Peer-Review Research

Aug 02, 2016
Pharmaceutical Technology
This paper describes a unique Prep-RP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).
Jul 02, 2016
Pharmaceutical Technology
The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.
Jun 02, 2016
Pharmaceutical Technology
This article presents recommendations based on a program that was set up to qualify members of a large, diverse team at one oral solid-dosage-form manufacturing facility.
May 02, 2016
Pharmaceutical Technology
This article examines using experimental design methods to define different procedures for intermediate bulk container cleaning. The authors have evaluated this new approach, in which a highly soluble, low-dose product and a relatively insoluble high-dose product constituted experimental input variables.
Apr 02, 2016
Pharmaceutical Technology
Visible residue limits have been shown to be a valuable tool in validated cleaning validation program.
Apr 02, 2016
Pharmaceutical Technology
The authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.
Apr 01, 2016
Pharmaceutical Technology
A strengths, weaknesses, opportunities, and threats analysis for an Eco-Friendly Pharmaceutical Production Facility in Malta.
Mar 02, 2016
Pharmaceutical Technology
A statistical approach determines when a statistically significant relationship between a process parameter and a critical quality attribute is large enough to make a practically meaningful impact.
Feb 01, 2016
Pharmaceutical Technology
A novel method, based on differential calculus, was used to calculate the maximum potential error associated with the drug concentration in pharmaceutical mixtures composed of an infinite number of ingredients measured on an infinite number of balances with different sensitivities. The method was further applied to calculate the ingredients’ least allowable quantities. This approach ensures that the pharmaceutical formulation is prepared within a given maximum permissible error in drug dose.
Jan 02, 2016
Pharmaceutical Technology
The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.
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