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PHR1702

Supelco

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
MDL number:
MFCD00866007
UNSPSC Code:
41116107
PubChem Substance ID:
329823565
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

agency

traceable to BP 587
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)

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Related Categories

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, EP and BP 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.

Footnote

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.

related product

Product No.
Description
Pricing

1285873

Fluticasone propionate, United States Pharmacopeia (USP) Reference Standard

Y0000284

Fluticasone propionate, European Pharmacopoeia (EP) Reference Standard

Y0000221

Fluticasone impurity D, European Pharmacopoeia (EP) Reference Standard

1285884

Fluticasone Propionate Resolution Mixture, United States Pharmacopeia (USP) Reference Standard

1285895

Fluticasone Propionate System Suitability Mixture, United States Pharmacopeia (USP) Reference Standard

1285840

Fluticasone Propionate Related Compounds Mixture, United States Pharmacopeia (USP) Reference Standard

1285910

Fluticasone Propionate Nasal Spray Resolution Mixture, United States Pharmacopeia (USP) Reference Standard

Y0001754

Fluticasone propionate for impurity C identification, European Pharmacopoeia (EP) Reference Standard

1285829

Fluticasone propionate Related Compound D, United States Pharmacopeia (USP) Reference Standard

1285818

Fluticasone propionate Related Compound J, United States Pharmacopeia (USP) Reference Standard

PHR1844

Fluticasone Related Compound D, Pharmaceutical Secondary Standard; Certified Reference Material

PHR1842

Fluticasone Related Compound A, Pharmaceutical Secondary Standard; Certified Reference Material

PHR1846

Fluticasone Related Compound J, Pharmaceutical Secondary Standard; Certified Reference Material

BP587

Fluticasone propionate, British Pharmacopoeia (BP) Reference Standard

BP588

Fluticasone S-methyl impurity, British Pharmacopoeia (BP) Reference Standard

Y0002249

Fluticasone propionate for system suitability, CRS, European Pharmacopoeia (EP) Reference Standard

PHR2270

Fluticasone Propionate Impurity A, certified reference material, pharmaceutical secondary standard

pictograms

Health hazard
GHS08

signalword

Warning

Hazard Classifications

Repr. 2 - STOT RE 2

target_organs

Endocrine system

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAC8038
LRAB5523
LRAB9941
LRAA6968

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If you require a particular version, you can look up a specific certificate by the Lot or Batch number.

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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)
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)
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)
Oil-in-water microemulsion high performance liquid chromatographic analysis of pharmaceuticals.
Marsh A, et al.
Chromatographia, 59(9), 531-542 (2004)
Nunzio Vicario et al.
International journal of molecular sciences, 20(8) (2019-04-26)
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