Application Notes: Pharmaceuticals

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For many years, the use of guard columns has been advocated by column manufacturers and other experts to protect and extend column lifetime and performance of analytical columns from potential damage caused by the presence of chemical contaminants and microparticulates in the sample and mobile phase.

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Synthetic and natural materials are used in motor vehicles to provide appealing and safe vehicle interiors. The manufacturing process for these materials include volatile (VOC) and semi volatile organic compounds (SVOC), which are released into the interior of vehicles. These compounds produce that new smell, but also create fog on interior glass surfaces of the car and can cause health issues.

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Ingestion of DEG-adulterated glycerin excipients in pharmaceuticals and personal care products, such as toothpaste, mouth wash, and medicinal syrups has caused systemic alcohol intoxication, acidosis, and subsequent multi-organ failure that have led to hundreds of fatalities of children and adults (1). To help prevent future adulterations, the U.S. FDA requested that the U.S. Pharmacopeia (USP) revise the USP 32 NF 26 monograph to identify and quantify EG and DEG in sorbitol solutions at the maximum limit of 0.1%. The revised monograph (USP 33-NF 28) meets these criteria using GC-FID (2).

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Heating is a common and essential requirement in most biopharmaceutical production methods. Chitosan is an amino polysaccharide obtained by alkaline deacetylation of naturally abundant chitin. It is known as a potentially beneficial material in many pharmaceutical applications such as tissue engineering, drug delivery, cell encapsulation, and medical devices.

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Lactose, a major disaccharide found in milk products, is catabolized into glucose and galactose by the enzyme lactase. Lactose-intolerant individuals have a lactase deficiency; therefore lactose is not completely catabolized.