S-04 · Stability & shelf-life
Shelf-life you can defend.
ICH Q1A-aligned stability programmes. We store, pull, test, and trend — you receive interval reports and a final shelf-life recommendation, both defensible under regulatory review.
Interval
0 / 3 / 6 / 12 mo
Conditions
25 °C / 40 °C
Sample req.
Protocol-scoped
Deliverable
Trending report
Method reference
MA-S04-STAB-01
Instrument-calibrated● ValidatedSigned releaseRaw data retained
Method sheetHK · Kwun Tong
§ 01 — Assay scope
What is measured.
Every attribute is quoted, run, and reported against the same reference method. Add-ons run from the same submission.
A-01ICH Q1A
Long-term storage
25 °C / 60% RH — the reference condition for ambient-stable products.
A-02ICH Q1A
Accelerated
40 °C / 75% RH — six-month accelerated pulls for shelf-life projection.
A-03ICH Q1A
Refrigerated
5 °C ± 3 °C for cold-chain peptides and biologics.
A-04ICH Q1B
Photostability
ICH Q1B-aligned photostability screening on request.
§ 02 — Method sheet
MA-S04-STAB-01
Abbreviated method sheet. Full validated method (linearity, robustness, system suitability) available under NDA.
Method code
MA-S04-STAB-01
Chambers
Binder KBF · monitored 24/7, calibrated quarterly
Excursion policy
Any excursion > 2 °C / 5% RH triggers deviation log
Pull intervals
0, 3, 6, 9, 12 mo (long-term) · 0, 3, 6 mo (accelerated)
Assays per pull
Purity (HPLC), identity (LC-MS), moisture (KF), appearance
Reference
ICH Q1A(R2) · Q1B · Q1E (shelf-life extrapolation)
Reporting
Interval CoA per pull · trending report at study close
§ 03 — Deliverable
A certificate you can hand to a regulator.
- Interval CoA delivered within 5 business days of each pull
- Chamber-condition log attached to every interval report
- Trending report with regression, 95% CI, and shelf-life projection
- Deviation log with QA sign-off — no silent excursions
- Full study package archived 10 years, exportable at any time