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Active Pharmaceuticals

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  • COA

Chemical name: Fluticasone propionate
MF:C25H31F3O5S
MW:500.57
CAS:80474-14-2
Appearance: White powder

Fluticasone propionate, the active component of Fluticasone Propionate Nasal Spray, is a synthetic corticosteroid having the chemical name S-(fluoromethyl)6α,9-difluoro-11β-17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate.

Image from Drug Label Content
Fluticasone propionate is a white to off-white powder with a molecular weight of 500.6 and the molecular formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.

Fluticasone Propionate Nasal Spray, 50 mcg is an aqueous suspension of microfine fluticasone propionate for topical administration to the nasal mucosa by means of a metering, atomizing spray pump. Fluticasone Propionate Nasal Spray also contains 0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol, and polysorbate 80 and has a pH between 5 and 7.

It is necessary to prime the pump before first use or after a period of non-use (1 week or more). After initial priming (six actuations), each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter. Each 16-g bottle of Fluticasone Propionate Nasal Spray provides 120 metered sprays. After 120 metered sprays, the amount of fluticasone propionate delivered per actuation may not be consistent and the unit should be discarded.

Fluticasone is used by powder or aerosol inhalation for the prophylaxis of asthma. Typical initial doses in the UK range from 100 to 250 micrograms twice daily in mild asthma up to 1 mg twice daily in severe asthma, adjusted according to response. Children over four years of age may be given initial doses of 50 to 100 micrograms twice daily, increased to 200 micrograms twice daily if necessary. The drug may also be given via a nebuliser in severe chronic asthma. Usual adult doses are 0.5 to 2 mg twice daily. Children aged four to sixteen years may be given 1 mg twice daily.

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

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