Analytics

Articles

Spectroscopy using light is a familiar technique and the electromagnetic spectrum from UV to IR is routinely employed. This article looks at the advantages and applications of spectroscopy using sound waves, with special reference to pharmaceutical research.

An Alternative Spectroscopy Technique for Biopharmaceutical Applications

Paul N. Schank is the senior computer validation engineer at Lockwood Greene Engineers, Somerset, New Jersey.

An all-electronic validation can provide storage costs savings and ensured document legibility.

E-Validation: A Method for Electronic Validation Protocol Generation, Approval, and Execution

A limit test using ion mobility spectrometry (IMS) has the potential to dramatically reduce the time required for cleaning verification and cleaning method development. The traditional approach to cleaning verification, often using HPLC, is relatively resource intensive and can lead to significant delays in reporting results. The main advantage of IMS is that results are seen virtually instantaneously, so any necessary re-measurement can be done very quickly. If the results demonstrate cleanliness, production can resume in a matter of hours not days.

IMS Limit Test Improves Cleaning Verification and Method Development

Paul Newton, PhD, is a technical project manager in the quality assurance department at GlaxoSmithKline, 1011 N. Arendell Ave., Zebulon, NC 27597, tel. 919.269.1730.

The author explains how a sponsor company can select and partner with a CRO for the redevelopment and revalidation of analytical test methods.

Upgrading Pharmaceutical Test Methods Using a Contract Research Organization

Ranga Velagaleti is the manager of laboratory and stability at BASF Corporation, 8800 Line Ave., Shreveport, LA 71106, tel. 318.861.8040, fax 318.861.8004, velagar1@basf-corp.com

The authors subjected ibuprofen bulk drug and tablet assay preparations to various stresses to evaluate the selectivity and specificity of the drug substance and product samples.

Forced Degradation of Ibuprofen in Bulk Drug and Tablets and Determination of Specificity, Selectivity, and the Stability-Indicating Nature of the USP Ibuprofen Assay Method

Saranjit Singh is a professor and head of the department of pharmaceutical analysis at the National Institute of Pharmaceutical Education and Research, Sector 67, S.A.S. Nagar 160062, India, tel. 91 172 214682, fax 91 172 214692.

K. Venugopal is a postgraduate student from the National Institute of Pharmaceutical Education and Research, Sector 67, S.A.S. Nagar 160 062, India, presently working at Ranbaxy Research Laboratories (Gurgaon, India).

Eventual change in the dissolution characteristics of some dosage forms, which is ascribed to cross-linking of gelatin, continues to present challenges to drug manufacturers. The authors discuss the causes, mechanisms, and solutions to the problem.

Alteration in Dissolution Characteristics of Gelatin-Containing Formulations: A Review of the Problem, Test Methods, and Solutions

Pam Anderson is a laboratory chemist at BASF Corporation.

Lynn Massad is a laboratory chemist at BASF Corporation.

Philip Burns is the manager of quality control at BASF Corporation.

This study investigated the effectiveness of the direct extraction of tablets and shaking time on the disintegration of tablets, solubilization, and recovery of ibuprofen from tablets of various formulations, strengths, and spiked placebo.

Validation Changes to the USP Assay Method for Ibuprofen Tablets

Darryl Roberts, PhD, Stephen Scypinski, PhD, Mary Oats, PhD, and Joseph Etse, PhD were chosen by the Analytical Research & Development Steering Committee of the PhRMA to draft the aceptable analytical practice guidance document.

Joseph Etse, PhD, Darryl Roberts, PhD, Stephen Scypinski, PhD, and Mary Oats, PhD, were chosen by the Analytical Research & Development Steering Committee of the PhRMA to draft the aceptable analytical practice guidance document.

Stephen Scypinski, PhD, Darryl Roberts, PhD, Mary Oats, PhD, and Joseph Etse, PhD were chosen by the Analytical Research & Development Steering Committee of the PhRMA to draft the aceptable analytical practice guidance document.

Mary Oates, PhD, Darryl Roberts, PhD, Stephen Scypinski, PhD, and Joseph Etse, PhD were chosen by the Analytical Research & Development Steering Committee of the PhRMA to draft the aceptable analytical practice guidance document.

This article presents the findings of PhRMA's annual workshop, held in September 2000, that convened to draft an acceptable analytical practice that would clarify the essential elements of a complete and compliant transfer.

Pharmaceutical Reserch and Manufacturers Association Acceptable Analytical Practice for Analytical Method Transfer

Because drug delivery at a zero-order rate provides uniform concentration of a drug for absorption, this study attempts to identify a simple mathematical method to quantitatively express the deviation from zero-order kinetics.

A Novel Mathematical Method for Quantitative Expression of Deviation from Zero-Order Drug Release

Appropriate sampling procedures, proper preparation, and correct instrumental parameters may yield differing, but correct, results.

Analytical Method Development