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Physical & Chemical properties

Storage stability and reactivity towards container material

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Administrative data

Endpoint:
storage stability and reactivity towards container material
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:
other company data
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Principles of method if other than guideline:
Three lots of Lactic acid 90% were tested. One lof of Lactic acid 80% was tested.
The samples were stored in 1L HDPE containers, resembling the commercial packaging.
The samples were store in roomds with controlled temperature and humidity. Conditions were: 25oC, 60% RH and 40oC, 75% RH.
GLP compliance:
no
Type of method:
ambient testing

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Samples were stored for 60 months at 25 degrees C, or 12 months at 40 degrees C, and assayed for colour, concentration, pyrogenicity and concentration of several impurities at 10 timepoints during this period.

Results and discussion

Results:
Concentration of lactic acid was completely stable during the entire storage period. All other parameters were within specifications.
Transformation products:
yes
Identity of transformation productsopen allclose all
No.:
#1
Reference
Reference substance name:
Unnamed
Inventory number:
InventoryMultipleMappingImpl [inventoryEntryValue=EC 200-580-7]
IUPAC name:
acetic acid
CAS number:
64-19-7
Molecular formula:
C2H4O2
Molecular weight:
60.052
No.:
#2
Reference
Reference substance name:
Unnamed
Inventory number:
InventoryMultipleMappingImpl [inventoryEntryValue=EC 200-836-8]
IUPAC name:
acetaldehyde
CAS number:
75-07-0

Applicant's summary and conclusion

Conclusions:
The stability data presented in the next chapter demonstrate that lactic acid is very stable, both at ambient conditions and at elevated temperature. A stability period of at least 5 years is justified. Given the fact that the studies were done with product of 80% and 90% concentration and as the results hardly show any degradation, it is justified to extrapolate the results to products with a concentration covered by that range.
Executive summary:

Three lots of Lactic acid 90% were tested. One lof of Lactic acid 80% was tested.

The samples were stored in 1L HDPE containers, resembling the commercial packaging.

The samples were store in roomds with controlled temperature and humidity. Conditions were: 25oC, 60% RH and 40oC, 75% RH.

Critical on the degradation of lactic acid are color, assay and potential degradation products.

In the pharmaceutical preparation, also endotoxins were tested.