CHEMICAL NAME: (3R,5S,6E)-7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[N-methyl(n-methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-Heptenoic calcium
Item
|
Standard
|
Descripition
|
White or Yellow powder
|
Identification
|
• IR-Spectrum
• UV
|
Water
|
≤ 0.5 %
|
Specific rotation
|
19.0-23.0
|
Heavy metals
|
≤ 0.002%
|
Related substance (HPLC)
|
Diastereomer
|
≤ 0.15%
|
Rosuvastatin Lactone
|
≤ 0.20%
|
Diene
|
≤ 0.10%
|
Unknown single impurity
|
≤ 0.10%
|
Total impurity
|
≤ 2.0%
|
Assay ( on dry basis )
|
98.0-102.0%
|
Packing Size |
Less than 1Kg : Foil Bags |
Less than 20 Kg : Big or small Aluminum barrel or Cartons |
More than 20 Kg : 25KG/ Bins or Cartons |
Note |
Powder |
|