Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
report date: 2006-05-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: HPLC method
Principles of method if other than guideline:
HPLC method
(please refer to section on details on analytical methods)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Fusidic acid
EC Number:
230-256-0
EC Name:
Fusidic acid
Cas Number:
6990-06-3
Molecular formula:
C31H48O6
IUPAC Name:
2-[(1Z,2S,3aS,3bS,5aS,6S,7R,9aS,9bS,10R,11aR)-2-(acetyloxy)-7,10-dihydroxy-3a,3b,6,9a-tetramethyl-hexadecahydro-1H-cyclopenta[a]phenanthren-1-ylidene]-6-methylhept-5-enoic acid
Test material form:
solid: crystalline
Details on test material:
Details are given for each individual study
Specific details on test material used for the study:
fusidic acid (WG-564-000) in mixtures of acetonitrile and McIlvaine (phosphate-citrate) buffers
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Details on sampling:
Samples were taken at different times and immediately analysed by HPLC. The rate constants and the time for 50% decomposition in different mixtures were determined.
Buffers:
The stability of fusidic acid in mixtures of acetonitrile and McIlvaine (phosphate-citrate) buffers, pH = 2, pH = 4.0, pH = 5.5, pH =7.4 and pH = 8.0 (1:1) (250 µg/L) has been investigated at 60+/-2°C. The stability of fusidic acid in mixtures of acetonitrile and isotonic phosphate buffers, pH =7.4 (1:1) (250 µg/L) has been investigaed at 25+/-2°C and at 40+/-2°C.
Number of replicates:
NA
Positive controls:
not specified
Negative controls:
not specified
Statistical methods:
NA

Results and discussion

Transformation products:
yes
Identity of transformation productsopen allclose all
No.:
#1
Reference
Reference substance name:
Unnamed
IUPAC name:
NA
CAS number:
NA
Molecular formula:
NA
No.:
#2
Reference
Reference substance name:
Unnamed
IUPAC name:
NA
CAS number:
NA
Dissipation DT50 of parent compoundopen allclose all
Key result
pH:
2
Temp.:
60 °C
Hydrolysis rate constant:
0.003 h-1
DT50:
10 d
Remarks on result:
other: in solution, McIlvaine
Key result
pH:
4
Temp.:
60 °C
Hydrolysis rate constant:
0.001 h-1
DT50:
32 d
Remarks on result:
other: in solution, McIlvaine
Key result
pH:
5
Temp.:
60 °C
Hydrolysis rate constant:
0.005 h-1
DT50:
5.9 d
Remarks on result:
other: in solution, McIlvaine
Key result
pH:
7
Temp.:
60 °C
Hydrolysis rate constant:
0.008 h-1
DT50:
3.5 d
Remarks on result:
other: in solution, McIlvaine
Key result
pH:
8
Temp.:
60 °C
Hydrolysis rate constant:
0.007 h-1
DT50:
3.9 d
Remarks on result:
other: in solution, McIlvaine
Key result
pH:
7.4
Temp.:
40 °C
Hydrolysis rate constant:
0.001 h-1
DT50:
54 d
Remarks on result:
other: Isotonic phosphate
Details on results:
At 60+/-2°C, fusidic acid is most stable towards hydrolysis at pH =4. Above pH 4, the stability decreases with increasing pH. Less than 1% fusidic acid was degraded after 14 days in mixtures of acetonitrile and isotonic buffer, pH =7.4 (1:1) at 25+/-2°C.

Applicant's summary and conclusion

Conclusions:
At 60+/-2°C, fusidic acid is most stable towards hydrolysis at pH =4. Above pH 4, the stability decreases with increasing pH. Less than 1% fusidic acid was degraded after 14 days in mixtures of acetonitrile and isotonic buffer, pH =7.4 (1:1) at 25+/-2°C.
Executive summary:

The stability of fusidic acid in mixtures of acetonitrile and McIlvaine (phosphate-citrate) buffers, pH = 2.0, pH = 4.0, pH = 5.5, pH =7.4 and pH = 8.0 (1:1) (250 µg/L) has been investigated at 60+/-2°C. The stability of fusidic acid in mixtures of acetonitrile and isotonic phosphate buffers, pH =7.4 (1:1) (250 µg/L) has been investigaed at 25+/-2°C and at 40+/-2°C. Samples were taken at different times and immediately analysed by HPLC. The rate constants and the time for 50% decomposition in different mixtures were determined.

At 60+/-2°C, fusidic acid is most stable towards hydrolysis at pH =4. Above pH 4, the stability decreases with increasing pH. Less than 1% fusidic acid was degraded after 14 days in mixtures of acetonitrile and isotonic buffer, pH =7.4 (1:1) at 25+/-2°C.