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Chemical Name: [1R-[1α(2S*,5R*),2β,5α]]-5-(4-Amino-5-fluoro-2-oxo-1(2H)-pyrimidinyl)-1,3-oxathiolane-2-carboxylic Acid 5-Methyl-2-(1-methylethyl)cyclohexyl Ester
Shipping Temperature: Ambient
HSN Code: 38229010
Country of Origin: India
Smiles: O=C([C@H]1O[C@@H](N2C=C(F)C(N)=NC2=O)CS1)O[C@H]3[C@H](C(C)C)CC[C@@H](C)C3
Emtricitabine Impurity 15 is chemically [1R-[1α(2S*,5R*),2β,5α]]-5-(4-Amino-5-fluoro-2-oxo-1(2H)-pyrimidinyl)-1,3-oxathiolane-2-carboxylic Acid 5-Methyl-2-(1-methylethyl)cyclohexyl Ester. Emtricitabine Impurity 15 is supplied with detailed characterization data compliant with regulatory guideline. Emtricitabine Impurity 15 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 Emtricitabine.
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.
Analytical method validation for content of emtricitabine and tenofovir in emtricitabine and tenofovir tablet formulation by RP-HPLC
By Sekar, V.; Devi, V.; Sambath, Kumar R.
From World Journal of Pharmacy and Pharmaceutical Sciences (2021), 10(4), 1336-1345
Stability-indicating high-performance thin-layer chromatography method for the simultaneous estimation of emtricitabine and tenofovir alafenamide fumarate
By Kashid, Arun M.; Kadam, Rohini R.
From Journal of Planar Chromatography--Modern TLC (2021), Ahead of Print.
Stability indicating method development and validation for simultaneous estimation of emtricitabine and tenofovir disoproxil fumarate in bulk and tablet dosage form by RP-HPLC
By Jyothsna, Modugula; Seshagiri, Podili Venkata
From World Journal of Pharmaceutical Research (2019), 8(5), 1028-1046