Quantitative Estimation of Particulate Matter in Pharmaceutical Preparations Intended for Intravenous Administration

Bikhazi, Anwar B.; Shiatis, Joannis A.; Haddad, Ahmed Al

doi:10.1002/jps.2600660212

Cited by 6 publications

(5 citation statements)

References 8 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, this takes no account of shape or changes in resistivity between different particles [91]. This technique has been used extensively to count particles (1–1000 μm) in the pharmaceutical industry, especially to monitor the quality of intravenous solutions [92,93]. The technique is limited by the smallest available opening between the electrodes.…”

Section: Techniques To Analyse Insoluble Protein Aggregatesmentioning

confidence: 99%

Analytical techniques for the evaluation of liquid protein therapeutics

Tatford

Gomme

Bertolini

2004

Biotech and App Biochem

View full text Add to dashboard Cite

A common problem in the manufacture of liquid protein therapeutics is the tendency for aggregation and particle formation on extended storage. Analytical techniques are required to study the propensity of solutions to form aggregates and particles and to allow the investigation of the effect of conditions encountered during manufacture and storage. A key challenge is to utilize appropriate specific and sensitive techniques to allow the early detection of initial aggregation events, thereby avoiding the need to resort to extended stability trials. The present review evaluates a range of techniques for the detection of changes in protein conformation and the formation of aggregates and particles. It is hoped that the availability of this information will encourage and facilitate studies to resolve stability issues associated with protein therapeutics.

show abstract

Section: Techniques To Analyse Insoluble Protein Aggregatesmentioning

confidence: 99%

Analytical techniques for the evaluation of liquid protein therapeutics

Tatford

Gomme

Bertolini

2004

Biotech and App Biochem

View full text Add to dashboard Cite

show abstract

“…according to the authors, while only carbon black particles with sizes between 1 and 3 µm were identified in the 2G sample, carbon black, starch grains, lacquer flakes, and rubber with sizes up to 100 µm were found in the 2aL sample [2]. One product is within the specifications (2G) and the other is not (2aL).…”

mentioning

confidence: 95%

“…Bikhazi et al [2] reported a logarithmic relationship between the number of particles and their diameter in a solution. Bikhazi et al [2] reported a logarithmic relationship between the number of particles and their diameter in a solution.…”

mentioning

confidence: 99%

“…One product is within the specifications (2G) and the other is not (2aL). although glass and FIGURE 10.1 coordinate plot of log of number of particles oversize per milliliter versus log particle diameter for BP specifications [2]. Techniques for counting particulate matter allow a discrimination of the particles by sizes even lower than the pharmacopeial limits and, though not prescribed, it is also possible to characterize particulate matter by its composition.…”

mentioning

confidence: 99%

“…Key: (), product 2aL packed in 500-mL glass containers with lacquercoated rubber stopper; (), product 2G packed in 500-mL plastic bags; and smooth curve, BP specification [2]. Since the 1970s, there have been reports of FIGURE 10.2 cumulative particle size distribution in 5% dextrose solutions for injection.…”

mentioning

confidence: 99%

See 2 more Smart Citations