Background Sepsis is a major contributor to neonatal mortality, particularly in low-income and middle-income countries (LMICs). WHO advocates ampicillin-gentamicin as first-line therapy for the management of neonatal sepsis. In the BARNARDS observational cohort study of neonatal sepsis and antimicrobial resistance in LMICs, common sepsis pathogens were characterised via whole genome sequencing (WGS) and antimicrobial resistance profiles. In this substudy of BARNARDS, we aimed to assess the use and efficacy of empirical antibiotic therapies commonly used in LMICs for neonatal sepsis.Methods In BARNARDS, consenting mother-neonates aged 0-60 days dyads were enrolled on delivery or neonatal presentation with suspected sepsis at 12 BARNARDS clinical sites in

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The systematic approach developed to assess the amount of residues left on manufacturing equipment surfaces from product carryover is known as cleaning validation. Current trends have seen increasing demand for rapid sample analysis time along with low detection limits for verification of cleaning validation samples. A total organic carbon (TOC) method is sensitive to the ppb range and is less time consuming than high performance liquid chromatography (HPLC). The purpose of this study is to demonstrate how to develop and validate a TOC method for cleaning applications. Validation of the cleaning procedures for manufacturing or processing equipment has been presented in this paper. A sensitive and reproducible method was developed and validated for the determination of cephradine in swab samples. The method for determining residues of cephradine on manufacturing equipment surfaces was validated for precision, linearity, accuracy, limit of quantification and % recovery of a potential contaminant. The sampling procedure using cotton swabs was also validated. A mean recovery from stainless steel plate close to 78% was obtained. The assay was linear over the concentration range of 30 to 600 ng ml À1 concentration (R z 0.9987). The calculated limit of contamination value was less than 315 mg cm À2 , during three consecutive cleaning trials.

This review is compilation of studies performed on stability and degradation of Ascorbic acid (AA) creams by keeping goal in mind to finely demonstrate the central premise of this article that is to cover all aspects related to degradation in pharmaceutical creams. It was required to deep insight into degradation specifically in pharmaceutical creams, influences for phenomenon, degradation products, stability concerns and its effects on efficacy and safety of pharmaceutical creams. Method: A literature survey was carried out using scientific websites for publications according to predetermined search sequence. Ascorbic acid cream was taken as model in few articles to illustrate relevant studies. Result: Light, temperature, pH, microbial contamination, incompatibility of active ingredient or excipients, closure and packing material are the influential factors that may led pharmaceutical creams towards instabilities or degradation. Conclusion: This article concludes with the overview of published articles that there are certain factors of degradation in creams and by routine stability testing and adopting appropriate precautionary measures degradation in creams can be controlled and minimize.

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