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PHR1842

Supelco

Fluticasone Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
6ALPHA,9-DIFLUORO-11BETA-HYDROXY- 16ALPHA-METHYL-3-OXO-17 (PROPANOYLOXY)ANDROSTA-1,4-DIEN- 17BETA-CARBO(THIOPEROXOIC)SO-ACID (Fluticasone Related Compound A) (Fluticasone Impurity B), 6ALPHA,9-DIFLUORO-11BETA-HYDROXY- 16ALPHA-METHYL-3-OXO-17 (PROPANOYLOXY)ANDROSTA-1,4-DIEN- 17BETA-CARBO(THIOPEROXOIC)SO-ACID
Empirical Formula (Hill Notation):
C24H30F2O6S
CAS Number:
Molecular Weight:
484.55
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

API family

fluticasone

CofA

current certificate can be downloaded

packaging

pkg of 50 mg

application(s)

pharmaceutical small molecule

format

neat

storage temp.

2-8°C

General description

Fluticasone Related Compound B is an impurity of the synthetic corticosteroid drug, fluticasone propionate. Fluticasone propionate is generally used as an inhalation medication for the treatment of asthma.
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.

Application

Fluticasone Related Compound B may be used as a pharmaceutical reference standard for the determination of the analyte in bulk drug and pharmaceutical formulations by high performance liquid chromatography.
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.

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 LRAB2754 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

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Description
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Pictograms

Health hazard

Signal Word

Danger

Hazard Statements

Hazard Classifications

Resp. Sens. 1 - Skin Sens. 1

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

监管及禁止进口产品

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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Comparative evaluation of the leukotriene receptor antagonist pranlukast versus the steroid inhalant fluticasone in the therapy of aged patients with mild bronchial asthma
Horiguchi T, et al.
Arzneimittelforschung, 57(02), 87-91 (2007)
Fluticasone propionate
USP42/NF37: United States Pharmacopeia and National Formulary
United States Pharmacopeia/National Formulary, 32(2), 1940-1940 (2014)

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