Application Notes: Pharmaceutical - Chromatography Online
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Application Notes: Pharmaceutical

Determination of Diethylene Glycol in Sorbitol Solutions Used for Pharmaceutical Formulations

July 2, 2010

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 multiorgan failure that have led to hundreds of fatalities of children and adults.

Effect of Heating on Molecular Weights of Chitosan

June 1, 2010

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.

Determination of Diethylene Glycol in Sorbitol Solutions Used for Pharmaceutical Formulations

June 1, 2010

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).

Development of a High-Throughput LC–MS-MS Assay for 13 Commonly Prescribed Pain Management Drugs from Urine with Cleanup Using Solid Phase Extraction (SPE)

June 1, 2010

In pain management analysis, urine is often used as it is a copiously available bodily fluid that can be collected easily and used for analysis. Urine, however, can cause difficulties in analysis due to the variances in the endogenous nature of the urine matrix, which can impact the chromatographic separation and quantitation.

EDTA by Anion Exchange HPLC

June 1, 2010

Hamilton Company is best known for manufacturing precision fluid measuring products, including syringes for HPLC and GC. For the last 30 years Hamilton Company has manufactured HPLC resins and columns while developing separations for customers. Two of the separations are highlighted below.

Evaluation of the Gas-Liquid Separator in the Mass-Directed SFC Prep System with Open-Bed Collection

June 1, 2010

With many "blockbuster" drugs losing patent protection, there has been mounting pressure across the pharmaceutical industry to shorten the time to bring new chemical entities (NCEs) to market and reduce the overall cost. This requires concerted productivity improvement in many aspects of drug discovery and development by continuously adopting new enabling technologies.

Fast Analysis of Naproxen Sodium with the Acclaim Trinity P1 Column and Charged Aerosol Detection

June 1, 2010

The characterization of pharmaceutical salts is critical to the drug development process. Active Pharmaceutical Ingredient (API) salts influence the solubility, stability, and hygroscopicity of pharmaceuticals and affect the final drug formulation.

Software-Assisted Identification of Metabolites

June 1, 2010

The speed and accuracy of software-assisted identification of metabolites can be further improved by combination with rule-based metabolite prediction software.

Heparin Characterization

June 1, 2010

Heparin is well-known as an anticoagulant, antithrombotic drug. Chemically, it is a linear polysaccharide that is derived from animal tissues. For some time it has been known that heparin is not a homogeneous substance; rather, it is a heterogeneous mixture of molecules ranging in molar mass from less than 5,000 to more than 30,000 Daltons.

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