PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Drug Contamination”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 145 records · Page 8Linked to original sources
PubMed1988

Inactivation of the Hutchinson strain of hepatitis non-A, non-B virus in intravenous immunoglobulin by beta-propiolactone.

beta-propiolactone (beta-PL) treatment has been evaluated for its ability to inactivate 10(3.5) chimpanzee infectious doses (CID50) of the Hutchinson strain of hepatitis non-A, non-B virus (HNANBV). Two chimpanzees were inoculated with a beta-PL-treated immunoglobulin solution to which this dose of the titrated virus had been added prior to beta-PL treatment. beta-PL treatment was performed in accordance with the production procedure used for a licensed intravenous immunoglobulin preparation. Neither animal developed hepatitis. When subsequently challenged with the same spiked immunoglobulin solution that had not been beta-PL treated, both animals developed clear-cut hepatitis non-A, non-B. The results of this experiment demonstrate that beta-PL treatment is effective for the inactivation of hepatitis non-A, non-B virus in intravenous immunoglobulin.

Animals↗
PubMed2005

High speed development work by preparation of an "in-hand" library of NMR-quantified degradation products.

Standard materials of impurities are needed in pharmaceutical development such as for validating impurity analytical methods. Most often the impurities possess structures, which are difficult and very time consuming to synthesize. In the present work, we demonstrate that a library of degradation products of ragaglitazar--a novel tricyclic-gamma-alkyloxyphenylpropionic acid with hypolipidemic and antidiabetic activity--observed in stability indicating samples of a solid dosage formulation by LC-MS can be produced in a one pot oxidation reaction. The library entities were isolated in small quantities (microg-mg) by preparative HPLC and structurally characterized by NMR spectroscopy and mass spectrometry. The concentrations of the library entities were determined in solution by NMR using an internal standard method. The library was successfully used in the validation work of a newly developed purity method for the drug product providing useful response factors and relative retention times (RRTs) of the degradation products.

Chromatography, High Pressure Liquid↗
PubMed2007

Evaluation of hydroperoxides in common pharmaceutical excipients.

While the physical properties of pharmaceutical excipients have been well characterized, impurities that may influence the chemical stability of formulated drug product have not been well studied. In this work, the hydroperoxide (HPO) impurity levels of common pharmaceutical excipients are measured and presented for both soluble and insoluble excipients. Povidone, polysorbate 80 (PS80), polyethylene glycol (PEG) 400, and hydroxypropyl cellulose (HPC) were found to contain substantial concentrations of HPOs with significant lot-to-lot and manufacturer-to-manufacturer variation. Much lower HPO levels were found in the common fillers, like microcrystalline cellulose and lactose, and in high molecular weight PEG, medium chain glyceride (MCG), and poloxamer. The findings are discussed within the context of HPO-mediated oxidation and formulating drug substance sensitive to oxidation. Of the four excipients with substantial HPO levels, povidone, PEG 400, and HPC contain a mixture of hydrogen peroxide and organic HPOs while PS80 contains predominantly organic HPOs. The implications of these findings are discussed with respect to the known manufacturing processes and chemistry of HPO reactivity and degradation kinetics. Defining critical HPO limits for excipients should be driven by the chemistry of a specific drug substance or product and can only be defined within this context.

Cellulose↗
PubMed1980

Preparation, characterization, and stability of new prostaglandin E2 gel for local administration.

A new gel delivery system for the local application of prostaglandin E2 consists of drug incorporated in the matrix of a cross-linked starch polymer. The properties of the starch powder provide a stabilizing milieu for the labile prostaglandin E2 and, by addition of saline, a ready-to-use gel for immediate local administration. The gel offers advantages over existing preparations in terms of chemical and microbiological stability, homogeneity, and dosage safety. This report outlines the pharmaceutical aspects involved in the development of the delivery system.

Administration, Topical↗
PubMed1982

GLC method for iminodibenzyl and desipramine impurities in imipramine hydrochloride and its formulated products.

A GLC method is described for the determination of iminodibenzyl and desipramine impurities in imipramine hydrochloride and its formulated products. These impurities were extracted from an alkaline solution with a mixture of 30% methylene chloride in hexane for chromatography on a 3% OV-17 GLC column. Iminodibenzyl was determined using anthracene as an internal standard and desipramine was determined (after derivatization) using nortriptyline as an internal standard. Based on spiked excipient mixtures typically used to compound imipramine tablets, recoveries were 93-109% for iminodibenzyl and 93-107% for desipramine at 0.2-0.4% of the labeled claim of imipramine. Minimum detection levels were approximately 0.02% for each impurity, and procedural standards gave coefficients of variation of less than 1% for each impurity. The method was linear in the 0.05-0.5 microgram range and typically gave correlation coefficients greater than or equal to 0.999.

Amines↗
PubMed1983

Determination of hydrazine in pharmaceuticals III: hydralazine and isoniazid using GLC.

A GLC procedure has been developed for the determination of hydrazine in hydralazine and isoniazid drug raw materials, single and multicomponent tablets, injectables, and syrups. The method is based on the derivatization of hydrazine with benzaldehyde to form benzalazine. The minimum detectable amount of hydrazine in hydralazine and isoniazid raw materials and formulations is approximately 0.0003%. No hydrazine was found in the hydralazine raw material specimens examined. Traces of hydrazine (approximately 0.0003%) were found in some tablet lots and approximately 0.02% was found in an injectable product. A trace of hydrazine was found in one lot of isoniazid raw material and low levels (0.0012 and 0.0029%) were found in isoniazid tablet products. An isoniazid syrup contained approximately 0.2% hydrazine.

Chemistry, Pharmaceutical↗
PubMed1983

Hydrazine levels in formulations of hydralazine, isoniazid, and phenelzine over a 2-year period.

Hydrazine levels in formulations of hydralazine, isoniazid, and phenelzine have been measured over a 2-year period under ambient conditions and under temperature and humidity stress. Hydralazine tablets are stable under ambient conditions, but the hydrazine level in an injectable formulation increased from 4.5 to 10 micrograms/ml over a 23-month period. Isoniazid tablets are also stable, but hydrazine levels in an elixir and a pyridoxine combination product doubled to 44 micrograms/ml and 19 micrograms/tablet, respectively. Levels in phenelzine tablets appeared to remain constant at approximately 60 micrograms/tablet, with considerable tablet-to-tablet variation.

Drug Contamination↗
PubMed1984

Determination of the structure of a synthetic impurity in guaifenesin: modification of a high-performance liquid chromatographic method for phenylephrine hydrochloride, phenylpropanolamine hydrochloride, guaifenesin, and sodium benzoate in dosage forms.

An impurity present in all commercial guaifenesin-containing dosage forms examined was isolated and identified as 2-(2-methoxyphenoxy) 1,3-propanediol (VI). The eluant of a previously developed stability-indicating liquid chromatographic method for phenylephrine hydrochloride (I), phenylpropanolamine hydrochloride (II), and guaifenesin (III) was modified to yield a better separation between phenylpropanolamine and the impurity. The method was expanded to include sodium benzoate (IV), a preservative found in some liquid formulations.

Benzoates↗
PubMed1993

Survival of Staphylococcus aureus in oral administration liquid medicaments and influence of count medium on survival.

The survival of Staphylococcus aureus was studied in 30 oral administration liquid medicaments (15 syrups and 15 solutions) to determine the effectiveness of the preservatives, the influence of the culture medium used in the enumeration of the surviving microorganisms, and the loss of the enzyme coagulase, phosphatase, DNase (deoxyribonuclease), and thermonuclease. Samples were inoculated with 6.3-6.5 x 10(5) viable cells per milliliter and were stored at room temperature for 60 days. Aliquots were taken for analysis at 0, 15, 22, 30, and 60 days after samples were inoculated. The enumeration of S. aureus was made by most probable number method (MPN) with six liquid culture media: triptone soy (TS), TS with 10% NaCl (TSS), TS and TSS with 0.2% catalase, Mannitol salt, and Tellurite-mannitol-glycine. The survival of S. aureus was lower in solutions than in syrups, decreased with the storage time, and depended on the culture medium utilized in the enumeration. Nonselective media were more sensitive than selective ones; that is, a better percentage of recovery was achieved with TS and the catalase medium. The preservative was effective in 93.3% of the samples. Coagulase was the most stable enzyme and phosphatase, DNase, and thermonuclease disappeared during the storage period.

Administration, Oral↗