Evaluating physical activities in clinical diabetes: lifestyle scores hypothesis.

Background: The concept of lifestyle-based risk scores is known but not evaluated in most rural communities of low- to mid-income countries. This study investigated the correlation of lifestyle scores with health indices.

Methods: This was a descriptive cross-sectional investigation.

Evaluation of the General Solution Compatibility of Polymer Materials Used in Medical Devices such as Syringes.

Unlabelled: The general compatibility between various polymers (plastic and elastomeric materials) commonly used in medical devices (e.g., syringes) and common solution-based pharmaceutical products was examined.

Utilization of internal standard response factors to estimate the concentration of organic compounds leached from pharmaceutical packaging systems and application of such estimated concentrations to safety assessment.

Substances from packaging systems that are leached into packaged medical products may have a safety impact on patients to whom such medical products are administered. The potential safety impact depends on the identity and concentration of the leached substances. The concentration above which a leachable must be identified in order to assess its safety impact is frequently estimated using an internal standard to "calibrate" the analytical response of a chromatographic system.

The effect of solvent polarity on the accumulation of leachables from pharmaceutical product containers.

Material/water equilibrium interaction constants (E(b)) were determined for 12 organic model solutes and a plastic material used in pharmaceutical product containers (non-PVC polyolefin). An excellent correlation was obtained between the measured interaction constants and the organic solute's octanol/water partition coefficient. The effect of solvent polarity on E(b) was assessed by examining the interaction between the plastic and selected model solutes in binary ethanol/water mixtures.

Accumulation of extractables in buffer solutions from a polyolefin plastic container.

Plastic materials are widely used in medical items, such as solution containers, transfusion sets, transfer tubing and devices. An emerging trend in the biotechnology industry is the utilization of large plastic containers to prepare, transport and store an assortment of solutions including buffers, media and in-process and finished products. The direct contact of such containers with the product at one or more points in its lifetime raises the possibility that container extractables may end up in the finished product.

Development and validation of chromatographic methods for the identification and quantitation of organic compounds leached from a laminated polyolefin material.

Chromatographic methods for the identification of organic compounds leached from a plastic material used in solution containers in the pharmaceutical industry are described. Based on a set of compounds identified in extracts of a multilayered polyolefin film, targeted leachables are delineated for accumulation assessments, and methods to perform target quantitation are developed and validated.

Determination of 1,4-dioxane impurity levels in Triton X-100 raw material by gas chromatography with mass spectrometric detection.

Triton X-100 (octoxynol 9) is a commercially available surfactant used as a solvent detergent in numerous pharmaceutical applications including virus inactivation. A byproduct formed during its synthesis is 1,4-dioxane, the cyclic dimer of ethylene oxide and a possible carcinogen to humans. The United States Pharmacopoeia (USP) contains a labor-intensive 1,4-dioxane test for Triton X-100.