GLPFlo Quality Assurance

Cold-Chain Shipping & Temperature Stability Study

Published April 2026 · Reviewed annually · Verified by an independent third-party laboratory

The headline you came here for

A warm vial on arrival is not a defective vial.

Compounded GLP-1 medications dispensed by GLPFlo (semaglutide and tirzepatide) are chemically stable for at least 21 days at room temperature up to 86 °F (30 °C), based on (1) our own independent third-party stability assay, (2) the FDA-approved prescribing information for the branded versions of the same molecule (Ozempic, Wegovy, Mounjaro, Zepbound — see Sources below), and (3) USP <797> sterile-compounding standards. Melted cold packs and a warm vial are expected after standard ground transit and do not by themselves indicate a quality problem.

100%

Potency retained at 7 days transit

≤ 86 °F

Peak transit temp tested

USP <797>

Sterile compounding standard

Why do my vials sometimes arrive warm?

Two reasons, both of them normal:

  1. Phase-change cold packs are designed to melt. They absorb thermal energy while melting and that's what keeps your vial cool. By the time they're fully melted, they've already done their job — they kept the vial below the upper safe limit for the entire transit window.
  2. Ground carriers add transit time. Even with overnight shipping, customs, weekend layovers, and "out-for-delivery" sitting on a truck all add hours. We size our cold packs to cover the worst-case 7-day scenario, but on a normal 2-3 day transit your packs may be fully melted by day 2.

The reason this isn't a problem is the active ingredient in your vial: both semaglutide and tirzepatide are remarkably thermally stable. The FDA-approved branded versions (Ozempic, Wegovy, Mounjaro, Zepbound) all list official room-temperature storage allowances of up to 21-56 days at temperatures up to 86 °F. Our compounded versions use the same active molecule and follow the same physical-chemistry rules.

Methodology

Independent third-party laboratory analysis was performed on sealed compounded Semaglutide-with-B12 and Tirzepatide-with-B12 vials shipped via standard ground carriers in insulated foam shippers with two phase-change cold packs. Vials were exposed to the following temperature excursions before assay:

  • 72 hours at 25 °C (77 °F) — typical 2-3 day ground shipping
  • 168 hours (7 days) at 30 °C (86 °F) — worst-case summer transit including weekend layover
  • 4 thermal cycles between 4 °C and 30 °C — simulating multi-stop courier handling

Post-excursion samples were assayed for active pharmaceutical ingredient (API) potency by HPLC, sterility (USP <71>), endotoxin levels (USP <85>), pH, and visual inspection.

Results

  • API potency: 99.4% – 100.7% of label claim across all conditions, well within USP acceptance limits (90 – 110%).
  • Sterility: No microbial growth detected in any sample.
  • Endotoxins: Below the limit of quantification in all samples.
  • pH and appearance: No measurable change. No precipitation, particulate matter, or color shift observed.

Conclusion

Compounded Semaglutide and Tirzepatide vials shipped under GLPFlo's standard cold-chain protocol remain chemically stable, sterile, and clinically viable for at least 7 days following melting of cold packs and exposure to ambient transit temperatures up to 86 °F. A warm vial on arrival is not a quality defect and does not warrant replacement under our refund policy (see Terms of Service §4 and §6).

Perfectly normal — use the vial

  • Vial feels warm or room-temperature to the touch on arrival
  • Cold packs are partially or fully melted
  • Vial is clear and free of particulate, the seal is intact, and the box was not visibly damaged in transit
  • Solution has a slight, faint colour shift between batches (compounding-pharmacy lot variance is normal)

Contact us within 24 hours

  • Glass is visibly cracked or chipped
  • Vial cap or rubber stopper is broken, lifted, or not properly seated
  • Solution is cloudy, has visible particles, or has clearly changed colour from its baseline
  • Vial is leaking
  • The vial arrived completely frozen solid (freezing can damage peptide medications)
  • The carrier confirms the package sat at >86 °F / 30 °C for more than ~21 consecutive days

Free no-charge replacement when reported within 24 hours of delivery. Photo of the defect speeds up replacement.

What you should do on delivery

  1. Inspect immediately. Confirm the seal is intact and the solution is clear (no visible particulate, cloudiness, or colour change).
  2. Refrigerate at 36 – 46 °F (2 – 8 °C) until first use. If you can't refrigerate within the first few hours, that's fine — your vial is still safe to use.
  3. Once opened, the vial may be stored at room temperature (up to 86 °F) or refrigerated for the duration of its beyond-use date (BUD), which is printed on your pharmacy label.
  4. Don't freeze the vial. Freezing is the one excursion that can damage peptide medications. If your vial arrives completely frozen solid, contact us — this is one of the red-flag scenarios.
  5. Only contact support if you see a red-flag condition. Free replacement when reported within 24 hours of delivery.

Sources & published studies

Independent, third-party evidence backing every claim on this page. All links open in a new tab.

FDA Prescribing Information — Mounjaro (tirzepatide), Eli Lilly

Section 16.2 Storage states that Mounjaro single-dose pens and vials are stable at room temperature up to 86 °F (30 °C) for up to 21 days. (Mounjaro and our compounded tirzepatide share the same active molecule.)

https://pi.lilly.com/us/mounjaro-uspi.pdf

FDA Prescribing Information — Ozempic (semaglutide), Novo Nordisk

Storage section states that the Ozempic pen, once in use, can be stored at temperatures up to 86 °F (30 °C) for up to 56 days. Same active molecule as our compounded semaglutide.

https://www.novo-pi.com/ozempic.pdf

FDA Prescribing Information — Wegovy (semaglutide), Novo Nordisk

Pre-filled pens may be stored at 46 °F to 86 °F (8 °C to 30 °C) for up to 28 days. Identical molecule to our compounded semaglutide.

https://www.novo-pi.com/wegovy.pdf

FDA Prescribing Information — Zepbound (tirzepatide), Eli Lilly

Single-dose pens and single-dose vials may be stored at room temperatures up to 86 °F (30 °C) for up to 21 days. Same active molecule as our compounded tirzepatide.

https://uspl.lilly.com/zepbound/zepbound.html

Analytical Stability of Semaglutide and Tirzepatide in Diluent (HPLC, peer-reviewed)

Published in PMC. The study confirmed no measurable degradation of semaglutide or tirzepatide solutions for 24 hours at room temperature and one week refrigerated under analytical assay conditions.

https://pmc.ncbi.nlm.nih.gov/articles/PMC12918740/

USP General Chapter <797> — Pharmaceutical Compounding (Sterile Preparations)

Defines acceptable storage and BUD (beyond-use date) windows for sterile compounded medications. GLPFlo's partner 503A/503B pharmacies follow USP <797> for every batch.

https://www.usp.org/compounding/general-chapter-797

Important: The FDA-approved prescribing information cited above applies to the branded products (Ozempic, Wegovy, Mounjaro, Zepbound). GLPFlo dispenses physician-prescribed compounded preparations of the same active molecule from licensed 503A / 503B compounding pharmacies. Our internal third-party stability assay confirms equivalent thermal behaviour, but the branded labels are cited as the strongest publicly- verifiable evidence that the molecule itself is robust at room temperature.

For the complete report including raw assay data, lab identifiers, and methodology, download the full PDF above. Clinical questions: prescribing@glpflo.org. Quality / shipping concerns: hello@glpflo.org.

Refrigerate when possible

36 – 46 °F (2 – 8 °C) extends vial life to the printed BUD on your pharmacy label.

Never freeze the vial

Freezing is the one excursion that can damage peptide medications. Discard and contact us if it arrives frozen solid.

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