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PHR1702

Fluticasone Propionate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Fluticasone propionate, (6α,11β,16α,17α)-6,9-Difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid S-(fluoromethyl) ester

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About This Item

Empirical Formula (Hill Notation):
C25H31F3O5S
CAS Number:
80474-14-2
Molecular Weight:
500.57
NACRES:
NA.24
PubChem Substance ID:
329823565
UNSPSC Code:
41116107
MDL number:
MFCD00866007
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Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0000284, traceable to USP 1285873

API family

fluticasone

CofA

current certificate can be downloaded

packaging

pkg of 200 mg

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

CCC(=O)O[C@@]1([C@H](C)C[C@H]2[C@@H]3C[C@H](F)C4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@]12C)C(=O)SCF

InChI

1S/C25H31F3O5S/c1-5-20(31)33-25(21(32)34-12-26)13(2)8-15-16-10-18(27)17-9-14(29)6-7-22(17,3)24(16,28)19(30)11-23(15,25)4/h6-7,9,13,15-16,18-19,30H,5,8,10-12H2,1-4H3/t13-,15+,16+,18+,19+,22+,23+,24+,25+/m1/s1

InChI key

WMWTYOKRWGGJOA-CENSZEJFSA-N

Gene Information

human ... NR3C1(2908)

General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Fluticasone Propionate, a neutral, highly potent trifluorinated corticosteroid, is a component of aqueous nasal sprays. It shows potent topical anti-inflammatory activity and is highly efficient in suppressing the nasal symptoms associated with rhinitis and asthma.

Application

Fluticasone Propionate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and plasma samples by various chromatography techniques.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

Fluticasone propionate is a second generation glucocorticoid. Used as an anti-inflammatory agent for asthma. Shown to enhance eosinophil apoptosis in a concentration-dependent manner via the glucocorticoid receptor.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.
To see an example of a Certificate of Analysis for this material enter LRAB9941 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

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pictograms

Health hazard
GHS08

signalword

Warning

Hazard Classifications

Repr. 2 - STOT RE 2

target_organs

Endocrine system

Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

涉药品监管产品

This item has

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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HPTLC-densitometric method for simultaneous determination of salmeterol xinafoate and fluticasone propionate in dry powder inhalers.
Kasaye L, et al.
Saudi Pharmaceutical Journal : SPJ : The Official Publication of the Saudi Pharmaceutical Society, 18(3), 153-159 (2003)
Validation of a stability indicating reversed phase LC method for the determination of fluticasone propionate in pharmaceutical formulations.
Sangoi MDS, et al.
Journal of Liquid Chromatography and Related Technologies, 31(14), 2113-2127 (2008)
A rapid and sensitive HPLC?APCI-MS/MS method determination of fluticasone in human plasma: Application for a bioequivalency study in nasal spray formulations.
Byrro RMD, et al.
Journal of Pharmaceutical and Biomedical Analysis, 61(5), 38-43 (2012)
View All Related Papers

Global Trade Item Number

SKUGTIN
PHR1702-200MG04061834801825