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Physical & Chemical properties

Additional physico-chemical information

Administrative data

Endpoint:
additional physico-chemical information
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Start: 09 October 2008. Completion: 16 March 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The purpose of this study is to determine the stability of the test substance during the dosing period, and homogeneity, stability and concentration of the test substance in formulation in "Twenty-Eight-Day Repeated-Dose Oral Toxicity Study of KarenzMT (Mixture of PEMB andPE3MB) in Rats" (Study Code: BII-0908).
GLP compliance:
yes
Remarks:
GLP statement signed March 16 2009
Endpoint investigated:
other: Stability, homogeneity and concentration during dosing period of 28-day study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Karenz MT (Mixture of PEMB and PE3MB)
- Substance type: Monoconstituent
- Physical state: Yellow, clear liquid
- Analytical purity: 95.8 % (PEMB: 81.7%, PE3MB 14.1%)
- Lot/batch No.: PE080805
- Expiration date of the lot/batch: not stated in the report
- Storage condition of test material: Dark storage place at room temperature and avoided contacting with oxidizing agent.

Results and discussion

Results:
The test substance (KarenzMT (Mixture of PEMB and PE3MB)) was stable during the dosing period of subject study (Study Code: B11-0908).The test substance in 10.0 and 0.25 w/v% formulations was stable for 8 days after preparation at cold and dark place and showed good homogeneity. The concentration oftest substance in 10.0, 1.5 and 0.25 w/v% dose formulations for subject study was acceptable level.

Any other information on results incl. tables

Stability Analysis of the Test Substance

IR spectrum of test substance provided by the sponsor was identical with that measured before dosing period for subject study (Figure 1). There were no differences in the IR spectra between before and after dosing period (Figures 1,2).

Homogeneity, Stability and Concentration Analyses of the Test Substance Formulation

1) Homogeneity and Stability Analyses

The results of homogeneity and stability analyses of the test substance formulation are shown in Table 1.

(I) Homogeneity Analysis CV of 10.0 and 0.25 w/v% formulations were 0.6 and 1.0%, respectively. The results satisfied criteria for judgment.

(2) Stability Analysis

a) 10.0 w/v% Formulation

At immediately after preparation, R.N. were 101 to 102%.

At 3 days after preparation, R.N. was 100%, and R.P. was 98.0%.

At 9 days after preparation, R.N. was 101 %, and R.P. was 99.0%.

All the results of R.N. and R.P. satisfied criteria for judgment.

b) 0.25 w/v% Formulation

At immediately after preparation, R.N. were 102 to 104%.

At 3 days after preparation, R.N. was 102%, and R.P. was 99.6%.

At 9 days after preparation, R.N. was 102%, and R.P. was 100%.

All the results of R.N. and R.P. satisfied criteria for judgment.

2) Concentration Analysis

The results of concentration analysis of the test substance formulation are shown in Table 2. R.N. of 10.0, 1.5 and 0.25 w/v% dose fonnulations were 99.1 to 101%. All the results satisfied criteria for judgment.

Applicant's summary and conclusion

Conclusions:
The test substance was stable in formulations during the dosing period of subject study.The test substance in 10.0 and 0.25 % (w/v) formulations was stable for 8 days after preparation when stored at a cold and dark place and showed good homogeneity. The concentration of test substance in 10.0, 1.5 and 0.25 % (w/v) dose formulations for subject study was at acceptable level.
Executive summary:

The purpose of this study is to determine the stability of the test substance in formulation during the dosing period, and homogeneity, stability and concentration of the test substance in formulation in "Twenty-Eight-Day Repeated-Dose Oral Toxicity Study of KarenzMT (Mixture of PEMB and PE3MB) in Rats" (Study Code: BII-0908).

The test substance was stable in formulation during the dosing period of subject study. The test substance in 10.0 and 0.25 % (w/v) formulations was stable for 8 days after preparation when stored at a cold and dark place and showed good homogeneity. The concentration of test substance in 10.0, 1.5 and 0.25 % (w/v) dose formulations for subject study was at acceptable level.