lithium hydrogen 7-{(E)-[2-amino-4-(2-naphthyl)-1,3-thiazol-5-yl]diazenyl}naphthalene-1,3,5-trisulfonate (2:1:1)

Storage stability and reactivity towards container material

Administrative data

Endpoint:

storage stability and reactivity towards container material

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Stusy test phase 2013-04-30 to 2013-06-14. Report complete 2013-10-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study meets the criteria for classification as Reliable without Restriction according to Klimisch et al (1997).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

CIPAC MT 46.3 (Storage Stability)

Deviations:

no

GLP compliance:

yes

Type of method:

accelerated testing

Test material

Test material information

Constituent 1

Reference substance name:

lithium hydrogen 7-{(E)-[2-amino-4-(2-naphthyl)-1,3-thiazol-5-yl]diazenyl}naphthalene-1,3,5-trisulfonate (2:1:1)

EC Number:

940-433-0

Molecular formula:

C23H14Li2N4O9S4

IUPAC Name:

lithium hydrogen 7-{(E)-[2-amino-4-(2-naphthyl)-1,3-thiazol-5-yl]diazenyl}naphthalene-1,3,5-trisulfonate (2:1:1)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Specific details on test material used for the study:

Reactivials with inert tops were filled, in duplicate, to give minimum headspace with the test material. The vials were then sealed with tape and labelled before weighing. A blank vial was also prepared. The vials were placed in an oven for 14 days at 54 ± 2oC.

After 14 days the vials were removed from storage and left to equilibrate at room temperature before the appearance and weight of the vials were recorded.

The strength and impurity profile of the test item after storage was also determined by HPLC. In the absence of any appropriate reference material, the stability test material was compared with the test item stored at ambient temperature.

Results and discussion

Results:

PRODUCT APPEARANCE
- No change in the appearance of the test material was noted

MASS CHANGES
- Initial total mass (product): 31.08477g
- Mass at sampling (product): 31.030605g
- Mass change (%): 0.175

The accelerated storage strength of the test material after 14 days at 54 C was 98.4 % w/w of the unstressed test material.

The impurity profile of the test material after 14 days at 54 C was the same as the unstrssed test material.

Transformation products:

no

Applicant's summary and conclusion

Conclusions:

Over the test time period the test material was shown to be stable. There had not been any significant active ingredient degradation which indicates an ambient shelf life of 2 years.

Executive summary:

Introduction

This study was undertaken to determine the storage stability of the test material. The method used was in accordance with CIPAC MT 46.

Results & Conclusion

No change in the appearance of the test material was noted during the study. The weight loss of the test material after 14 days at 54 C was consistent with the blank. The accelerated storage strength of the test material was 98.4 % w/w of the unstressed test material.

The impurity profile of the test material was the same as the unstrssed test material. Over the test time period the test material was shown to be stable. There had not been any significant active ingredient degradation which indicates an ambient shelf life of 2 years.