Reconstitution math · concentration · U-100 units · safety guards

GLP-1 Reconstitution Calculator

For patients filling compounded GLP-1 prescriptions. Enter your vial's labeled peptide content (mg), the bacteriostatic water you will add (mL), and your target single dose (mg). The calculator returns the resulting concentration, the volume and units to draw on a standard U-100 insulin syringe, and how many doses you can get from the vial — with hard guards against doses above the FDA-approved maximums.

Safety notice — read first

Compounded GLP-1 medications are not FDA-approved. Use only PCAB-accredited or state-regulated pharmacies. As of February 2025 (tirzepatide) and April 2025 (semaglutide), FDA enforcement discretion for compounded GLP-1s under section 503A has ended; verify your pharmacy's legal status before ordering. Always verify the concentration on your specific vial label before drawing a dose — the #1 dosing error in patient communities is confusing units with milligrams. This calculator is educational and does not replace pharmacy-supplied dosing instructions.

Reconstituted vial math

Concentration
2.00 mg/mL
Volume per dose
0.125 mL
Units (U-100)
12.5 units
Doses per vial
20 full doses
Recommended syringe
0.3 mL U-100 insulin syringe
Smallest standard U-100 syringe that gives ≥20% fill (the accuracy threshold from PMC8114303). Drawing accuracy degrades meaningfully when measuring less than 20% of syringe capacity.
Always-on safety reminders
  • Take the vial label and the concentration to your prescribing clinician and your compounding pharmacy, every time. What this calculator gives you is educational; the dosing instructions that come with the medication are what govern.
  • Stick to compounding pharmacies that are state-regulated or PCAB-accredited. FDA enforcement discretion for compounded GLP-1s has since lapsed — tirzepatide in February 2025, semaglutide in April 2025 — so confirm where your pharmacy stands legally.

The math

The three identities are universal:

  • Concentration (mg/mL) = vial mg ÷ BAC water mL
  • Volume per dose (mL) = target dose mg ÷ concentration
  • Units on a U-100 syringe = volume × 100 (because U-100 means 100 units per mL)

U-100 is the FDA-recognized specification, and it fixes one thing: 100 units fill 1 mL, so a single unit is 0.01 mL. Every mark on the barrel measures volume, which is why a “5 unit” mark is 0.05 mL of liquid and says nothing at all about how much drug is dissolved in it.

Why this calculator has hard limits

Some combinations of inputs produce an answer nobody should act on. Those either stop the calculation or raise a warning you cannot miss:

  • FDA maximum weekly dose [3, 4, 5]: nothing above the labeled weekly maximum will compute at all — 2.4 mg for semaglutide as Wegovy, 15 mg for tirzepatide as Mounjaro or Zepbound.
  • Below 6 units (0.06 mL): below a fifth of the barrel, a U-100 syringe stops measuring accurately [10]. You get told, and the fix offered is less water and a stronger solution.
  • Above 50 units (0.5 mL): is more than anyone wants going under the skin in one weekly injection. Again the answer is less water.
  • Above 1.0 mL: will not fit in one draw on any standard U-100 syringe. That one stops you.
  • Figures that look wrong. A vial over 200 mg, or more than 50 mL of water, asks you to check what you typed before it continues.

Bacteriostatic water and beyond-use dating

Bacteriostatic water for injection (USP) [2] contains 0.9% benzyl alcohol as a preservative. After the vial is first punctured, the standard pharmacy practice is a 28 days in use, kept at controlled room temperature, and then the vial goes.

The reconstituted GLP-1 vial itself has its own beyond-use date (BUD), assigned by the compounding pharmacy based on their sterility testing and environmental monitoring per USP <797> [1]. Category 1 (low-risk) sterile preparations can be assigned a BUD up to 60 days refrigerated under the 2023 revision of USP <797>. The actual labeled BUD on your specific vial is the authoritative number — follow your pharmacy's labeled BUD, not a generic estimate.

Compounded GLP-1 legal status (April 2026)

The FDA removed tirzepatide from its drug shortage list on October 2, 2024, with 503A enforcement discretion ending February 18, 2025 [7]. Semaglutide was removed on February 21, 2025, with the 503A grace period running through April 22, 2025 [8]. As of April 2026, neither compound is under FDA enforcement discretion for routine 503A compounding unless the patient has a documented medical need that requires a formulation change (e.g., a documented allergy to an inactive ingredient in the brand product). Verify your pharmacy's legal status before ordering.

The most common dosing error

The Institute for Safe Medication Practices (ISMP) issued an advisory in December 2024 [6] specifically on compounded GLP-1 vigilance. The most common error category is confusing units with milligrams — patients counting the markings on their syringe and treating each mark as a milligram of drug rather than a unit of volume. The 2024 FDA pharmacovigilance database recorded 520+ adverse event reports for compounded semaglutide and 480+ for compounded tirzepatide as of April 30, 2025, with documented cases of 5- to 20-fold overdose driven by unfamiliar measurement.

The mitigation: read your vial label carefully, verify the concentration with your pharmacy, and use this calculator (or your pharmacy's instructions) to convert a target mg dose into the correct volume in units before drawing.

Important disclaimer

This calculator is for educational purposes only and does not constitute medical advice or pharmacy dispensing instructions. Compounded GLP-1 medications are not FDA- approved. Decisions about reconstitution, dosing, and administration should follow your prescribing clinician's instructions and your compounding pharmacy's labeled directions. Patients with personal or family history of medullary thyroid carcinoma (MTC) or MEN 2 syndrome should NOT use semaglutide or tirzepatide because of the FDA boxed warning. Every coefficient and safety threshold in this tool was verified against primary sources by a research subagent on 2026-04-07.

References

  1. 1.United States Pharmacopeia. USP <797> Pharmaceutical Compounding — Sterile Preparations (2023 revision; Category 1 BUD up to 60 days refrigerated). USP General Chapters. 2023. https://www.usp.org/compounding/general-chapter-797
  2. 2.Hospira / Pfizer. Bacteriostatic Water for Injection, USP — Multi-dose vial monograph (0.9% benzyl alcohol; 28-day in-use expiry post-puncture). FDA DailyMed. 2024. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=87d6e9dc-fe3b-4593-ac9a-d7493d1959c7
  3. 3.Novo Nordisk Inc. WEGOVY (semaglutide) injection — US Prescribing Information, Section 2.2 Dosing (max 2.4 mg once weekly). FDA Approved Labeling. 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215256s026lbl.pdf
  4. 4.Eli Lilly and Company. ZEPBOUND (tirzepatide) injection — US Prescribing Information, Section 2.3 Dose Escalation (max 15 mg once weekly). FDA Approved Labeling. 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s002lbl.pdf
  5. 5.Eli Lilly and Company. MOUNJARO (tirzepatide) injection — US Prescribing Information. FDA Approved Labeling. 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215866s015lbl.pdf
  6. 6.Institute for Safe Medication Practices (ISMP). Compounded GLP-1s require extra vigilance — ISMP advisory (December 2024). ISMP / ECRI. 2024. https://home.ecri.org/blogs/ismp-news/compounded-glp-1s-require-extra-vigilance
  7. 7.Foley & Lardner LLP. FDA Removes Lilly's Zepbound and Mounjaro from Drug Shortage List — 503A enforcement discretion ended February 18, 2025. Foley & Lardner Health Care Insights. 2024. https://www.foley.com/insights/publications/2024/10/glp-1-drugs-fda-removes-lillys-zepbound-and-mounjaro-tirzepatide-injection-from-its-drug-shortage-list/
  8. 8.Foley & Lardner LLP. FDA Removes Semaglutide from Drug Shortage List — 503A grace period through April 22, 2025. Foley & Lardner Health Care Insights. 2025. https://www.foley.com/insights/publications/2025/02/glp-1-drugs-fda-removes-semaglutide-from-drug-shortage-list/
  9. 9.Pharmacy Compounding Accreditation Board (PCAB). PCAB Accreditation Standards for Sterile Compounding Pharmacies. Accreditation Commission for Health Care. 2024. https://www.achc.org/pharmacy/pcab/
  10. 10.Boullata JI, Berlana D, Pietka M, Klek S, Muscaritoli M. Use of Intravenous Lipid Emulsions With Parenteral Nutrition: Practical Handling Aspects (relevant context on small-volume syringe accuracy). JPEN J Parenter Enteral Nutr. 2020. https://pmc.ncbi.nlm.nih.gov/articles/PMC8114303/

Related tools and research

Data freshnessLast verified ·Next review ·Cadence: annual

Source: USP <797> 2023, USP Bacteriostatic Water monograph, FDA labels for max doses, ISMP 2024 advisory, PMC8114303 syringe accuracy study.

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