503Pharma stability consortium
NAD+ stability study.
Review the NAD+ 100 mg/mL preserved working formula and confirm whether your pharmacy can reproduce the formulation, process, and container-closure specifications.
Working formulation
Review the proposed MFR.
The current working MFR uses beta-NAD disodium salt as the candidate API. Member responses will determine which single API form and formulation advance to stability testing.
Formula components
NAD+ API, benzyl alcohol USP at 0.9% w/v, dilute HCl and/or NaOH for pH adjustment, and Sterile Water for Injection USP.
One formulation will advance
Please identify whether your pharmacy currently sources NAD+ free acid, NAD+ disodium salt, both, or another form. The consortium will select one API form based on member sourcing and reproducibility responses; this is not a proposal for parallel stability studies.
Laboratory study plan
Stability testing over time.
The testing laboratory will store and evaluate study samples under three controlled conditions.
| Study arm | Laboratory condition | Scheduled evaluation |
|---|---|---|
| Controlled room temperature | 25 ± 2°C 60 ± 5% RH | Day 0 baseline; Day 30 assay / ID |
| Refrigerated | 2-8°C | Shared Day 0 baseline; Day 45 and Day 90 testing |
| Frozen excursion | -20°C | Shared Day 0 baseline; Day 30 assay / ID |
What the laboratory will evaluate
The study follows chemical, physical, microbiological, and package-integrity indicators over time.
Pharmacy response
Review and respond.
Tell us which NAD+ form you source, what you can match, and what would need to change.