Pharmaceutical products procedures

Dissociation extraction is the process of using chemical reac tion to force a solute to transfer from one liquid phase to another. One example is the use of a sodium hydroxide solution to extract phenolics, acids, or mercaptans from a hydrocarbon stream. The opposite transfer can be forced by adding an acid to a sodium phenate stream to spring the phenolic back to a free phenol that can be extrac ted into an organic solvent. Similarly, primary, secondary, and tertiary amines can be protonated with a strong acid to transfer the amine into a water solution, for example, as an amine hydrochloride salt. Conversely, a strong base can be added to convert the amine salt back to free base, which can be extracted into a solvent. This procedure is quite common in pharmaceutical production. 

This procedure was tested in the analysis of pharmaceutical products Poltava s bishofite (series Elite and Profi ) and a brine of bischofite with rusty precipitate. The data bear out the sufficient accuracy and reproducibility of the proposed procedure which allows to perform the determination magnesium, iron, copper and zinc ions at concentrations above 10 M. It was found that the content of Mg ion in the studied brine decreases in comparison with Poltava s bishofite . The Fe, Cu and Zn ions were not detected in the brine. 

For pharmaceutical products, the synthesis route is usually established very early on because of drug registration procedures carried out with governmental agencies, e.g. the Food and Drug Administration (FDA). 

There are three procedures by which pharmaceutical products may gain a marketing authorization in the EEA. These are the National, Mutual Recognition, and Centralized procedures. 

With the organism grown in this manner the sensitivity of the assay is improved. Greely et al2 2 have applied the automated respirometric method to the determination of neomycin in pharmaceutical products and compared these assays with the results obtained by the cylinder-plate procedure on the same samples. Good correlation between the two procedures was demonstrated. 

Pharmaceutical products and services Outpatient medical care Laboratory tests Diagnostic tests and procedures Direct Nonmedical... 

Protein pharmaceutical products, genetic engineering procedures for,... 

Several in vitro tests are currently employed to assure drug product quality. These include purity, potency, assay, content uniformity, and dissolution specifications. For a pharmaceutical product to be consistently effective, it must meet all of its quality test criteria. When used as a QC test, the in vitro dissolution test provides information for marketing authorization. The dissolution test forms the basis for setting specifications (test, methodology, acceptance criteria) to allow batch release into the market place. Dissolution tests also provides a useful check on a number of physical characteristics, including particle size distribution, crystal form, etc., which may be influenced by the manufacturing procedure. In vitro dissolution tests and QC specifications should be based on the in vitro performance of the test batches used in in vivo studies or on suitable compendial specifications. For conventional-release products, a single-point dissolution... 

This chapter reviews the myriad SP techniques used in pharmaceutical analysis and focuses discussion on those commonly used for pharmaceutical products, such as grinding, mixing, sonication, dilution and filtration. The best practices and technical judgments used in developing SP procedures are illustrated with several case studies of assays and impurity testing. 

During the last few years, a number of specific monographs for different pharmaceutical products have appeared in pharmacopoeias in which CE is prescribed as one of the analytical procedures. Several comparative studies have been reported in which established analytical procedures described in pharmacopoeial monographs were compared with capillary electrophoretic methods or in which CE was evaluated as a valuable additional technique.Based on the results, some analytical procedures have been replaced by CE-based alternative methods in a number of monographs. For other products, CE has been included in the monograph from the initial version onwards. In addition, CE has been applied... 

R.M. Issa, K.M. El-Marsafy and M.M. Gohar, Application of the near infrared spectrophotometry as an analytical procedure for the determination of water in organic compounds and pharmaceutical products, An. Quim., 84, 312-315 (1988). 

SOPs are documents which detail how staff should undertake particular procedures or processes. These procedures/processes are usually of a general nature, often being independent of any one pharmaceutical product. Many SOPs fall into one of several general categories, including ... 

This approach to defining cost therefore proposes a three-step procedure for the evaluation of new pharmaceutical products. Assume that there is some threshold value V for cost per QALY that appropriately governs resource allocation. 

Pharmaceutical analysis procedures may be used to answer any of the questions outlined in Box 1.1 above. The quality of a product may deviate from the standard required but in carrying out an analysis one also has to be certain that the quality of the analysis itself is of the standard required. Quality control is integral to all... 

Vacancy chromatography has a number of applications areas in practice, none of which appear to have been extensively exploited. One particularly interesting application is that of quality control. If a particular product has a number of components present, and their relative composition must be kept constant as in, for example, a pharmaceutical product, Vacancy Chromatography can provide a particularly simple analytical procedure for quality control. The mobile phase is made up containing the components of the product in the specified proportions, but at a low concentration suitable for LC analysis. A sample of the product is dissolved in some pure mobile phase at the same total mass concentration as the standards in the mobile phase. A sample is then injected on the column. If the product contains the components in the specified proportion, no peaks will appear on the chromatogram as the sample and mobile phase will have the same composition. If any component is in excess, it will show a positive peak. If any component is present below specifications, it will show a negative peak. The size of the peak will provide an accurate measure of the difference between the sample and that of the required standard. 

To gain FDA approval or license for marketing, a pharmaceutical product must be shown to be safe and effective for its proposed or intended use. The drug company or sponsor must also provide evidence to show that the processes and control procedures used for synthesis, manufacture, and packaging are independently validated to ensure that the pharmaceutical product meets established standards of quality. The overall effort from the inception of a new molecular entity and the establishment of analytical, scale-up, and quality control procedures, to the collection of safety and efficacy data for consideration by the FDA as part of an NDA or BLA, is called the drug development process. 

In a first approach, the definition of contamination in pharmaceutical products can be referred to in terms of related substances and process contaminants While related substances are structurally related to the drug substance, process contaminants are introduced during manufacturing or handling procedures. These two categories include all types of contaminants but do not define them. 

Schoenmakers et al. [72] analyzed two representative commercial rubbers by gas chromatography-mass spectrometry (GC-MS) and detected more than 100 different compounds. The rubbers, mixtures of isobutylene and isoprene, were analyzed after being cryogenically grinded and submitted to two different extraction procedures a Sohxlet extraction with a series of solvents and a static-headspace extraction, which entailed placing the sample in a 20-mL sealed vial in an oven at 110°C for 5,20, or 50 min. Although these are not the conditions to which pharmaceutical products are submitted, the results may give an idea of which compounds could be expected from these materials. Residual monomers, isobutylene in the dimeric or tetrameric form, and compounds derived from the scission of the polymeric chain were found in the extracts. Table 32 presents an overview of the nature of the compounds identified in the headspace and Soxhlet extracts of the polymers. While the liquid-phase extraction was able to extract less volatile compounds, the headspace technique was able to show the presence of compounds with low molecular mass... 

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