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Physical & Chemical properties

Additional physico-chemical information

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Reference
Endpoint:
light stability
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
July 1991 to August 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test material was illuminated with a Xenon lamp at 80 000 lux for 1, 4 and 24 hours. The concentration of unchanged test material was determined by HPLC and compared against analogous samples that had been stored in the dark over the same time periods.
GLP compliance:
yes

Illumination Time and Remaining Content in % of the Standard Solution

Sample

Illumination time

(Incubation Time)

(hours)

Lux

Remaining Active Ingredient in

% of Standard Solution

Replicate 1

Replicate 2

Mean

DP 1

1

0

99.9

99.6

99.8

DP 2

1

0

100.3

100.6

100.5

BP 1

1

80 000

97.5

97.7

97.6

BP 2

1

80 000

98.6

98.4

98.5

DP 1

4

0

102.5

102.9

102.7

DP 2

4

0

104.0

102.9

13.5

BP 1

4

80 000

89.7

89.8

89.8

BP 2

4

80 000

95.9

95.7

95.8

DP 1

24

0

99.4

99.6

99.5

DP 2

24

0

99.4

99.7

99.6

BP 1

24

80 000

53.4

53.3

53.3

BP 2

24

80 000

51.9

52.2

32.1

DP: Incubation in the dark.

BP: Illumination 80 000 lux.

The result of the regression analysis was:

m = -84.449626

b = 169.40947

r = -0.9963

The degradation function has the form of:

lg (% unchanged test material) = -84.449626 x (hours) + 169.40947

The degradation time for 80 % and 50 % remaining unchanged test material can be calculated using the aforementioned equation to produce:

lg 80 % = 1.9031 (degradation time = 8.7 hours)

lg 50 % = 1.699 (degradation time = 26 hours)

Conclusions:
Under the conditions of the study, the test material was found to have a light stability with a half life of 26 hours at a light intensity of 80 000 lux and a temperature of approximately 25 °C.
Executive summary:

The light stability of the test material was investigated in a GLP study during which the test material was illuminated with a Xenon lamp at 80 000 lux for 1, 4 and 24 hours. The concentration of unchanged test material was determined by HPLC and compared against analogous samples that had been stored in the dark over the same time periods.

Under the conditions of the study, the test material was found to have a light stability with a half life of 26 hours at a light intensity of 80 000 lux and a temperature of approximately 25 °C.

Description of key information

Light Stability: Redeker (1991)

The test material was found to have a light stability with a half life of 26 hours at a light intensity of 80 000 lux and a temperature of approximately 25 °C

Additional information

Light Stability: Redeker (1991)

The light stability of the test material was investigated in a GLP study during which the test material was illuminated with a Xenon lamp at 80 000 lux for 1, 4 and 24 hours. The concentration of unchanged test material was determined by HPLC and compared against analogous samples that had been stored in the dark over the same time periods.

Under the conditions of the study, the test material was found to have a light stability with a half life of 26 hours at a light intensity of 80 000 lux and a temperature of approximately 25 °C.