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PHR1397

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Fluocinolone Acetonide

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Fluocinolone acetonide, 6α,9α-Difluoro-11β,16α,17α,21-tetrahydroxy-1,4-pregnadiene-3,20-dione, 6α,9α-Difluoro-16α-hydroxyprednisolone 16,17-acetonide, 6α-Fluorotriamcinolone acetonide, Sinalar, Synandone
Empirical Formula (Hill Notation):
C24H30F2O6
CAS Number:
67-73-2
Molecular Weight:
452.49
EC Number:
200-668-5
MDL number:
MFCD00010525
UNSPSC Code:
41116107
PubChem Substance ID:
329823371
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to BP 160
traceable to Ph. Eur. F0200000
traceable to USP 1275009

API family

fluocinolone

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

267-269 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

CC1(C)O[C@@H]2C[C@H]3[C@@H]4C[C@H](F)C5=CC(=O)C=C[C@]5(C)[C@@]4(F)[C@@H](O)C[C@]3(C)[C@@]2(O1)C(=O)CO

InChI

1S/C24H30F2O6/c1-20(2)31-19-9-13-14-8-16(25)15-7-12(28)5-6-21(15,3)23(14,26)17(29)10-22(13,4)24(19,32-20)18(30)11-27/h5-7,13-14,16-17,19,27,29H,8-11H2,1-4H3/t13-,14-,16-,17-,19+,21-,22-,23-,24+/m0/s1

InChI key

FEBLZLNTKCEFIT-VSXGLTOVSA-N

Gene Information

human ... NR3C1(2908)

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General description

Fluocinolone Acetonide is a soluble potent steroid, approved for implantable corticosteroid devices named fluocinolone acetonide intravitreal implants for the treatment of chronic uveitis.
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

Fluocinolone Acetonide may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using differential-pulse polarography.
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 LRAA2173 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation mark
GHS07

Signal Word

Warning

Hazard Statements

H315,H319,H335

Hazard Classifications

Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3

Target Organs

Respiratory system

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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Determination of fluocinolone acetonide in pharmaceutical preparations by differential-pulse polarography
Leung PC and Tam KYS
Analyst, 106(1258), 100-104 (1981)
The
Surgical management of inflammatory eye disease (2008)
The
Profiles of Drug Substances Excipients and Related Methodology Acute and Chronic Complications of Diabetes An Issue of Endocrinology and Metabolism Clinics E Book, 42(1258) (2013)
Reply: To PMID 24875002.
Trucian A Ostheimer et al.
American journal of ophthalmology, 158(6), 1356-1356 (2014-12-03)
Mark Sanford
Drugs, 73(2), 187-193 (2013-01-22)
Fluocinolone acetonide intravitreal implant (Iluvien®) is an injectable, non-erodible, corticosteroid implant that is approved in several European countries for the treatment of chronic diabetic macular oedema (DMO). In analyses of two multinational trials in patients with DMO previously treated with
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