Trigonometry Lab Report

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S. DRUG SUBSTANCE S1. General Information S1.1 Nomenclature Table 84 Nomenclature of Drug Substance International Nonproprietary Name (INN) Levofloxacin Hemihydrate Chemical Name 7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-hydrate (2:1), (S)-.(-)-(S)-9-Fluoro-2,3-dihydro-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7Hpyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, hemihydrates Generic name Levofloxacin Hemihydrate CAS Number [138199-71-0] S1.2 Structure and attachment for structure of drug substance Table 85 Structure of Drug Substance Structural Formula : C18H20FN3O4 •½ H2O Relative Molecular Mass : 370.38 Structural Formula : S1.3…show more content…
The reaction mixture is condensed under reduced pressure concentration. Then the reaction mixture is filtered in the presence of chloroform and charcoal. • Neutralization and extraction step is done by mixing reaction mixture with Hydrochloric acid, Sodium hydroxide in drinking water and chloroform followed by dissolution and crystallization to form Crude Levofloxacin. • Crude Levofloxacin is decolorized by ethanol and charcoal which is then recrystallized and centrifuged to form Levofloxacin (Intermediate). Stage III: Preparation of Levofloxacin Levofloxacin (Intermediate) undergoes dissolution and decoloration in presence of ethanol and charcoal followed by recrystallization and centrifugation to form Levofloxacin. Stage IV: Drying and Packaging The final product is dried, crushed and analyzed followed by inner packaging and outer packaging. Fig. 18 The chemical synthetic route from Levofloxacin and ethyl ester (i.e. starting material to Levofloxacin…show more content…
NO 2565 MFG. DATE: MM/YYYY MANUFACTURED BY: XYZ PHARMACEUTICALS LTD Sr. No. Test Observation Limit C015-1004001 C015-1004002 C015-1004003 01 Description Conform Conform Conform Light yellowish-white to yellow-white crystal or crystalline powder 02 Identification (A) IR (B) HPLC Conform Conform Conform Conform Conform Conform (A) Conform to standard spectrum (B) Conform to Standard peak 03 Specific rotation -100° -101° -101° -92° to 106° 04 Water 2.4% 2.5% 2.4% 2.1% to 2.7% 05 Residue on ignition 0.02% 0.02% 0.02% NMT 0.2% 06 Heavy metals Conform Conform Conform NMT 10ppm 07 Impurities Impurity a 0.03% 0.03% 0.04% NMT 0.3% Impurity b 0.01% 0.02% 0.03% NMT 0.3% Impurity c 0.04% 0.04% 0.04% NMT 0.3% Impurity d ND ND ND NMT 0.3% Impurity e 0.06% 0.06% 0.06% NMT 0.8% Unknown impurity 0.02% 0.02% 0.02% NMT 0.1% Total impurity (except impurity e) 0.11% 0.12% 0.14% NMT 0.5% 08 Residual Solvent Methanol Ethanol Chloroform 0.0008% 0.04% ND 0.0006% 0.03% ND 0.0005% 0.02% 0.14% NMT 0.1% NMT 0.3% NMT 0.006% 09 Assay 100.8% 100.3% 100.5% 98.5% to 102.0% S4.5. Justification of

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