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>>Cardiovascular API >>Pitavastatins Calcium
 
5. Pitavastatins Calcium

monocalciumbis[(3R,5S,6E)-7-(2-Cyclopropyl-4-(4-Fluorophenyl)-3-Quinolyl)-3,5-Dihydroxy-6-heptenoate](+)a- Phenethylamine Salt
CAS: 147526-32-7
monocalciumbis[(3R,5S,6E)-7-(2-Cyclopropyl-4-(4-Fluorophenyl)-3-Quinolyl)-3,5-Dihydroxy-6-heptenoate](+)α- Phenethylamine Salt


  ITEM

  STANDARD

  CHARACTER

  A WHITE OR ALMOST
  WHITE POWDER

  IDENTIFICATION

  POSITIVE REACTION

  SPECIFIC OPTICAL
  ROTATION (°)

  +14-+22

  PH

  5.6-7.2

  RELATED IMPURITIES (%)

  TOTAL IMPURITY(%)

  ≤ 1.0

  INDIVIDUAL IMPURITY (%)

  ≤ 0.2

  LOSS ON DRYING (%)

  ≤5.0

  Ca (%)

  3.5 - 4.5

  HEAVY METALS (UG/G)

  ≤20

  ASSAY
  (ON UNHYDROUS BASIS) (%)

  ≥ 98.5

  Less than 1Kg: Foil Bags
Packing Size Less than 20 Kg: Big or small Aluminum barrel or Cartons
  More than 20 Kg: 25KG / Bins or Cartons

 
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