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5. Æ¥·¥Ë¾ËûÍ¡â}Pitavastatins Calcium

monocalciumbis[(3R,5S,6E)-7-(2-Cyclopropyl-4-(4-Fluorophenyl)-3-Quinolyl)-3,5-Dihydroxy-6-heptenoate](+)¦Á£­ Phenethylamine Salt
CAS: 147526-32-7
+ëp{(3R,5S,6E)-7-[2-­h(hu¨¢n)±û»ù-4-(·ú´ú±½»ù)à­ßø-3-±½»ù]-3,5-¶þÁu»ù-6-¸ýÏ©ËáÒÒõ¥}â}û}(2:1)

P-5


  ITEM

  STANDARD

  CHARACTER

  A WHITE OR ALMOST
  WHITE POWDER

  IDENTIFICATION

  POSITIVE REACTION

  SPECIFIC OPTICAL
  ROTATION ( ¡ã )

  +14 - +22

  PH

  5.6 - 7.2

  RELATED IMPURITIES (%)

  TOTAL IMPURITY(%)

  ¡Ü 1.0

  INDIVIDUAL IMPURITY (%)

  ¡Ü 0.2

  LOSS ON DRYING (%)

  ¡Ü5.0

  Ca (%)

  3.5 - 4.5

  HEAVY METALS (UG/G)

  ¡Ü20

  ASSAY
  (ON UNHYDROUS BASIS) (%)

  ¡Ý 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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