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Key Documents

PHR1397

Supelco

Fluocinolone Acetonide

Pharmaceutical Secondary Standard; Certified Reference Material

동의어(들):

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

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About This Item

실험식(Hill 표기법):
C24H30F2O6
CAS Number:
Molecular Weight:
452.49
EC Number:
MDL number:
UNSPSC 코드:
41116107
PubChem Substance ID:
NACRES:
NA.24

Grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

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

API family

fluocinolone

CofA

current certificate can be downloaded

기술

HPLC: suitable
gas chromatography (GC): suitable

mp

267-269 °C (lit.)

응용 분야

pharmaceutical (small molecule)

형식

neat

저장 온도

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

유전자 정보

human ... NR3C1(2908)

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일반 설명

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.

애플리케이션

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.

분석 메모

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

기타 정보

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.

각주

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.

픽토그램

Exclamation mark

신호어

Warning

유해 및 위험 성명서

Hazard Classifications

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

표적 기관

Respiratory system

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point (°F)

Not applicable

Flash Point (°C)

Not applicable


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시험 성적서(COA)

Lot/Batch Number

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문서 라이브러리 방문

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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