1. CFR 211.94, Drug product containers and closures.
2. Amikacin Sulfate Injection, 2016. https://www.fda.gov/Safety/Recalls/ucm514656.htm: FDA Recall.
3. ASTM C 1624-5 Standard Test Method for Adhesion Strength and Mechanical Failure Modes of Ceramic Coatings by Quantitative Single Point Scratch Testing (2015).
4. Accelerated extractable studies of borosilicate glass containers;Borchert;J. Parenter Sci. Technol.,1989
5. Optimization of a pharmaceutical freeze-dried product and its process using an experimental design approach and innovative process analyzers;De Beer;Talanta,2011