This report aims to facilitate the implementation of the Three Rs (reduction, refinement and replacement) in the testing of vaccines for regulatory and other purposes. The focus is predominantly on identification of reduction and refinement opportunities in batch potency testing but the principles described are widely applicable to other situations that involve experimental infections of animal...

The objective of good laboratory practice (GLP) is to obtain accurate and precise results, using a measurement system that is functioning properly and to the specifications required by global regulatory bodies such as the United States Pharmacopeia (USP) and European Pharmacopoeia (EP). The Agilent Cary 8454 UV‐Visible spectroscopy system includes a UV‐Visible instrument based on leading LC pho...

The incidence and nature of microbial contamination of intravenous fluids prepared by four manufacturing establishments in Kenya was evaluated using the European Pharmacopoeia membrane filtration method for sterility testing. The percentage failures were 28.6% for source D, 18.8% for source A, 12.5% for source B and 10.5% for source C. The major contaminant was aspergillus which was isolated fr...

An official liquid chromatographic method for the analysis of erythromycin and related substances, which is based on a polymer reversed-phase, is described in the European Pharmacopoeia and in the United States Pharmacopeia. The pH of the mobile phase used in this system is 9.0. Recent advanced technology has led to the introduction of a new generation of silica-based reversed-phase column pack...

Two HPLC methods such as cefadroxil and cefalexin methods were compared in their performance for the quantitative analysis of the content and purity of β-lactamic antibiotic, cefradine, for six bulk drug samples. Between the two methods, the cefadroxil method prescribed by the European Pharmacopoeia (EP) for the determination of impurities in cefradoxil was superior to the cefalexin method pres...

Biomucoadhesive tablets are widely used to formulate topical antifungal drugs for treating acute oral candidiasis. The research focuses on the pharmaco-technological control of certain bio-mucoadhesive tablets containing miconazole nitrate, formulas developed and prepared by the authors based on the original formulas. The analyzed parameters were: macroscopic aspect, physical-chemical (pH) and ...

In this contribution, an overview on the current legal requirements regarding limits for heavy metals in plant material is given, drawing particular attention to the limits for lead, cadmium and mercury in herbal drugs proposed for the European Pharmacopoeia (Ph. Eur.). A new set of data resulting from about 7100 samples of herbal drugs (fresh and dried) tested for lead and cadmium and about 25...

This paper describes a fully-automated system (AUTO DISS((R))) for the determination of active ingredient release of solid oral dosage forms according to the paddle method of the US Pharmacopoeia (USP) and European Pharmacopoeia.Twenty batches can be tested continuously, with the six individuals (tablets, capsules etc.) of one batch being examined synchronous. The components of the AUTO DISS((R...

A simple analytical high-performance liquid chromatography (HPLC) method was applied for the enantiomeric excess determination of esomeprazole ((S)-OME), the enantiopure active ingredient contained in drug products, in the presence of its potential organic impurities A-E. The enantioselective separation was accomplished on the immobilized-type Chiralpak ID-3 chiral stationary phase (CSP) under ...