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
Metformin hydrochloride exists in a single stable crystalline form. There is one known polymorph of metformin hydrochloride, which exists only in a metastable state and hence is out of consideration of this formulation. C. Rationale: Selected dosage form is an extended release oral tablet.
LidoPro 4%-27.5%, Topical Analgesic, Quantity 121 Refills 0 Day's Supply 34,NDC # 53225102201
Compound 2 Commonly known as phlorizin. IUPAC name is 1-[2,4-dihydroxy-6-[(2S,3R,4R,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydropyran-2-yl]oxy-phenyl]-3-(4-hydroxyphenyl)propan-1-one was obtained as white to offwhite needle shaped crystals mp 1670C. The UV/Visible spectrum of the compound showed λmax at 226
Matthew Brayton Physics Measuring Lab Report: Purpose: To practice measuring, calculating uncertainty, and creating data tables. In this lab we measured 5 things - The surface area of the top of the one table, the volume of the room in square meters, the width of a single piece of paper, the length of my foot, and the circumference of my head. Data Table for the surface area of the top of one table: Length l /cm +/-
This drug treats breast, ovarian, pancreatic, lung, and bladder cancer. When cells are not working correctly in the body this causes a problem, the cells start to mutate and things start happening to the body, such as cancer. The chemical formula and structure for Gemzar. The chemical formula for Gemzar is C9H11F2N3O4. The chemical structure for Gemcitabine
Throughout the mixing process, the clear red solution slowly changes to a denser red solution (Appendix figure 23). A thermometer was used for temperature checking. The beaker was removed from the hot plate when the temperature was found to be higher than 50 ℃. This was done to prevent a sudden gelation happen before all the active dissolved in the ethylene glycol. Moderate heating of the solution for a period of time is allowed to obtain a wet gel (Appendix figure 24).
5.2. POVIDONE78, 79: Nonproprietary Names: BP: Povidone, USP: Povidone Synonyms: E1201; Kollidon; Plasdone; poly[1-(2-oxo-1-pyrrolidinyl)ethylene]; polyvidone; polyvinylpyrrolidone; PVP; 1-vinyl-2-pyrrolidinone polymer. Chemical Name and CAS Registry Number: 1-Ethenyl-2-pyrrolidinone homopolymer [9003-39-8] Empirical Formula and Molecular Weight: (C6H9NO)n 2500–3 000 000
Drugs produced in labs can have dosage forms changed quickly i.e. how the drug is delivered. For example, tablet or capsule form. 6.2.1 and 6.2.2 Penicillin An antibiotic in the penicillin group of drugs helps fight bacteria in the body.
RESULTS & DISCUSSIONS PREFORMULATION: S.NO API CHARACTERISATION RESULTS 1 Physical Appearance Mycophenolate mofetil white to off-white crystalline powder 2 Melting point 93-94ºC 3 solubility Freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. Table 3: Characterization of API Calibration Curve of Mycophenolate mofetil: Calibration Curve of Mycophenolate mofetil in pH 7.4 PBS Solvent pH 7.4 phosphate buffer Saline (PBS) Wave length 253 nm Unit for concentration mcg/mL Table 4: parameters for Calibration curve Table 5: Calibration data of Mycophenolate mofetil in pH 7.4 PBS S.NO Concentration (mcg/mL) Absorbance 1 0 0 2 2 0.185 3 4 0.345 4 6 0.526 5 8 0.722 6 10 0.907 Calibration Curve of Mycophenolate mofetil:
Liquisolid compacts: Means the formulation of immediate or sustained release dosage forms( tablets or capsules), formulated with addition of suitable excipient required for tabletting; like lubricants, binders or disintegrants.. 2. Liquisolid microsystem: Relies on a recent model which utilize same method used for formulation of liquisolid compacts combines with the addition of additives (e.g. poly vinyl pyrrolidone (PVP) in the non volatile liquid which is then incorporated into the carrier and coating materials to make a suitably flowing blend for encapsulation). Liquisolid microsystem offers advantage of that the size of the unit product may be reduced as much as 5 times lower than that of liquisolid systems and conventional products. Liquisolid systems (LS) may be classified into 3 subgroups, depending on the type of liquid medication that
Those compounds were selected for further modification as they combined excellent activity with an
Structure of Emtricitabine b) Chemical Name / IUPAC Name: 4-amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-1,2-dihydropyrimidin-2-one c) Molecular Formula: C8H10FN3O3S d) Molecular Weight: 247.248 g/mol e) Description: white to off-white crystalline solid f) Melting point: 136 °C to140 °C g) Solubility: Freely soluble in methanol and in water; practically insoluble in methylene chloride. h) pKa value: 2.65 i) Route of administration: Oral j) Excretion: Renal (86%) and fecal (14%) k) Metabolism: Hepatic oxidation and glucuronidation CYP system not involved l) Storage: Store at 25 °C (77 °F); excursions permitted to 15 °C-30 °C (59 °F-86 °F) m) Trade name: Emtriva, Truvada (a fixed-dose combination with Tenofovir),
1.Introduction: Ox diazole, a heterocycles nucleus has attracted a wide attention of the chemist in search for new therapeutic molecules. Five member heterocycles compounds show various type of biological activities among than 2,5-distributed 1,3,4-ox diazole are associated with diverse biological activities [2]. Various biological activities like antimicrobial, anti-tubercular, anti-inflammatory, Anticonvulsant [3], Hypnotic , Anesthetic activity [4]. 1,3,4-ox diazole showed antibacterial properties similar to those of well known sulfonamide drugs. The ox diazole nucleus with N=C-S linkage exhibits a large number of pharmacological activities [5].
% Drug content of all the formulations was determined and was found to have a range of 98-100% when UV-Spectrophotometer is used. This shows that drug was dispersed homogenously throughout the gels. The drug content for F13 formulation was found to be higher because of the optimum ethanol concentration. Rheological Studies of the
Zn Wt. % 90.7 – 94.7 Max 0.1 3.8 – 4.9 Max 0.5 1.2 – 1.8 0.3 – 0.9 Max 0.05 Max 0.15 Max 0.5 Max 0.15 Max 0.25 Table - 3: Composition of Al2024 Properties for Al2024: