In the case that vaccine antigen is more stable at lower pH, how low the pH can go based on the experience of existing marketed vaccine products? Where to find the pH information of marketed vaccines?
Dear Cindy
For detailed requirements for injectable drugs please check pharmacopoeia. In general pH between 3 and 9 is accepted for injections, see examples:
Phenytoin (pH 12.0)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010151s036lbl.pdf
Furosemide (pH 8.0-9.3)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018579s029lbl.pdf
Vancomycin (pH 2.5-4.5)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/062931s018lbl.pdf
pH of approved vaccines you can find in accesdata FDA page or on labels see example (google search "ACAM2000" "label" "pH"):
Bexsero
https://vaccines.procon.org/sourcefiles/Bexsero-Package-Insert-2015.pdf
ACAM2000
https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm142572.pdf
Vaccines Licensed for Use in the United States
https://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm093833.htm
Best regards
Tomasz
To reduce the amount of stinging on an injection the pH should be between 6.8 and 7.2.-
- Badges
- Science topic
- Similar topics
- Biological Science
- Biochemistry
- Biochemical Techniques
- Analytical Chemistry
- pH