Historical incidents leading to the evolution of good manufacturing practice

The concept of good manufacturing practice (GMP) is not new; its roots are very old. The incidents that gave birth to the concept of GMP are summarized in this article. The journey from the FDA toward GMP is highlighted in chronological order. These regulations are mandatory for pharmaceutical industries in order to manufacture quality products.     

Enoxacin trihydrate

The structure of the title compound, 1‐ethyl‐6‐fluoro‐1,4‐di­hydro‐4‐oxo‐7‐(piperazin‐4‐ium‐1‐yl)‐1,8‐naphthyridine‐3‐carb­oxylate trihydrate, C₁₅H₁₇FN₄O₃·3H₂O, has a zwitterion of enoxacin and three water mol­ecules in the asymmetric unit. The zwitterions form sheets lying parallel to each other and are hydrogen bonded in a head‐to‐tail manner. The crystal structure is stabilized by the involvement of O and H atoms from all the water mol­ecules in strong hydrogen bonds. The naphthyridine ring system is essentially planar, with the carboxyl­ate group lying out of this plane at an angle of 26.13 (6)° and the ethyl group oriented at approximately right angles to this plane. The piperazinium ring adopts a chair conformation.     

A novel daucosterol derivative and antibacterial activity of compounds from Arctotis arctotoides

Arctotis arctotoides is a perennial herb used medicinally for the treatment of various ailments in the Eastern Cape, South Africa. Different extracts of the plant were investigated for their antimicrobial constituents. This led to the isolation and identification of a new daucosterol derivative 3-O-[beta-D-(6'-nonadeanoate)glucopyranosyl]-beta-sitosterol and seven known compounds namely: serratagenic acid, stigmasterol, daucosterol, zaluzanin D, dehydrocostuslactone, nepetin, and pedalitin. The structures of the compounds were elucidated on the basis of spectral analysis, including homo and hetero nuclear correlation NMR experiments (COSY, NOESY, HMQC, HMBC) and mass spectra as well as by comparison with available data in the literature. The compounds exhibited antibacterial activity except stigmasterol, daucosterol and dehydrocostuslactone. Nepetin was the most active against Bacillus subtilis and Staphylococcus aureus with the minimum inhibitory concentrations of 4 microg mL( - 1) and 31 microg mL( - 1), respectively, while others exhibited moderate activity.     

A new triterpenoid from roots of Laportea crenulata and its antifungal activity

A new triterpenoid 2alpha,3beta,21beta,23,28-penta hydroxyl 12-oleanene and two known compounds were isolated from the roots of Laportea crenulata Gaud. The structures of all compounds were elucidated on the basis of various spectroscopic data. The two known compounds beta-sitosterol and beta-sitosterol 3-beta-D-glucopyranoside are also the first report of isolation from this plant. The antifungal activity of new triterpenoid was studied against Aspergillus flavus, Aspergillus niger, Candida albicans, and Rhizopus aurizae, and compared with the activity of nystatin (30 microg disc(-1)). This compound has shown moderate activity against tested fungi.     

ON POINTWISE R-SUBWEAKLY COMMUTING MAPS AND BEST APPROXIMATIONS

The main purpose of this paper is to prove some common fixed point theorems for pointwise R-subweakly commuting maps on non-starshaped domains in p-normed spaces and locally convex topological vector spaces. As applications, invariant approximation results are established. This work provides extension as well as substantial improvement of several results in the existing literature.     

On pointwise <Emphasis Type="Italic">R</Emphasis>-subweakly commuting maps and best approximations

The main purpose of this paper is to prove some common fixed point theorems for pointwise R-subweakly commuting maps on non-starshaped domains in P-normed spaces and locally convex topological vector spaces.As applications,invariant approximation results ale established.This work provides extension as well as substantial improvement of several results in the existing literature.     

Anomalous Distribution Behavior of Radioiodine at Tracer Concentrations

The solvent extraction behavior of radioiodine at tracer concentration was studied by varying the pH of the tracer solution in order to gain deeper insight into the anomalous behavior of radioiodine at low concentrations. The anomalous behavior of radioiodine was observed with all the tracer solutions because of the existence of radioiodine complex in the tracer solution. The observed anomalous behavior of radioiodine was consistently explained by the comprehensive extraction mechanism.     

An approach to voice conversion using feature statistical mapping

The voice conversion (VC) technique recently has emerged as a new branch of speech synthesis dealing with speaker identity. In this work, a linear prediction (LP) analysis is carried out on speech signals to obtain acoustical parameters related to speaker identity - the speech fundamental frequency, or pitch, voicing decision, signal energy, and vocal tract parameters. Once these parameters are established for two different speakers designated as source and target speakers, statistical mapping functions can then be applied to modify the established parameters. The mapping functions are derived from these parameters in such a way that the source parameters resemble those of the target. Finally, the modified parameters are used to produce the new speech signal. To illustrate the feasibility of the proposed approach, a simple to use voice conversion software has been developed. This VC technique has shown satisfactory results. The synthesized speech signal virtually matching that of the target speaker.     

Simultaneous determination of clopidogrel and aspirin by RP-HPLC from bulk material and dosage formulations using multivariate calibration technique

A rapid, simple, and easy method for the simultaneous determination of clopidogrel and aspirin from bulk material and dosage formulations in the presence of meloxicam as internal standard has been developed. Separation was carried out on a Purospher star C(18) (5 μm, 250 × 4.6 mm) column at ambient temperature. The mobile phase consisted of methanol-water (80:20, v/v), the pH of the mobile phase was adjusted to 3.4 with ortho-phosphoric acid and pumped at a flow rate of 1 mL/min using isocratic pump system. Multivariate chromatographic calibration technique was subjected to high-performance liquid chromatography (HPLC) data for simultaneous quantitative analysis of binary mixtures of clopidogrel and aspirin. HPLC data based on the analyte peak areas were obtained at five wavelengths (225, 230, 235, 240, and 245 nm). The mathematical algorithm of multivariate chromatographic calibration technique is based on the use of the linear regression equations. Calibration plots for clopidogrel and aspirin were constructed at each wavelength by using the peak areas corresponding to the concentrations of each active compound. This multivariate chromatographic method was also applied to a commercial pharmaceutical dosage form containing clopidogrel and aspirin.