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$785.50 - $785.70 / Kilogram
Mirabegron is a potent bladder relaxant. The compound activates the β3 adrenergic receptor in the detrusor muscle in the bladder leading to relaxation of the bladder muscles.
| Item | Specification | Result |
| Appearance | White powder | Complies |
| Related substance (HPLC) | Total impurity ≤0.5% Max single impurity ≤0.1% | 0.2% 0.06% |
| Odor | Characteristic | Complies |
| Assay | 99% | 99.8% |
| Sieve analysis | 100% pass 80 mesh | Complies |
| Loss on Drying Residue on Ignition | ≤1.0% ≤1.0% | 0.12% 0.09% |
| Heavy Metal | <10ppm | Complies |
| As | <0.1ppm | 0.05ppm |
| Pb | <0.1ppm | 0.05ppm |
| Cd | <0.1ppm | 0.05ppm |
| Residual Solvents | <100ppm | Complies |
| Residual Pesticide | Negative | Complies |
| Microbiology | ||
| Total Plate Count | <1000cfu/g | Complies |
| Yeast & Mold | <100cfu/g | Complies |
| E.Coli | Negative | Complies |
| Salmonella | Negative | Complies |
Mirabegron 3 is a beta - adrenergic agonist suitable for urge incontinence, urgency, and urinary frequency symptom of overactive bladder ( OAB ) treatment.
(1) the recommended starting dose is 25 mg 1 time per day, with or without food.
(2) 25 mg is effective within 8 weeks. Based on individual efficacy and tolerability, dose can be increased to 50 mg 1 time per day.
(3) complete with water to swallow, don't chew, split or crushed.
(4) patients with severe renal impairment or in patients with moderate hepatic impairment, the maximum dose is 25 mg 1 time per day.
(5) have end-stage renal disease (ESRD) patients or in patients with severe hepatic impairment. Not recommended for use
Use in special populations
(1) the pregnancy only if the benefit to the mother outweighs the potential risks to the fetus is only used when.
(2) nursing mothers: Myrbetriq is expected to be excreted in human milk and nursing mothers is not recommended.
(3) children: has not been established in children with Myrbetriq safety and effectiveness.
(4) elderly: proposal on recommends no dose adjustment in elderly patients.
