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By C. Moff. Concordia College, Selma Alabama.

Example : The intensity of atomic absorption lines for the alkali metals purchase 400 mg ofloxacin mastercard, such as : potassium (K) ; rubidium (Rb) ; and caesium (Cs) purchase 200mg ofloxacin with visa, is found to be affected by temperature in a complex way cheap 400mg ofloxacin free shipping. Under certain experimental parameters a noticeable decrease in absorption may be observed in hotter flames ofloxacin 200mg without a prescription. Hence, lower excitation temperatures are invariably recommended for the analysis of alkali metals. Remedy : The resulting effects of shifts in ionization equilibrium may be eliminated effectively by the addition of an ionization suppressor, that promptly gives a comparatively high concentration of electrons to the flame. This ultimately results in the suppression of ionization by the respective analyte. Determination of both total zinc and zinc in solution is performed on a sample of the supernatant liquid obtained by centrifuging the suspension. The percentage of total zinc and of zinc in solution varies according to the strength of the preparation viz. Materials Required : Stock solution of Zn (5000 mcg ml–1) : Dissolve Zn metal (Anala-R-Grade) 2. Spray the solution by adopting the standard procedure and read off the concentration of zinc from a calibration curve prepared with solution containing 0. Heat, gently at first, then more strongly until all carbon is removed and a white ash is obtained. Allow to cool and add 5 ml of a mixture of nitric acid and hydrochloric acid and evaporate to dryness on a water-bath. Add 3 ml of hydrochloric acid, warm to dissolve and add sufficient water to produce 25 ml. Place in each of three similar graduated flasks equal volumes of the solution of the substance pre- pared as above. Add to all but one of these flasks a measured quantity of the specified standard solution of palladium to produce a series of solutions containing increases amounts of Pd. After calibrating the instrument as stated above, introduce each solution into the generator 3 times and record the steady reading at 248 nm. Plot the mean of the readings against concentration on a graph the axes of which intersect at zero added Pd and zero reading. Extrapolate the straight line joining the points until it meets the extrapolated concentration axis. The distance between this point and the intersection of the axes represents the concentration of Pd present in the prepared solution of carbenicillin sodium. How would you explain the mathematical expression derived from the total amount of light absorbed? How do the following three types of interferences affect the atomic absorption spectroscopic methods : (a) Spectral interferences, (b) Chemical interferences, and (c) Ionisation interferences. Discuss the assay of the following medicinal compounds in an elaborated manner : (i) Total Zn in insulin Zn suspension, (ii) Pd in carbenicillin sodium, (iii) Ag in cisplatin, (iv) Fe in Ascorbic acid, (v) Pb in Oxprenolol hydrochloride, and (vi) Ni in Prazosin hydrochloride. Sargent, ‘Atomic Absorption and Fluorescence Spectroscopy, New York, Academic Press, 1974. The normal-feasible separations which can thus be achieved are found to be rather easy, fast, convenient and effective resonably. Invariably such separations may be performed by shaking the two liquids in a separatory funnel for a few minutes ; and may be extended either to large quantities of pharmaceutical substances or trace levels. In the case of pharmaceutical chemicals that are mostly ‘organic solutes’, the liquid-liquid extraction system may very often make use of two immiscible organic solvents (e. On the contrary, the ‘inorganic solutes’ normally encountered are in- variably in aqueous solutions ; therefore, it has become absolutely necessary to produce such neutral sub- stances out of them, for instance ion-association complexes and metal-chelates (using organic-ligands) that may be extracted into an appropriate organic solvent. In short, liquid-liquid extraction has been employed predominantly and effectively not only for the pre-concentration and isolation of a ‘single’ chemical entity just before its actual estimation, but also for the extraction of classes of organic compounds or groups of metals, just prior to their usual estimation either by chromatographic techniques or by atomic-absorption methods. Now, if a third substance is made to dissolve in a two-phase mixture of the solvents (i. Therefore, under these prevailing experimental parameters the ratio of the mole fractions of the solute in the two respective immiscible phases (‘a’ and ‘b’) is found to be a constant which is absolutely independent of the quantity of solute present.

Pioglitazone binds extensively (> 99%) to protein in human serum discount 400mg ofloxacin free shipping, principally to serum albumin ofloxacin 400 mg fast delivery. Administration serum concentration (Cmin) for pioglitazone with food slightly delayed the time to peak serum and total pioglitazone increased proportionally concentration (to 3–4 hours) buy cheap ofloxacin 400mg line, but did not alter the at doses of 15 mg and 30 mg per day (Takeda extent of absorption 200 mg ofloxacin with visa. Most of the oral dose was excreted peak plasma concentrations of pioglitazone were into the bile either unchanged or as metabo- reported at 1 hour, and the plasma terminal half- lites, and eliminated in the faeces. Te distribu- ination of pioglitazone was negligible (Takeda tion of pioglitazone was not extensive; the tissue/ Pharmaceuticals, 2013). Serum concentrations of pioglitazone tion of rosiglitazone was relatively rapid, with and its active metabolites remained elevated 99% oral bioavailability afer oral absorption 24 hours afer exposure (Christensen et al. Peak plasma concentrations were observed (b) Metabolism about 1 hour afer single oral doses. No unchanged drug placental transfer of rosiglitazone was higher was eliminated in the urine. In a pharmacokinetics study of adminis- tration of rosiglitazone with food, absorption (b) Metabolism measured via Tmax was delayed by 1. Te major routes of metabolism were administration of rosiglitazone with food (Freed N-demethylation and hydroxylation, leading to et al. N-desmethyl-rosiglitazone and 3-hydroxy-ro- Te half-life values of rosiglitazone are similar siglitazone, followed by conjugation with sulfate in fasted and fed subjects (Bulliman et al. All the circulating metabo- Ethnicity had no impact on the pharmacoki- lites were considerably less potent than the parent netics of rosiglitazone among healthy subjects compound and, therefore, are not expected (Chu et al. Te administration of rosiglitazone (20 mg/kg bw per day for 8 weeks) to male Min 4. Treatment with rosiglitazone had or their metabolites in the urothelium, causing modest efects on levels of the transcription factor cancer due to a proliferation-driven chronic Egr-1 in the bladder urothelium. Certain zone plus fenofbrate expressed Egr-1 protein on metabolites of pioglitazone and rosiglitazone both the dorsal and ventral regions of the urinary have given positive results in the assay for gene bladder (Egerod et al. Tus, while perhaps not the primary decreases the amount of urinary solids and the mechanism, the contribution of genotoxicity extent of tumorigenesis in the urinary bladder. Since urothelial carcinogenesis is typically considered to be mediated by direct 4. Tis Te promoting activity of rosiglitazone in the occurs to a greater extent in rats than in mice, rat bladder has been attributed to an increased and in male rats than in female rats; these trends expression of Egr-1, ribosomal S6 protein phos- correspond to the greater susceptibility of rats phorylation, and c-Jun transcription factor compared with mice, and of male rats compared phosphorylation, which can lead to hypertrophy, with female rats, to the induction of urothelial hyperplasia, and subsequently urothelial-cancer tumours upon the administration of pioglitazone. Summary of Data Reported assessed in several studies, some with overlap- ping populations, from Europe, North America 5. Some subjects may have received both drugs (in sequence) at some time during treat- Tiazolidinediones are a unique class of ment for diabetes. In this trial, the most widely used oral drugs for the treatment Working Group noted the excess occurrence of of type 2 diabetes mellitus. Use of pioglitazone these cancers (14 in the treatment group versus hydrochloride has declined following studies 5 in the placebo group) within a short follow-up suggesting links to cancer of the bladder, heart time (11 of the bladder cancers occurred within failure, and bone fractures. Rosiglitazone maleate is approved in some Dose–response relationships were assessed countries for the treatment of type 2 diabetes in fve studies, three of which were high-quality mellitus. It is available both as a single agent and population-based studies (which adjusted for in combination with other oral medications for smoking or chronic obstructive pulmonary diabetes. Until 2007, rosiglitazone was among disease in the absence of data on smoking) the most widely used oral drugs for treatment conducted within the large health insurance of type 2 diabetes. No consistent pattern of increased risk relationship helped to mitigate concerns about was reported for any other specifc cancer site, or potential confounding by most risk factors; for all cancers combined for either drug. Administration of pioglitazone in the of disease in the populations studied as poten- feed caused a signifcant increase in the inci- dence of large intestine adenoma in one study tial explanations for positive associations with in genetically engineered male mice sensitive to pioglitazone. In a study in male and medical databases, which allowed for adjustment female neonatal mice, pioglitazone in the feed for potential confounding by medical factors, promoted mainstream cigarette smoke-induced but did not permit direct control for cigarette kidney adenoma in females. It also caused a signifcant positive trend in the Te potential for confounding by smoking is also incidence of subcutaneous lipoma in females. Furthermore, an excess of cancer of the bladder among pioglitozone users, and not cancer of the lung, was observed in the trial that randomized 5.

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Opportunities also exist to modernize and standardize industry’s approach to method validation and transfer buy ofloxacin 200mg on-line. By aligning method validation concepts and terminol- ogy with those used for process validation as well as equipment qualification ofloxacin 200mg overnight delivery, there is an opportunity to ensure that efforts in- vested in method validation are truly value adding cheap ofloxacin 400mg, rather than simply being a check-box exercise generic ofloxacin 400mg otc, and to reduce confusion and complexity for analytical scientists. A quality risk-management risks are assessed and mitigated throughout the product life- program systematically identifies and analyzes cycle. Risk assessment is especially critical when changes are the risks associated with a product or process, made to validated processes or systems to ensure the integ- mitigates those risks deemed unacceptable, and rity of the product is preserved as the risk profile evolves. Thus, an effective risk as- decision-making within a company regarding a sessment will ensure that maximal resources are directed product’s quality and provide greater assurance to a towards products, equipment, and processes deemed high company’s stakeholders of the ability to deliver the risk and minimal resources towards those deemed low risk. In this paper, the authors describe risk-assessment tools used in Less-formal tools for managing change control Risk management tools provide the necessary means by change control. It is, therefore, important to select the appropriate tool based on the objective and scope the assess- ment. The greater the risk and complexity of the system (or process) under review, the greater the level of formality and detail is required of the risk tool (see Figure 1). There are two primary goals in the assessment of risk when managing change: to assure that a company is not taking on 80 Pharmaceutical Technology OctOber 2012 PharmTech. These critical param- Current state Proposed state overall risk parameter rationale profile eters will serve as the input into the risk assessment process. Identify critical parameters for the system under re- into consideration the nature (i. Determine what the differences between the current The overall risk profile may be increased if the proposed and proposed states mean from a risk-based perspec- change increases variability, reduces reproducibility or ro- tive (i. Evaluate whether changes to overall risk profile are ac- versely, the exposure to overall risk may be reduced if the ceptable. Overall risk may remain following attributes as critical parameters: bioburden speci- the same if the change does not affect that particular critical fications, environmental exposure, vessel type, and vessel parameter or if it is proven or expected to be equivalent to 82 Pharmaceutical Technology OctOber 2012 PharmTech. Overall risk Acceptability Severity The risk associated with the critical parameter Minor Moderate Critical Low is acceptable. Medium High High The risk associated with the critical parameter may be acceptable provided additional actions are taken Medium (e. Additional risk control measures are Low Low Medium required to reduce risk to within an acceptable level. As with any risk assessment, available data To continue the hypothetical example in Table I, the overall should be cited as justification for the conclusions drawn. The critical parameter surrounding change is acceptable from a risk-based perspective. In general, the introduction of a new product-contact material, however, the proposed change is acceptable if the overall risk profile has increases risk and should be examined more thoroughly. If the overall risk profile, however, has increased for should be pursued, individual risks associated with the pro- the majority of critical parameters that were assessed, the pro- posed state (change) are not thoroughly explored through posed change should not be accepted until additional analyses this tool. These individual risks are best assessed through are conducted or risk mitigation measures are pursued. Ahunji Aoki, Hyogo University of Health Sciences, Japan Me and my Rotavapor Experience evaporation from the market leader The Rotavapor® System is a unique combination of cunning system configu- ration and trend-setting design. The benefits of working with the Rotavapor® System are: simple installation process, easy to use, time saving, sustainable, central process control and many more. Determine qualitative scales for insufficient Minor capacity (50L) likelihood and severity rankings. Identify critical parameters for the system under re- difficult to assign a likelihood score if there is no available view. Rank each potential failure for likelihood and severity tive approach and assign a likelihood score of “certain” to using the criteria established in Step 1.

Aloe vera may be used in cosmetics for For medicinal use ofAloe vera gel trusted ofloxacin 200 mg, 25 to 100 mL marketing reasons (i ofloxacin 200 mg discount. Te International Aloe Science Council a low level (Committee of Experts on Cosmetic recommended a total daily consumption of Aloe Products 400mg ofloxacin for sale, 2008) quality ofloxacin 200 mg. For topical use, application of a cosmetic formulation containing pure Aloe vera gel is ofen used liberally on the > 0. Regulatory author- (a) Production process ities in Germany have proposed that cosmetic products for which claims are made regarding Aloe vera grows best in dry chalky soil or in a Aloe vera should contain at least 5 g of Aloe vera sandy loam (Grindlay & Reynolds, 1986). Aloe vera whole leaf extract is obtained by Te quality of Aloe vera plant products varies grinding the whole fresh leaves, without removal considerably due to diferences in growing, of the rind. Extraneous material and lignifed harvesting, processing, and storage techniques fbres are then removed by homogenizing and (Boudreau et al. Aloe vera has become an important plant vera decolorized whole leaf extract is the frst crop in Arizona and in the Rio Grande valley of processing step where an extract is intention- southern Texas (Boudreau et al. Aloe vera Te production processes for Aloe vera prod- decolorized whole leaf has lower rheological ucts include various steps such as crushing, values than the gel and has a lower content of grinding or pressing, fltration, decoloriza- complex carbohydrates than either gel or whole tion, stabilization, heat processing, and may leaf extracts (Pelley et al. A complete overview of production stable, a problem that may cause diferences was provided by Ahlawat & Khatkar (2011). Te in product potency; therefore, the gel or whole technology for processing of Aloe vera gel was leaf extracts can undergo a stabilization process reviewed by Ramachandra & Rao (2008). Tis process may involve Harvesting of the leaves of the Aloe vera pasteurization, ultraviolet stabilization, chemical plant is generally performed by hand, with the oxidation with hydrogen peroxide, addition of leaves cut from the base of the plant (Grindlay & chemical preservatives and additives, or concen- Reynolds, 1986). At the processing list showing the relative frequency of use of plant step, the leaves may be cleaned with water and ingredients within formulations fled with the a mild chlorine solution (Grindlay & Reynolds, United States Food and Drug Administration 1986). Consumers of products specifed in Section In 2006, the industry size for Aloe species 1. Most products were reported as conducted by the National Health and Nutrition derived from Aloe vera (90%). Working Group from publicly available data; due to the small use, the coefcient of variation is > 30%, so that the data for Aloe vera are less reliable than for other herbs]. It can be assumed that workers ingredient containing anthraquinones at no in the production of Aloe vera may be exposed, more than 50 ppm (Committee of Experts on as well as workers in pharmaceutical, cosmetic, Cosmetic Products, 2008). Tis maximum level and food industries that use Aloe vera as an was also demanded in a safety assessment of the ingredient. Te doses topical applications of control cream or creams of whole leaf extract were equivalent to average containing: 3% or 6% (w/w) gel; 3% or 6% (w/w) daily doses of approximately 0, 2. Te minimal erythema dose is defned as the minimal amount of radiation that causes 3. Te mice were killed afer a recovery/ of 48 male and 48 female F344/N rats were observation period of 12 weeks. Te doses of whole experiment, 1 year, was too short to consider this leaf extract were equivalent to average daily arm of the experiment as a full carcinogenicity doses of approximately 0, 0. Survival of exposed the incidence of skin neoplasms in any groups groups was similar to that of controls. Te free aglycone is then absorbed, the absorption, distribution, metabolism, or undergoes oxidation, and is excreted in the excretion of topically applied Aloe vera gel, whole urine as rhein, as was shown in three volunteers leaf extract or decolorized whole leaf extract in receiving Aloe vera or barbaloin (Vyth & Kamp, experimental animals or humans. Aloe vera latex contains radiolabelled acemannan at a dose of 20 mg/kg the anthrone C-glycosides aloin A (barbaloin) body weight (bw) per day for 3 months resulted and aloin B (isobarbaloin) that are linked by in peak blood concentrations at 4–6 hours and β-glycosyl bonds to D-glucopyranose. Of the administered dose, 73% Intracaecal administration of [14C]rhein to was excreted in the urine, with > 60% occurring male Wistar rats resulted in 37% of the radioac- within 24 hours; 13% of the material was found tivity being excreted in the urine and 53% in the in the faeces. Te highest tissue concentrations were labelled acemannan was converted to substances found in the kidney (De Witte & Lemli, 1988). Tese were char- acterized as aloe-emodin, rhein, an unidentifed aglycone, and conjugates of these aglycones.

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