Peer-Reviewed Research - Pharmaceutical Technology

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PharmTech Europe

Peer-Reviewed Research

Through-Vial Impedance Spectroscopy: A New In-Line Process Analytical Technology for Freeze Drying

April 2, 2014

Pharmaceutical Technology

A new process analytical technology based on impedance spectroscopy has potential applications for characterizing product attributes during the freeze-drying process.

Comparing Drug Layering and Direct Pelletization Processes

March 2, 2014

Pharmaceutical Technology

The extended-release performance of drug-loaded pellets manufactured by two methods, drug layering and direct pelletization, was compared.

A New Approach to Forced Degradation Studies Using Anhydrous Conditions

March 2, 2014

Pharmaceutical Technology

In this article, the authors demonstrate that a normal-phase chromatographic method was stability-indicating for a water-sensitive prodrug. The stress conditions using aqueous and non-aqueous conditions were also compared to understand the information obtained with each approach.

Determination of Related Substances in Pemetrexed Disodium (Form-IV) in Bulk Drug Samples by HPLC

February 2, 2014

Pharmaceutical Technology

The authors describe the development of a stability-indicating reverse-phase high-performance liquid chromatographic (RP?HPLC) method for the quantitative determination of potential genotoxic impurities present in pemetrexed disodium (form-IV). The chromatographic separation was achieved on a RP?HPLC column (Zorbax SB-Phenyl, Agilent) at ambient temperature with gradient elution using mobile phase A (trifluoroacetic acid [TFA] in water) and mobile phase B (TFA in acetonitrile).

Qualifying Personnel to Visually Inspect Cleaned Equipment

January 2, 2014

Pharmaceutical Technology

Different approaches for qualification of personnel for visual inspection of residues on equipment surfaces are reviewed.

Establishing a Minimum Incubation Time for Biological Indicators

December 2, 2013

Pharmaceutical Technology

The industry lacks an accepted method for establishing a minimum incubation time (MIT) of less than seven days for biological indicators (BIs). The authors propose an MIT method that provides a means for reproducible determination of BI grow-out time.

Predicting Long-Term Storage Stability of Therapeutic Proteins

November 2, 2013

Pharmaceutical Technology

Predicting long-term storage stability of a given protein and formulation is desirable for effective screening and optimization early in the development process. Multiple routes to aggregation during storage to suggest that multiple measurement types should be made to probe different aspects of protein behavior.

A Risk-Based Approach to Monitoring Elemental Impurities in Leachable Studies

October 2, 2013

Pharmaceutical Technology

The authors discuss a strategy for developing a risk-based approach for testing of elemental impurities in leachable studies.

Ruggedness of Visible Residue Limits for Cleaning-Part III: Visible Residue Limits for Different Materials of Construction

October 2, 2013

Pharmaceutical Technology

The authors evaluated a variety of materials of construction (MOCs) and found that visible residue limits (VRLs) were higher on some MOCs than on stainless steel. The optimal viewing conditions were dependent on the MOC and the viewing background. The risk of a cleaning failure due to visual failure for different MOCs can be mitigated or eliminated using complementary cleaning validation studies.

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