Name of the Impurity

RT

RRT

Control sample

1% H₂O₂/

RT/

60 min

1% H₂O₂/

60˚C/

90 min

3% H₂O₂/

60˚C/

90 min

6% H₂O₂/

60˚C/

120 min

10% H₂O₂/

60˚C/

120 min

API

Thermal/

80˚C/

24 Hours

API-Heat Hydrolysis/

60˚C/24 Hrs

API-UV Light 48 Hours

API-Visible Light 168 Hours

1 N HCl

RT 1 Hr

5.0 N NaOH/

60˚C/24 Hrs

Picosulfate EP Impurity C Disodium Salt

17.4

1.51

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

Sodium Picosulfate Benzyl Alcohol

8.6

0.73

0.03

0.03

0.250

1.077

2.127

2.440

0.03

0.03

0.02

0.03

0.03

0.03

Picosulfate Impurity 2

29.6

2.57

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

Picosulfate Impurity 3

13.3

1.16

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

Picosulfate Impurity 4

32.0

2.78

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

Picosulfate Impurity 5

23.2

2.02

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

Picosulfate Impurity 6

9.4

0.82

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

Picosulfate Impurity 8

24.8

2.16

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

Picosulfate Impurity 9

13.0

1.13

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

Picosulfate Impurity 10

6.4

0.56

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

Picosulfate Impurity 11

3.9

0.32

ND

ND

ND

ND

ND

0.1

ND

ND

ND

ND

ND

ND

Picosulfate Impurity 12

33.3

2.90

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

Picosulfate Impurity 13

33.2

2.89

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

Sodium Picosulfate EP Impurity A (Monoester)

23.6

2.00

0.04

0.076

0.246

0.477

0.493

0.493

0.06

0.04

0.08

0.05

0.10

0.05

Sodium Picosulfate EP Impurity B (Phenolaldehyde)

27.5

2.39

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND

ND