Regulatory monographs in Europe and the United States require drug products for parenteral
administration to be “practically free” or “essentially free” of visible particles, respectively. …

Measurement and characterization of subvisible particles (including proteinaceous and non-proteinaceous
particulate matter) is an important aspect of the pharmaceutical development …

Visible particles are a critical quality attribute for parenteral products and must be monitored.
A carefully designed, executed, and controlled drug product manufacturing process …

Meningococcal polysaccharides are medically important molecules and are the active
components of vaccines against Neisseria meningiditis serogroups A, C, W135, and Y. This study …

An LC–MS/MS method for determination of the break down product of N-ethyl-N′-(3-dimethylaminopropyl)
carbodiimide (EDC) urea derivative, EDU, has been developed and …

A new analytical method has been developed for the quantitative determination of ethylene
glycol‐containing nonionic surfactants, such as polyethylene glycol 8000, polysorbate 80, …

Glass prefillable syringes are lubricated with silicone oil to ensure functionality and a consistent
injection for the end user. If excessive silicone is applied, droplets could potentially result …

Visible particles must be monitored as part of the control strategy for pharmaceutical
products. Extraneous (foreign) particles are not acceptable in parenteral drug products. In …

ICH Q5C is relatively clear in terms of the logistics for a typical stability study. This chapter
focuses on the typical questions/ambiguities encountered during the design and conduct of …

Hydrogen peroxide has been used to cleave the native Neisseria meningiditis polysaccharide
(PS) from mega-Dalton molecular weight to a smaller size (∼20 kDa) depolymerized …