ITEMS | SPECIFICATIONS(EP7.0) |
APPEARANCE: | WHITE OR ALMOST WHITE CRYSTALLINE POWDER |
SOLUBILITY | FREELY SOLUBLE IN WATER,SOLUBLE IN ETHANOL(96 PERCENT) |
IDENSIFICATION (1) A.IR |
IR SPECTRA IS IN ACCORDANCE WITH THAT OF PIRACETAM CRS |
SOLUTION | CLEAR AND COLORLESS |
RELATED SUBSTANCES (BY HPLC) |
1)IMPURITY A,B,C,D: EACH OF THEM NOT MORE THAN 0.1% 2)UNSPECIFIED IMPURITY: EACH NOT MORE THAN 0.1% 3)TOTAL IMPURITIES:NOT MORE THAN 0.3% 4)DISREGARD LIMIT |
HEACY METALS | 10 PPM MAX |
LOSS ON DRYING | 0.1%MAX |
SULPHATED ASH | 0.1%MAX |
RESIDUAL SOLVENT | METHANOL≤0.03% |
ASSAY(ON DRIED BASIS) | 98.0%~102.0% |
MICROBIAL TESTS |
1)BACTERIUMS≤1000CFU/G 2)YEASTS & MOULDS≤100CFU/G 3)ESCHERICHIA COLI: NOT TO BE FOUND 4)MITES:NOT TO BE FOUND |
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