PARACETAMOL DC90

ITEMS

STANDARDS

RESULTS

APPEARANCE

WHITE OR ALMOST WHITE GRANULES

WHITE GRANULES

INDENTIFICATION

(1),(2)

CONFORMS

CONFORMS

ASSAY

87.5-92.5%

89.9%

LOSS ON DRYING

NOT MORE THAN 2.4%

1.6%

GRANULARITY

PASS USS10 MESH COMPLETELY

NOT MORE THAN 10% CAN’T PASS USS20 MESH

NOT MORE THAN 25% PASS USS80 MESH

PASS USS10 MESH COMPLETELY

9.1%

21.47%

DENSITY

0.57-0.63G/CM3

0.62G/CM3

MICROBIA LIMIT:

BACTERIA

MOLDS AND YEATS

ESCHERICHIA COIL

NMT 1000CFU/G

NMT 100CFU/G

NONE

30CFU/G

15CFU/G

NONE

CONCLUSION: COMPLIES WITH EXPORT STANDARD