Manufacturer EP8 Glucocorticoid Raw Materials Fluticasone Propionate (Flonase) Powder
What is Fluticasone propionate?
Fluticasone propionate belongs to a class of drugs known as corticosteroids, specifically glucocorticoids, which are hormones that predominantly affect the metabolism of carbohydrates and, to a lesser extent, fat and protein. It is used to treat asthma, allergic rhinitis, nasal polyps, various skin disorders and Crohn’s disease and ulcerative colitis. It is also used to treat eosinophilic esophagitis.
Fluticasone propionate Basic Information
CAS No.: 80474-14-2
Synonyms: AtemurMite;Cutivate;Cutivate cream;Cyclesonide;Flixonase;FlixonaseNasal Spray;Flixotide;Flixotide Disk;Flixotide Disks;Flixotide Inhaler;Flonase;Flonase Aq;Flovent;Flovent Diskus;Flunase;Fluticasone17-propionate;
Formula: C25H31F3O5S
Molecular Weight: 500.57
Assay: >98%
Appearance: Crystalline solid
Density: 1.32 g/cm3
Melting Point: 275 °C
Boiling Point: 568.3 °C at 760 mmHg
Flash Point: 297.5 °C
Storage: Keep it under seal in cool and dark place
Fluticasone propionate Certificate of Analysis
| Product name |
Fluticasone propionate |
| CAS No. |
80474-14-2 |
Outer Packing |
100G |
| Production date |
11th Jan 2018 |
Shelf life |
10th Jan 2021 |
| Standard adopted |
EP8 |
| Items of analysis |
Specification |
Results |
| Appearance |
white or almost white powder |
Conform |
| Identification |
IR & HPLC |
Conform |
| Solubility |
Practically insoluble in water |
Conform |
| Specific Rotation |
+32-+36° |
Conform |
| Water |
0.2% max |
0.15% |
| Chromatographic Purity |
≥99.0% |
99.54% |
| Impurity A |
0.2%max. |
Conform |
| Impurity B,C |
0.1%max |
Conform |
| Impurity D,E |
0.3%max. |
Conform |
| Any other impurity |
0.1%max. |
Conform |
| Acetone |
Not more than 1.0% |
Conform |
| DMF |
NMT 880 PPM |
Conform |
| THF |
NMT 720 PPM |
Conform |
| PYRIDINE |
NMT 200 PPM |
Conform |
| METHANOL |
NMT 3000 PPM |
Conform |
| N,N-DIMETHYLACETAMIDE |
NMT 1090 PPM |
Conform |
| Assay (by HPLC) |
97.0% to 102.0% |
99.50% |
| Conclusion |
Qualified |
Fluticasone propionate Medical Uses
Fluticasone is used by powder or aerosol inhalation for the prophylaxis of asthma, the nasal spray is used for prophylaxis and treatment of allergic rhinitis, nasal drops are used in the treatment of nasal polyps, and creams and ointments are applied topically in the treatment of various skin disorders.
It can be given orally in the treatment of Crohn’s disease and ulcerative colitis.
Some benefit was also reported in coeliac disease.
Fluticasone propionate Side effects
Nasal spray: Common side effects may include nasal irritation (burning, stinging, bleeding), headache, stomach upset (nausea, vomiting), and diarrhea. Rare side effects include infection (evidenced by, e.g., fever, sore throat, and cough), vision problems, severe swelling, hoarse voice, and difficulty breathing or swallowing.
Oral inhaler: Common side effects may include upper respiratory tract infection, throat irritation, thrush, cough, and headache. Rare side effects include bruising, swelling of the face/neck, depression, tiredness, and shortness of breath.
