Peer-Review Research

Mar 02, 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.
Mar 02, 2014
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The extended-release performance of drug-loaded pellets manufactured by two methods, drug layering and direct pelletization, was compared.
Feb 02, 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).
Jan 02, 2014
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Different approaches for qualification of personnel for visual inspection of residues on equipment surfaces are reviewed.
Dec 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
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.
Nov 02, 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.
Oct 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors discuss a strategy for developing a risk-based approach for testing of elemental impurities in leachable studies.
Oct 02, 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.
Sep 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Vaporous hydrogen peroxide, used for sterilization and decontamination, is highly potent but presents implementation challenges.
Sep 02, 2013
Pharmaceutical Technology
The advantages of using an automated powder dispensing system in a ventilated balance enclosure for efficient handling and effective containment of potent compounds are discussed.
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