A fully validated microbiological assay for daptomycin injection and comparison to HPLC method

Christ, Ana Paula Guarnieri; Machado, Mariana Souto; Ribas, Karla Giacomelli; Schwarzbold, Alexandre Vargas; Silva, Cristiane de Bona da; Adams, Andréa Inês Horn

doi:10.1590/s1984-82502015000400003

Cited by 7 publications

(5 citation statements)

References 23 publications

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“…The residual CEZ was measured using the HPLC method and microbiological assay in this study, which are both standard methods for measuring the residual level of antibiotics [ 15 , 16 ]. Although these methods each have advantages, there is no significant difference between them [ 2 ]. As such, the test results were not considered to differ between methods.…”

Section: Discussionmentioning

confidence: 99%

Effects of temporary cessation of milking following intramammary cefazolin sodium infusion on residual antibiotic in lactating dairy cows

Sato

Ohashi

Tsukano

et al. 2021

The Journal of Veterinary Medical Science

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The aims of studies were to estimate the withdrawal period of antibiotic from milk after the intramammary infusion of cefazolin sodium (CEZ) in cows with difficulties in frequent milk discharge due to disease such as teat injury. The period was compared among cows milked twice a day after 150 or 450 mg of CEZ were administered to all quarters (Study 1, 2) and the cows in which milking of front-right quarter was ceased for five days after administration of these infusions to only that quarter (Study 3). In Studies 1 and 2, the median of 17.66 µg/ml and 83.18 µg/ml of CEZ were detected in the samples of first milking after intramammary administration, respectively; however, there was no residual antibiotic by 72 hr in all cows. In Study 3, the median of 1.96 µg/ml of CEZ was detected in the sample after the resumption of milking at 120 hr, and the residual was eliminated by 174 hr. The withdrawal period may be prolonged by the cessation of milking after administration, and the period is the total time from cessation to 72 hr after the resumption of milking.

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Section: Discussionmentioning

confidence: 99%

Effects of temporary cessation of milking following intramammary cefazolin sodium infusion on residual antibiotic in lactating dairy cows

Sato

Ohashi

Tsukano

et al. 2021

The Journal of Veterinary Medical Science

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“…The principle of this method is the drug diffusion on an agar surface inoculated with a microorganism, producing a inhibition zone of growth that is measured (20)(21)(22) and allows to determine the drug potency and to detect small variances in biological activity. Agar diffusion methods have been the methodology chosen for water-soluble antibiotics (23). For the present study, the culture medium was selected based on similar methodologies described for others similar carbapenems: meropenem and doripenem (13,18).…”

Section: Methodology Optimizationmentioning

confidence: 99%

Microbiological Assay for Quantitative Determination of Imipenem in Powder for Injection

et al. 2018

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This work describes the development and validation of a microbiological method using the cylinder-plate assay for quantitative determination of imipenem in powder for injection. The aim was to obtain a low-cost and suitable methodology that can be alternative to physicochemical techniques already described, contributing for the quality control of this antibiotic. Firstly, the analytical conditions were optimized, testing the microorganism, inoculum concentration and best range of sample and standard concentrations, in a way that provides the adequate measurement of the inhibition halos. Staphylococcus epidermidis ATCC 12228 was selected as test microorganism, as well as 2.0 % of inoculum concentration. The validation protocol followed the official guidelines, and the parameters evaluated were linearity, precision (intermediate precision and repeatability) and accuracy. All standard curves ranging 0.5-2.0 µg/mL showed r values higher than 0.999, and ANOVA confirmed that were no deviation from linearity (p-value > 0.05). The method also proved to be precise with RSD (relative standard deviation) values ranging 0.28-0.64 for repeatability and 2.49 for intermediate precision. It was performed three days of experiments, being three assays of eight plates a day. The drug mean content was 101.05%. Accuracy was assessed by recovery test, with standard recovery percentage of 101.70-107.90% (mean recovery = 104.86%), which was considered satisfactory. Therefore, the proposed microbiological method was considered validated and suitable for application in quantitative determination of this drug, being useful for quality control routine.

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“…The factors considered were incubation time, temperature and pH (antibiotic medium no. 1) [17,26]. Minor and limited deviations or drifts from the standard official assay conditions should not adversely impact the resultant computed potency and it should not show significant shift from expected estimate from that calculated under ideal experimental and laboratory conditions [27].…”

Section: Robustness Of the Microbiological Designmentioning

confidence: 99%

Microbiological Antibiotic Assay Validation of Gentamicin Sulfate Using Two-Dose Parallel Line Model (PLM)

Eissa

Rashed²,

Eissa³

2021

HighTech. Innov. J.

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Till nowadays microbiological assay is still widely used with several antibiotics that are composed of a mixture of related active compounds. However, obtaining a reasonably valid determination of the potency is dependent on the validity and the suitability of the assay design. The present work aimed to validate an assay design of an aminoglycoside antibiotic (Gentamicin Sulfate) using a two-dose Parallel Line Model agar diffusion assay in a large 8×8 rectangular plate. All preparatory procedures were done following United States Pharmacopeia and the Inhibition Zones were measured using a digital caliper to the nearest 0.01 mm. Analysis of variance of compendial requirements of regression and parallelism were found to be satisfactorily meeting the acceptance criteria. Specificity was achieved for the product under investigation with no detectable IZ that could be found for all components except the antibiotic. The validation method showed acceptable linearity of r2≥0.98. Accuracy and precision parameters showed RSD (%)<2. All relative error value estimates were below 4%. The proposed validation design for 32×32 cm antibiotic plates yielded valid results and can be projected for the routine Quality Control analysis of the antibiotic material, especially which is incorporated into a finished medicinal dosage form. Doi: 10.28991/HIJ-2021-02-04-04 Full Text: PDF

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A fully validated microbiological assay for daptomycin injection and comparison to HPLC method

Cited by 7 publications

References 23 publications

Effects of temporary cessation of milking following intramammary cefazolin sodium infusion on residual antibiotic in lactating dairy cows

Effects of temporary cessation of milking following intramammary cefazolin sodium infusion on residual antibiotic in lactating dairy cows

Microbiological Assay for Quantitative Determination of Imipenem in Powder for Injection

Microbiological Antibiotic Assay Validation of Gentamicin Sulfate Using Two-Dose Parallel Line Model (PLM)

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