Stability of Levothyroxine Sodium Injection in Polypropylene Syringes
Author(s): Gupta Vishnu D
Issue: Nov/Dec 2000 - Compounding for Hormone Replacement Therapy
View All Articles in Issue
Page(s): 482-483
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Abstract: A stability-indicating high-performance liquid chromatography
assay method was used to study the stability of levothyroxine
sodium injection (100 µg/mL) in 0.9% sodium chloride
injection after being stored at 5°C in polypropylene syringes.
The method developed is accurate and precise and has a percent
relative standard deviation of 1.3 based on 5 readings. The
concentrations of the drug were directly related to the peak
heights. The drug in the injection did not adsorb onto the
polypropylene syringes. After 7 days of storage at 5°C, the injection
was clear, the pH value had not changed, and there was
no loss in the potency of levothyroxine sodium. The manufacturer’s
recommendation that the injection be used immediately
after reconstitution is very conservative.
Related Keywords:
levothroxine, levothyroxine injection, polypropylene syringes, stability, Synthroid
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