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EC number: 947-794-3 | CAS number: -
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Stability in organic solvents and identity of relevant degradation products
Administrative data
- Endpoint:
- stability in organic solvents and identity of relevant degradation products
- Remarks:
- solvent: ethanol
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: SOP 00191, Version 2
- Version / remarks:
- SOP (Standard Oparating Procedure) by CURRENTA GmbH, Leverkusen, Germany
- Principles of method if other than guideline:
- Homogeneity: Visual inspection
Stability: Calculation of the recovery of the test item in ethanol based on the peak Mannich Base (4x, 3x, 2x substituted). The quantification was performed by HPLC-MS - GLP compliance:
- yes
Test material
- Reference substance name:
- 4-(1-{3,5-Bis[(dimethylamino)methyl]-4-hydroxyphenyl}-1-methylethyl)-2,6-bis[(dimethylamino)methyl]phenol
- Molecular formula:
- C27H44N4O2
- IUPAC Name:
- 4-(1-{3,5-Bis[(dimethylamino)methyl]-4-hydroxyphenyl}-1-methylethyl)-2,6-bis[(dimethylamino)methyl]phenol
- Reference substance name:
- 2,6-Bis[(dimethylamino)methyl]-4-(1-{3-[(dimethylamino)methyl]-4-hydroxyphenyl}- 1-methylethyl)phenol
- Molecular formula:
- C24H37N3O2
- IUPAC Name:
- 2,6-Bis[(dimethylamino)methyl]-4-(1-{3-[(dimethylamino)methyl]-4-hydroxyphenyl}- 1-methylethyl)phenol
- Reference substance name:
- 2-[(Dimethylamino)methyl]-4-(1-{3-[(dimethylamino)methyl]-4-hydroxyphenyl}-1-methylethyl)phenol
- Molecular formula:
- C21H30N2O2
- IUPAC Name:
- 2-[(Dimethylamino)methyl]-4-(1-{3-[(dimethylamino)methyl]-4-hydroxyphenyl}-1-methylethyl)phenol
- Reference substance name:
- Unknown impurities
- IUPAC Name:
- Unknown impurities
- Reference substance name:
- Xylene
- EC Number:
- 215-535-7
- EC Name:
- Xylene
- Cas Number:
- 1330-20-7
- Molecular formula:
- C8H10
- IUPAC Name:
- Benzene, dimethyl-
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Reference substance name:
- Sulphated ash
- IUPAC Name:
- Sulphated ash
- Test material form:
- solid: bulk
- Details on test material:
- - Name of test material (as cited in study report): HPP 12879-1
Constituent 1
Constituent 2
Constituent 3
impurity 1
impurity 2
impurity 3
impurity 4
Results and discussion
- Test substance stable:
- yes
- Remarks:
- According to SOP 00191 Version 2, the 0.01 mg/mL and 423 mg/mL formulation of the test item in ethanol are homogeneous and stable for at least 24 hour at room temperature.
Any other information on results incl. tables
Homogeneity:
The formulation 0.01 mg/mL and 423 mg/mL are clear solutions and therefore homogeneous.
Stability:
Calculation of recovery of the test item in ethanol based on peak Mannich Base (4x substituted)
Nominal value mg/mL |
Theoretical value Mg/mL |
Content test item mg/mL |
Recovery as % of theoretical value |
||
Start |
After 24 hours |
Start |
After 24 hours |
||
0.01 |
0.0101 |
0.0102 |
0.0098 |
101 |
97 |
423 |
423 |
419 |
430 |
99 |
101 |
Calculation of recovery of the test item in ethanol based on peak Mannich Base (3x substituted)
Nominal value mg/mL |
Theoretical value Mg/mL |
Content test item mg/mL |
Recovery as % of theoretical value |
||
Start |
After 24 hours |
Start |
After 24 hours |
||
0.01 |
0.0101 |
0.0103 |
0.0104 |
102 |
103 |
423 |
423 |
432 |
424 |
102 |
100 |
Calculation of recovery of the test item in ethanol based on peak Mannich Base (2x substituted)
Nominal value mg/mL |
Theoretical value Mg/mL |
Content test item mg/mL |
Recovery as % of theoretical value |
||
Start |
After 24 hours |
Start |
After 24 hours |
||
0.01 |
0.0101 |
0.0104 |
0.0101 |
103 |
100 |
423 |
423 |
435 |
445 |
103 |
105 |
Applicant's summary and conclusion
- Conclusions:
- The 0.01 mg/mL and 423 mg/mL formulations of HPP 12879-1 in ethanol are homogeneous and stable for at least 24 hours at room temperature.
- Executive summary:
According to SOP 00191 Version 2, the 0.01 mg/mL and 423 mg/mL formulations of HPP 12879 -1 in ethanol are clear and therefore homogeneous. They are stable for at least 24 hour at room temperature.
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