Abstract:
:The delamination of glass contact surfaces because of hydrolytic instability has been well documented. However, the lack of glass surface integrity can also lead to other undesirable outcomes prior to visible glass delamination. This work shows how the early stages of delamination, namely, glass corrosion, can influence the chemical stability of active pharmaceutical ingredient (API) solutions contained within a glass container, even prior to the observation of visible delamination. Multiple containers, all constructed of glass classified as USP Type I, were evaluated for hydrolytic stability and how they influence the chemical stability of the API in question. The glass composition of these analytical consumables, the vendor source, and presumably manufacturing process were examined. The implications of glass container durability on product development decisions, the influence on analytical results, and the practice of like-for-like glass container interchangeability are considered.
journal_name
J Pharm Scijournal_title
Journal of pharmaceutical sciencesauthors
Watkins MA,Iacocca RG,Shelbourn TL,Dong X,Stobba-Wiley Cdoi
10.1002/jps.24069subject
Has Abstractpub_date
2014-08-01 00:00:00pages
2456-63issue
8eissn
0022-3549issn
1520-6017pii
S0022-3549(15)30484-6journal_volume
103pub_type
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