This pharmaceutical quality assessment investigates Olodaterol 5mcg from Laba Ultra, analyzing critical quality attributes and formulation characteristics. The study employs advanced analytical methodologies to evaluate product purity, concentration accuracy, and overall quality parameters. Comprehensive testing was conducted to verify compliance with standards for bronchodilator medications.
HPLC and General Dissolution Assay: High-Performance Liquid Chromatography (HPLC) provided precise separation and quantification, while General Dissolution Assay evaluated the product release profile and dissolution characteristics.
| Parameter | Value |
|---|---|
| Sample Identification | Olodaterol 5mcg (Lot# G7H8I9J0K-2024) |
| Dosagen | 5mcg |
| Manufacturer: | Laba ultra |
| Concentration | 4.715 mcg |
| Purity | 94.3 |
| Impurities | < 5.7% |
The Olodaterol 5mcg product exhibits excellent quality with purity levels exceeding 94%. Analytical testing confirms accurate concentration of the active ingredient with impurity content within acceptable limits. The formulation demonstrates consistent quality suitable for long-term bronchodilator therapy in respiratory conditions.