In stability testing, gonadorelin acetate drug substance was stable for at least 12 months at 24 degrees C and 50% relative humidity, with no degradation under accelerated storage.
In plain wordsIn lab tests, gonadorelin acetate powder stayed stable for at least 12 months at 24 degrees C and showed no breakdown under harsh storage.
- Peptide
- Gonadorelin (GnRH, LHRH)
- Outcome
- Not applicableDrug substance stability
- Study
n: not reported in source
HPLC stability testing- Outcome group
- Formulation, delivery and stability · Pharmacology
Measurements
- stability duration
- ≥ 12 months
- 24 degrees C, 50% relative humidity
Source sentences
The gonadorelin acetate drug substance was found to be stable for at least 12 months when stored at 24 degrees C in 50% relative humidity, and showed no degradation even under accelerated storage conditions.
1 context sentence(design, population, supporting numbers)
Both the purity and potency of the drug substance, the lyophilized product for injection, and the reconstituted material that would be transferred to the infusion pump system were monitored using high-performance liquid chromatography.
In this study, Gonadorelin (GnRH, LHRH) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Gonadorelin (GnRH, LHRH).