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Nome Químico: 2-((2S,6aS,6bS,7aS,8aS,8bS,11aR,12aS,12bS)-2-fluoro-6a,8a,10,10-tetramethyl-4-oxo-1,4,6a,7a,8,8a,11a,12,12a,12b-decahydronaphtho[2',1':4,5]oxireno[2',3':5,6]indeno[1,2-d][1,3]dioxol-8b(2H)-yl)-2-oxoethyl acetate
Shipping Temperature: Ambient
HSN Code: 38229010
Country of Origin: India
Sorrisos: C[C@@](C1=CC2=O)(C=C2)[C@@]3([C@](C[C@@H]1F)([H])[C@@](C[C@](O4)([H])[C@]5(OC4(C)C)C(COC(C)=O)=O)([H])[C@]65C)[C@@](C6)([H])O3
Fluocinonide Impurity 1 is chemically 2-((2S,6aS,6bS,7aS,8aS,8bS,11aR,12aS,12bS)-2-fluoro-6a,8a,10,10-tetramethyl-4-oxo-1,4,6a,7a,8,8a,11a,12,12a,12b-decahydronaphtho[2',1':4,5]oxireno[2',3':5,6]indeno[1,2-d][1,3]dioxol-8b(2H)-yl)-2-oxoethyl acetate. Fluocinonide Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Fluocinonide Impurity 1 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Fluocinonide.
The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.
Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products
Rong-Kun Chang,1 Andre Raw,1,2 Robert Lionberger,1 and Lawrence Yu1
AAPS J. 2013 Jan; 15(1): 41–52.
A Validated Stability-Indicating LC Method for Fluocinonide in the Presence of Degradation Products, Its Process-Related Impurities and Identification of Degradation Products
Prabha Srinivasu1,2, Devarakonda V. SubbaRao1, Raju V. K. Vegesna1, K. Sudhakar Babu
American Journal of Analytical Chemistry, 2010, 1, 113-126
Review article impurity profiling of drugs towards safety and efficacy: theory and practice
kiran r. dhangar, rakesh b. jagtap, sanjay j. surana and atul a. shirkhedkar
J. Chil. Chem. Soc., 62, Nº 2 (2017)
The determination of fluocinolone acetonide in formulated products
F. BAILEY, A. HOLBROOK AND R. J. MILLER
J. Pharm. Phavmac., 1966, 18, Suppl., 12s-16s
