Validation of the SL3 beta-Lactam Test for screening milk in compliance with U.S. pasteurized milk ordinance: performance tested method 040701.

The SL3 beta-Lactam Test is a 3 min, receptor-based lateral flow Rapid One Step Assay (ROSA) that detects 5 of 6 beta-lactam drugs approved for dairy cattle in the United States. The method was evaluated through the AOAC Research Institute Performance-Tested Method program following a U.S. Food and Drug Administration protocol. Three combined lots detected penicillin G 4.2 parts per billion (ppb), ampicillin 8.7 ppb, amoxicillin 7.8 ppb, cephapirin 16.0 ppb, and ceftiofur (total metabolites) 51 ppb at least 90% of the time, with 95% confidence as determined by dose response probit analysis. These detection levels are less than safe level/tolerances but not more than 50% less. Lot repeatability was within 20%. Incurred residues were detected comparably or more sensitively to fortified samples due to the cumulative effect of biologically active metabolites. There were no interferences from somatic cells at 1 M/mL, bacterial cells 500 000 colony-forming units/mL, or 30 other non-beta-lactam drugs. These performances met approval conditions of the National Conference on Interstate Milk Shipments. Ruggedness conditions were incorporated into public health procedures for annual laboratory proficiency and certification.

Synthesis and in vitro-anticancer and antimicrobial evaluation of some novel quinoxalines derived from 3-phenylquinoxaline-2(1H)-thione.

Two novel series derived from 3-phenylquinoxaline-2(1H)-thione 2 and 2-(hydrazinocarbonylmethylthio)-3-phenylquinoxaline 6 have been synthesized. Eight out of twenty six new compounds were selected at the National Cancer Institute for evaluation of their in vitro-anticancer activity. Among them, compounds 3b, 3c, 4b, and 4c displayed moderate to strong growth inhibition activity against most of the tested sub-panel tumor cell lines with GI(50) 10(-5) to 10(-6 )molar concentrations. Compound 4b exhibited a significant value of percent tumor growth inhibition against breast cancer at concentration < 10(-8) M. Compound 4c showed moderate selectivity towards leukemia cell lines with GI(50) of 1.8 to 3.8 microM (selectivity ratio = 5.7). Preliminary antimicrobial testing revealed that compounds 7a, 7b, 8a, 11a, and 11b were as active as ampicillin against B. subtilis (MIC = 12.5 microg/mL). Compounds 7b and 8a were also nearly as active as ampicillin against E. coli (MIC = 12.5 microg/mL). In addition, compounds 4a, 7b, 10b, and 11a were as active as ampicillin against P. aerugenosa (MIC = 50 microg/mL). However, compounds 7b, 8a, and 10b showed mild activity against C. albicans (MIC = 50 microg/mL). The values of minimum bactericidal concentrations indicated that compounds 4a and 7b were bactericidal against B. subtilis and P. aerugenosa, respectively, while compound 10b was bactericidal against both organisms. However, compound 11a was bactericidal against E. coli, P. aerugenosa, and S. aureus.

The quality of drugs in private pharmacies in Lao PDR: a repeat study in 1997 and 1999.

OBJECTIVE: To present a repeated test of the quality of ampicillin, tetracycline, chloroquine and ASA from private pharmacies in Laos in 1997 and 1999, and to discuss the quality in relation to the National Drug Policy Programme. METHOD: A total of 115 of 214 licensed private pharmacies were selected in Savannakhet province, a pilot province in the Lao National Drug Policy Programme. The four drugs, if available, were collected at each pharmacy. Thirty tablets of each drug were taken from a selected container. In 1997, 366 samples were analysed and three hundred in 1999. Identity, assay (content of active component) and measurement of weight variation tests were performed. Drug quality was compared mainly according to the standards of the British and United States' pharmacopoeias. RESULTS: The percentage of substandard drugs decreased significantly from 46% to 22% between 1997 and 1999 (P< 0.001). Substandard ampicillin and tetracycline were reduced significantly from 67% to 9% and from 38% to 12%, respectively (P < 0.001). In total, 3% vs 1% contained no active ingredient, 12% vs 4% had too little or too much active ingredient, and 35% vs 14% had weight variation outside pharmacopoeial limits. CONCLUSION: Drug quality was improved. However, the prevalence of substandard drugs was still unacceptably high, which may result in adverse clinical effect or treatment failure for individual patients.

Screening chemical composition and in vitro antioxidant and antimicrobial activities of the essential oils from Origanum syriacum L. growing in Turkey.

In the present study, essential oil from the leaves of Syrian oreganum [Origanum syriacum L. (Lauraceae)] grown in Turkish state forests of the Dortyol district, Turkey, was obtained by steam distillation. The chemical composition of oil was analysed by GC and GC-MS, and was found to contain 49.02% monoterpenes, 36.60% oxygenated monoterpenes and 12.59% sesquiterpenes. The major components are as follows: gamma-terpinene, carvacrol, p-cymene and beta-caryophyllene. Subsequently, the reducing power, antioxidant and 2,2-diphenyl-1-picrylhydrazyl (DPPH) radical-scavenging activities of the essential oil were studied. The reducing power was compared with ascorbic acid, and the other activities were compared with 2,6-di-tert-butyl-4-methyl phenol (BHT, butylated hydroxytoluene). The results showed that the activities were concentration dependent. The antioxidant activities of the oil were slightly lower than those of ascorbic acid or BHT, so the oil can be considered an effective natural antioxidant. Antimicrobial activities of the essential oil from the leaves of Origanum syriacum was also determined on 16 microorganisms tested using the agar-disc diffusion method, and showed antimicrobial activity against 13 of these.

Quality and bioavailability of ampicillin capsules dispensed in a Nigerian semi-urban community.

Five samples of ampicillin capsules with a label claim of 250 mg were purchased from different dispensing points in a small town in Nigeria. The pharmaceutical quality of the products and a sample from a batch produced by a local manufacturer was evaluated and five of the capsule samples were employed in an in vivo bioavailability study. Three of the five capsule samples from dispensing points were found to be of lower quality than the officially prescribed standards of pharmaceutical quality. The quality lapses observed were sufficient to bring about determinable differences in biological availability. The results demonstrate that ampicillin capsules of sub-standard chemical quality are being dispensed within the study sources from authorised and unauthorised sources and that this may have biological, clinical and epidemiological consequences.

Near-infrared spectroscopy as an alternative to assess compliance of ampicillin trihydrate with compendial specifications.

The suitability of near-infrared spectroscopy (NIRs) as an alternative to several compendial test methods such as identification, water content and assay, in the release procedure of drug substances is demonstrated with ampicillin trihydrate as an example. It is also shown that in cases in which a manufacturing process is well under control, a 'standard activity' can be assigned to a batch when its conformity with 'standard quality' is proven by means of its NIR spectrum. For that purpose a new quality parameter--the Conformity Index (CI)--is introduced.

Comparative in-vitro antibacterial activity of two brands of antibiotics against clinical isolates of some bacterial genera.

Six brands of ampicillin and four of gentamicin were compared for their in-vitro antibacterial activity against clinical isolates of Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa. The minimum inhibitory concentrations obtained for each brand against each bacterial isolate compared very well with one another, and the kinetics of bactericidal activity showed that the brands of each antibiotic possessed similar activity against the clinical isolates tested.

[Allergenic impurities in medicinal preparations containing aminopenicillin. I. Ampicillin sodium]. / Impurezze allergogene in specialità medicinali contenenti amino-penicilline. I. Ampicillina sodica.

High-performance liquid chromatography (HPLC) with gradient elution has been used for the determination of degradation products in pharmaceutical preparations containing sodium ampicillin. In all preparations resulting by lyophilization process, the degradation products amount, almost exclusively constituted of allergenic polymeric substances deriving from condensation reactions, is more than 10%. On the contrary, the sodium ampicillin prepared by precipitation in non aqueous solvents, only contains the 2% of polymeric impurities.

Stability of ampicillin, piperacillin, cefotaxime, netilmicin and amikacin in an L-amino acid solution prepared for total parenteral nutrition of newborn infants.

The stability of ampicillin, piperacillin and cefotaxime, alone or in combination with either netilmicin or amikacin, was tested by microbiological methods at 29 degrees C (ampicillin, also at 22 degrees C) in an L-amino acid solution specially prepared for newborn infants. In the case of ampicillin, the mean concentration had dropped to 84% of the initial value after 24 hours. This fall is acceptable. Piperacillin and cefotaxime were stable. Admixture of netilmicin or amikacin did not affect the activity of ampicillin, piperacillin and cefotaxime. The concentrations of netilmicin and amikacin were stable for 24 hours. Combination with ampicillin, piperacillin or cefotaxime did not affect the activity of either aminoglycoside. The antibiotics investigated could therefore be used in our TPN infusion system.

Prospective study of ampicillin rash. Report of a collaborative study group.

A multicentre prospective study of 933 patients being treated with ampicillin showed a rash incidence of 7.3%. The rash was commonest in women and patients suffering from viral infections. Most rashes were maculopapular and were not associated with features of true penicillin allergy. We conclude that the development of a maculopapular rash during or after treatment with ampicillin is not in itself a contraindication to future treatment with the penicillins.