Interlaboratory comparison of analytical methods for residual ethylene oxide at low concentration levels in medical device materials.


:An interlaboratory comparison of two extraction methods and one thermal desorption test method for the quantification of ethylene oxide (EO) by gas chromatography in two common medical device materials, high density polyethylene (HDPE) and plasticized polyvinyl chloride (PVC), was conducted by 15 laboratories. The three procedures included extraction with water, extraction with acetone, and headspace gas analysis, respectively. Materials were processed through an industrial EO cycle and aerated for various periods to achieve target levels of a low (5 micrograms/g), medium (10 micrograms/g), and high (25 micrograms/g) residual determination following extraction or thermal desorption. The results of this study, using only the data from the laboratories that did not deviate from the procedure, showed that the average estimated total coefficient of variation ranged from 3.63 to 12.42% for the three different methods. Each of the methods is suitable for use as a reference test method for determining residual EO in polymeric materials in the concentration range 2.8-42.3 micrograms/g.


J Pharm Sci


Lao NT,Lu HT,Rego A,Kosakowski RH,Burgess DJ,Hume RD




Has Abstract


1995-05-01 00:00:00














  • Effect of Controlled Ice Nucleation on Stability of Lactate Dehydrogenase During Freeze-Drying.

    abstract::Several controlled ice nucleation techniques have been developed to increase the efficiency of the freeze-drying process as well as to improve the quality of pharmaceutical products. Owing to the reduction in ice surface area, these techniques have the potential to reduce the degradation of proteins labile during free...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Fang R,Tanaka K,Mudhivarthi V,Bogner RH,Pikal MJ

    更新日期:2018-03-01 00:00:00

  • Comparative pharmacokinetics of butylated hydroxyanisole and butylated hydroxytoluene in rabbits.

    abstract::The widespread use of butylated hydroxyanisole (I) and butylated hydroxytoluene (II) as food antioxidants recently has been criticized by the Food and Drug Administration because of their pharmacological and toxicological effects. Interest also has arisen recently in the use of these compounds as anticancer agents. Th...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: El-Rashidy R,Niazi S

    更新日期:1980-12-01 00:00:00

  • In vitro and in vivo safety evaluation of biodegradable self-assembled monomethyl poly (ethylene glycol)-poly (ε-caprolactone)-poly (trimethylene carbonate) micelles.

    abstract::Safety evaluation of self-assembled polymeric micelles is important for biomedical involvement in drug delivery systems in the future. In this study, biodegradable monomethyl poly (ethylene glycol)-poly (ε-caprolactone)-poly (trimethylene carbonate) [MPEG-P(CL-co-TMC)] copolymer was synthesized and characterized by Fo...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Yang X,Cao D,Wang N,Sun L,Li L,Nie S,Wu Q,Liu X,Yi C,Gong C

    更新日期:2014-01-01 00:00:00

  • Simultaneously manufactured nano-in-micro (SIMANIM) particles for dry-powder modified-release delivery of antibodies.

    abstract::Simultaneously Manufactured Nano-In-Micro (SIMANIM) particles for the pulmonary delivery of antibodies have been prepared by the spray-drying of a double-emulsion containing human IgG (as a model antibody), lactose, poly(lactide-co-glycolide) (PLGA) and dipalmitoylphosphatidylcholine (DPPC). The one-step drying proces...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Kaye RS,Purewal TS,Alpar HO

    更新日期:2009-11-01 00:00:00

  • Prostaglandin prodrugs VI: structure-thermodynamic activity and structure-aqueous solubility relationships.

    abstract::Solubilities in isoctane and water were determined for several C1-phenolic esters of prostaglandin F2 alpha and prostaglandin E2 and acetates having the same phenol moiety. Linear free energy relationships for solubility among the series were observed with slopes of approximately 1. These results suggest that the cont...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Anderson BD,Conradi RA

    更新日期:1980-04-01 00:00:00

  • Design and evaluation of sustained-release tablets of lithium in a fat matrix and its bioavailability in humans.

    abstract::The development of sustained-release lithium (Li) tablets, intended to release the active principle at a rate of 1.0 mM/h for 10 h, was undertaken. The parameters used for the control of the release were the glyceril palmite-stearate content, the carboxypolymethylene content, and the compression force. The experimenta...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Llabrés M,Fariña JB

    更新日期:1991-11-01 00:00:00

  • Prediction of onset of crystallization from experimental relaxation times. II. Comparison between predicted and experimental onset times.

    abstract:UNLABELLED:Given a good correlation between onsets of crystallization and mobility above T(g), one might be able to predict crystallization onsets at a temperature of interest far below T(g) from this correlation and measurement of mobility at a temperature below T(g). Such predictions require that: (a) correlation bet...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Bhugra C,Shmeis R,Krill SL,Pikal MJ

    更新日期:2008-01-01 00:00:00

  • Enhancement of solubility of drug salts by hydrophilic counterions: properties of organic salts of an antimalarial drug.

    abstract::Judicious choice of the salt form of a drug can greatly affect the aqueous solubility and formulation of the compound. The objective of this work was to demonstrate the effect of various counteranions on the aqueous solubility of the antimalarial agent alpha-(2-piperidyl)-3, 6-bis(trifluoromethyl)-9-phenanthrenemethan...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Agharkar S,Lindenbaum S,Higuchi T

    更新日期:1976-05-01 00:00:00

  • Synthesis and cytotoxic evaluation of some cyclic arylidene ketones and related oximes, oxime esters, and analogs.

    abstract::A number of arylidene derivatives of alicyclic ketones and some corresponding oximes, oxime esters, and related compounds were prepared as candidate cytotoxic agents. All of the compounds were evaluated against murine L1210 lymphoid leukemia cells. In general, cytotoxicity was greatest with the alpha,beta-unsaturated ...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Dimmock JR,Sidhu KK,Chen M,Li J,Quail JW,Allen TM,Kao GY

    更新日期:1994-06-01 00:00:00

  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Proguanil Hydrochloride.

    abstract::Literature data relevant to the decision to waive in vivo bioequivalence testing for the approval of generic immediate release solid oral dosage forms of proguanil hydrochloride are reviewed. To elucidate the Biopharmaceutics Classification System (BCS) classification, experimental solubility and dissolution studies w...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章,评审


    authors: Plöger GF,Abrahamsson B,Cristofoletti R,Groot DW,Langguth P,Mehta MU,Parr A,Polli JE,Shah VP,Tajiri T,Dressman JB

    更新日期:2018-07-01 00:00:00

  • Identification of the major degradation products of 4-methoxy-2-(3-phenyl-2-propynyl)phenol formed by exposure to air and light.

    abstract::Exposure of 4-methoxy-2-(3-phenyl-2-propynyl)phenol (CO/1828) to air and light (accelerated by temperature) yields 1-(2-hydroxy-5- methoxyphenyl)-3-phenylpropynone as the major degradation product. With extraction, this product rapidly degrades to 5-methoxyaurone and 6-methoxyflavone. In addition, a mixture of dimeric...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Schiavi M,Serafini S,Italia A,Villa M,Fronza G,Selva A

    更新日期:1992-08-01 00:00:00

  • Segmental difference and effect of glucose on drug exsorption across the small intestine of rats.

    abstract::An exsorption technique which can assess the transport of a drug from blood to the intestinal lumen was used to study the effects of glucose and to determine the presence of segmental differences in drug transport across the rat small intestinal membrane following intravenous drug administration. The drugs used in the...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Johno I,Kitazawa S

    更新日期:1985-03-01 00:00:00

  • Ditiocarb: decomposition in aqueous solution and effect of the volatile product on its pharmacological use.

    abstract::The kinetic profile for the decomposition of ditiocarb sodium salt in aqueous solution was achieved with UV-visible absorption spectrometry. The kinetic profile indicates that the decomposition reaction is hydrogen ion-catalyzed over the entire 4-10 pH range and enables the determination of the value of the acid-base ...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Martens T,Langevin-Bermond D,Fleury MB

    更新日期:1993-04-01 00:00:00

  • Limits on optimizing ocular drug delivery.

    abstract::The problem of optimizing ocular bioavailability of topically applied ophthalmic drugs is discussed. A formula for drug concentration in the tear film is derived using well-known pharmacokinetic relationships and a first-order drug decay model for the tear film. The time integral of the tear film concentration is then...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Keister JC,Cooper ER,Missel PJ,Lang JC,Hager DF

    更新日期:1991-01-01 00:00:00

  • Effects of reducing sugars on the chemical stability of human relaxin in the lyophilized state.

    abstract::Sugars and polyols have been used routinely with lyophilized proteins and peptides as bulking agents, cryoprotectants, and lyoprotectants. However, reducing sugars may present a problem as excipients since they are potentially reactive with proteins. In this stability study of recombinant human relaxin (Rix) with vari...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Li S,Patapoff TW,Overcashier D,Hsu C,Nguyen TH,Borchardt RT

    更新日期:1996-08-01 00:00:00

  • Micro and macro GLC determination of ethambutol in biological fluids.

    abstract::Previously available GLC methods for ethambutol may only be used to measure quantities of drugs much greater than those found in biological fluids such as plasma and dialysate. A previously published GLC method for plasma samples is extended to measure ethambutol in dialysate. A second GLC method, involving derivatiza...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Lee CS,Benet LZ

    更新日期:1978-04-01 00:00:00

  • Unified model for the corneal permeability of related and diverse compounds with respect to their physicochemical properties.

    abstract::Corneal permeability data taken from the literature were analyzed for possible quantitative relationships with physicochemical properties. Although a parabolic relationship was obtained with good correlation between lipophilicity, as expressed by the 1-octanol-water partition coefficients, log Poctanol (or the distrib...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Yoshida F,Topliss JG

    更新日期:1996-08-01 00:00:00

  • Total deposition of therapeutic particles during spontaneous and controlled inhalations.

    abstract::Treatment of systemic diseases by means of the inhalation route is hampered by uncertainties of the drug dose applied by inhalation. In this study, the hypothesis was tested that by standardization of the breathing maneuver used for inhalation, the interindividual variability of the dose deposited intrathoracically ca...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Brand P,Friemel I,Meyer T,Schulz H,Heyder J,Häubetainger K

    更新日期:2000-06-01 00:00:00

  • Synthesis and preliminary pharmacology of an internal standard for assay of neostigmine.

    abstract::The synthesis of the diethyl analog of neostigmine, its preliminary pharmacology, and its use as an internal standard for the GLC assay of neostigmine are described. Both the diethyl analog and neostigmine undergo thermal demethylation in the injection port. The column selected produced satisfactory resolution and sho...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Ward HE Jr,Freeman JJ,Sowell JW,Kosh JW

    更新日期:1981-04-01 00:00:00

  • Utilising Magnetically Isolated Lysosomes for Direct Quantification of Intralysosomal Drug Concentrations by LC-MS/MS Analysis: An Investigatory Study With Imipramine.

    abstract::Lysosomes are acidic intracellular organelles that can extensively sequester basic lipophilic drugs due to pH and membrane partitioning, and therefore may significantly influence subcellular drug concentrations. Current in vitro methods for lysosomal drug sequestration evaluation typically lack the ability to accurate...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Francis L,Harrell A,Hallifax D,Galetin A

    更新日期:2020-09-01 00:00:00

  • Interaction of anionic compounds with gelatin. I: Binding studies.

    abstract::Even though gelatin is the most widely used polymeric excipient in pharmaceutical products, scant attention has been paid to its interaction with small organic molecules. The present work deals with the interaction of gelatin and four monosulfonated or monocarboxylated azo dyes having hydrocarbon moieties of different...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Gautam J,Schott H

    更新日期:1994-07-01 00:00:00

  • Colorimetric assay of benzocaine and some dosage forms.

    abstract::A colorimetric procedure for benzocaine and a number of its dosage forms was developed; it offers improvement in ease, speed, and sensitivity over the official method. The method is based on the formation of a red Schiff base between benzocaine and p-dimethylaminocinnamaldehyde in a nonaqueous acidic medium. At the ma...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Tan HS,Bruemmer GA,Shelton D

    更新日期:1977-07-01 00:00:00

  • Exploring a Kinetic Model Approach in Biopharmaceutics: Estimating the Fraction Absorbed of Orally Administered Drugs in Humans.

    abstract::Increasing costs of research and development in the pharmaceutical industry has necessitated a growing interest in the early prediction of human pharmacokinetics of drug candidates. Of growing interest is the need to understand oral absorption, the most common route of small molecule drug administration. The fraction ...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Chiang PC,Liu J,Fan P,Wong H

    更新日期:2018-07-01 00:00:00

  • Solubilization of fluasterone.

    abstract::Solubilization of nonpolar drugs constitutes one of the most important tasks in parenteral formulations design. This study investigates and assesses the solubility enhancement of Fluasterone by various techniques including cosolvency, micellization, and complexation. Of the solubilizing agents used, the modified beta-...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Zhao L,Li P,Yalkowsky SH

    更新日期:1999-10-01 00:00:00

  • Dynamics of disinfection of selected preservatives against Escherichia coli.

    abstract::Mathematical models were determined relating preservative concentration and D values (decimal reduction times at 25 degrees C; pH 6.9-7.1) against Escherichia coli in aqueous medium. Preservatives investigated were 2-bromo-2-nitro-1,3-propanediol (Bronopol), N-(hydroxymethyl)-N-(1,3-dihydroxymethyl-2, 5-dioxo-4-imidaz...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Hurwitz SJ,McCarthy TJ

    更新日期:1985-08-01 00:00:00

  • Stereoselective pharmacokinetics and inversion of suprofen enantiomers in humans.

    abstract::The stereoselective pharmacokinetics of suprofen enantiomers has been studied in humans by means of stable isotope-labeled pseudoracemate-diastereomer methodology. After a single oral dose of a near equimolar mixture of unlabeled-(R)-(-)- and [2H3]-(S)-(+)-suprofen [or unlabeled-(S)- and [2H3]-(R)-suprofen] to three h...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Shinohara Y,Magara H,Baba S

    更新日期:1991-11-01 00:00:00

  • Antiangiogenic drugs: current knowledge and new approaches to cancer therapy.

    abstract::Angiogenesis--process of new blood-vessel growth from existing vasculature--is an integral part of both normal developmental processes and numerous pathologies such as cancer, ischemic diseases and chronic inflammation. Angiogenesis plays a crucial role facilitating tumour growth and the metastatic process, and it is ...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章,评审


    authors: Mauriz JL,González-Gallego J

    更新日期:2008-10-01 00:00:00

  • Theoretical description of transdermal transport of hydrophilic permeants: application to low-frequency sonophoresis.

    abstract::Application of ultrasound enhances transdermal transport of drugs (sonophoresis). The enhancement may result from enhanced diffusion due to ultrasound-induced skin alteration and/or from forced convection. To understand the relative roles played by these two mechanisms in low-frequency sonophoresis (LFS, 20 kHz), a th...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Tang H,Mitragotri S,Blankschtein D,Langer R

    更新日期:2001-05-01 00:00:00

  • Evaluation of Transdermal Drug Permeation as Modulated by Lipoderm and Pluronic Lecithin Organogel.

    abstract::The transdermal delivery of 2 fluorescent probes with similar molecular weight but different lipophilicity, into and through the skin from 2 commercially available transdermal bases, pluronic lecithin organogel, and Lipoderm® has been evaluated. First, in vitro penetration of fluorescein sodium and fluorescein (free a...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Zhang Q,Song Y,Page SW,Garg S

    更新日期:2018-02-01 00:00:00

  • Prediction of the possibility of the second peak of drug plasma concentration time curve after iv bolus administration from the standpoint of the traditional multi-compartmental linear pharmacokinetics.

    abstract::It is shown that the existence of the second peak on the drug plasma concentration time curve C(p)(t) after iv bolus dosing can be explained by considering the traditional multi-compartmental linear pharmacokinetics. It was found that a direct solution of the general three-compartment model yields the second peak of C...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Berezhkovskiy LM

    更新日期:2008-06-01 00:00:00