informative purposes and intended only for those jurisdictions where the product is not protected by valid and enforceable patent rights.

footer for print stylesheet