ITEM |
STANDARD |
|
CHARACTER |
A WHITE OR ALMOST WHITE POWDER |
|
IDENTIFICATION |
POSITIVE REACTION |
|
SPECIFIC OPTICAL |
+14 - +22 |
|
PH |
5.6 - 7.2 |
|
RELATED IMPURITIES (%) |
TOTAL IMPURITY(%) |
≤ 1.0 |
INDIVIDUAL IMPURITY(%) |
≤ 0.5 |
|
LOSS ON DRYING (%) |
≤5.0 |
|
Ca (%) |
3.5 - 4.5 |
|
HEAVY METALS (UG/G) |
≤20 |
|
ASSAY (ON UNHYDROUS BASIS) (%) |
≥98.5 |