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Appearance: | White Powder | CAS Number: | 80474-14-2 |
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MF: | C25H31F3O5S | MW: | 500.57 |
MOQ: | 1g | Usage: | Pharmaceutical Raw Materials |
High Light: | Injectable Local Anesthetics,Local Anesthetic Powder |
White Raw Pharmacy 99% Fluticasone Propionate Powder CAS: 80474-14-2 for Treating Asthma
Quick Details:
Chemical name: Fluticasone propionate
MF:C25H31F3O5S
MW:500.57
CAS:80474-14-2
Appearance: White powder
MOQ: 1g
Delivery time: 3~7 working days
Payment methods: T/T, , Moneygram, Bitcoin
COA:
Product name | Fluticasone propionate | |||
CAS No. | 80474-14-2 | Outer Packing | 100G | |
Production date | 2016.08.02 | Shelf life | 2018.07.31 | |
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 |
Description:
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.
Medical uses:
Asthma
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.
Allergic rhinitis
Nasal spray preparation of fluticasone propionate is used in the prophylaxis and treatment of allergic rhinitis. The usual dose is 100 micrograms into each nostril once daily, increased if necessary to 100 micrograms into each nostril twice daily. Children aged 4-11 years may be given half these doses.
Nasal polyps
Fluticasone propionate nasal drops are used in the treatment of nasal polyps.
Do NOT use fluticasone furoate spray if:
you are allergic to any ingredient in fluticasone furoate spray
you have recently had an open sore in your nose, nasal surgery, or a nasal injury and it has not healed yet
you are taking ritonavir
Contact your doctor or health care provider right away if any of these apply to you.
Dosage:
Patients should use Fluticasone Propionate Nasal Spray at regular intervals for optimal effect.
Adult patients may be started on a 200 mcg once daily regimen (two 50 mcg sprays in each nostril once daily). An alternative 200 mcg/day dosage regimen can be given as 100 mcg twice daily (one 50 mcg spray in each nostril twice daily).
Individual patients will experience a variable time to onset and different degree of symptom relief. In four randomized, double-blind, vehicle placebo-controlled, parallel-group allergic rhinitis studies and two studies of patients in a outdoor “park” setting (park studies), a decrease in nasal symptoms in treated subjects compared to placebo was shown to occur as soon as 12 hours after treatment with a 200 mcg dose of Fluticasone Propionate Nasal Spray. Maximum effect may take several days. Regular-use patients who have responded may be able to be maintained (after 4 to 7 days) on 100 mcg/day (one spray in each nostril once daily).
Pediatric patients (4 years of age and older) should be started with 100 mcg (one spray in each nostril once daily). Treatment with 200 mcg (two sprays in each nostril once daily or one spray in each nostril twice daily) should be reserved for pediatric patients not adequately responding to 100 mcg daily. Once adequate control is achieved, the dosage should be decreased to 100 mcg (one spray in each nostril) daily.
Maximum total daily doses should not exceed two sprays in each nostril (total dose, 200 mcg/day). There is no evidence that exceeding the recommended dose is more effective.
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