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Epitalon acetate: Epitalon acetate. What its COA has to show.

Epitalon in HHS's peptide policy: its identity, the dosage forms covered, and the tests its certificate of analysis reports. Last reviewed November 11, 2026.

Epitalon acetateAs Appendix B prints it

Amino acid sequence

Molecular formula
C14H22N4O9·CH3COOH
Molecular weight
450.40 g/mol
Amino acids
4

Dosage forms Appendix B covers

SubcutaneousIntramuscularOral (not covered)Topical (not covered)Intranasal (not covered)

Injectable forms only when "dispensed in intermittent courses". One of six. See all six.

What a Epitalon acetate COA has to show under HHS's peptide policy.

Epitalon is one of the six peptides in Appendix A of HHS's peptide policy. Appendix B prints its identity, covers it for set dosage forms, and sets the tests its certificate of analysis reports.

This page sets those lines out so a COA can be read against them. The ten conditions are on the policy page.

Reviewed November 11, 2026. Quotations are the source's own words: the policy's, or the Federal Register notice's where the page says so. Where this page gives our practice, it says so; that part is Veritura's reading, not a rule of HHS, the FDA or a board.

What sets Epitalon apart

Three things on its lines in Appendix B that the other five do not share.

A condition on dispensing. Epitalon is the only one of the six whose coverage carries a dispensing condition: injectable forms "that are dispensed in intermittent courses".

Four amino acids. The second shortest sequence of the six, after KPV. The tests for complex peptides of 8 amino acids or more do not apply.

Injectable forms only. Subcutaneous and intramuscular, so bioburden and bacterial endotoxins, which note 4 calls critical quality attributes of injectable forms, apply to every lot.

Identity, as Appendix B prints it

Condition 2 asks for "the identity and limitations in route of administration described in Appendix B." "The identity includes but is not limited to amino acid sequence, chemical structure, molecular weight, and molecular formula."

Appendix B prints the sequence as H-Ala-Glu-Asp-Gly-OH, 4 amino acids, the formula as C14H22N4O9·CH3COOH and the weight as 450.40 g/mol. The card at the top of this page sets them out.

The form. Appendix B prints Epitalon as the acetate, C14H22N4O9·CH3COOH, 450.40 g/mol. A COA that gives the formula without the acetate, or the free peptide's weight, does not match those lines. In our reading that is a discrepancy to settle with the supplier before the lot is used.

Its history. Appendix B gives it in one sentence: "Epitalon was in Category 2 from September 29, 2023, until April 22, 2026, and neither the placement nor the removal changed its status under section 503A; CDER recommended against listing either form, and the PCAC voted in favor of inclusion."

The dosage forms it covers

Appendix B covers epitalon acetate for "subcutaneous or intramuscular injectable dosage forms that are dispensed in intermittent courses".

Injectable forms. Condition 9: the only drug delivery device co-packaged with or containing the preparation is "an FDA 510(k)-cleared syringe." Note 4 names bioburden and bacterial endotoxins as "Critical Quality Attributes (CQAs) specific to injectable dosage forms".

Intermittent courses. Appendix B covers epitalon acetate for injectable forms "that are dispensed in intermittent courses". In our reading, the prescription and the dispensing record are where that shows.

One active ingredient. Condition 7: "The compounded drug product contains only a single Active Pharmaceutical Ingredient (API) listed in Appendix A." In our reading, that rules out a blend of Epitalon with another peptide or another active ingredient.

Other forms. Appendix B lists no oral, topical or intranasal form for Epitalon.

The tests its COA reports

The test names are the policy's. Whether each one applies to Epitalon acetate is our reading of the table's own qualifiers. The full table, with methods and references, is on the Appendix B page.

15 apply1 depend on the lot4 do not apply

Listed for every peptide12

  • Physicochemical propertiesApplies. By orthogonal methods from the policy's Table 1.
  • Identification / primary sequenceApplies. By at least two independent methods (note 3), "verified to be the BDS listed in this guidance".
  • AssayApplies. HPLC or RP-HPLC against a quantitative reference standard.
  • ImmunoassayApplies. Listed for every peptide, with no qualifier.
  • Peptide content (net)Applies. Amino acid analysis, nitrogen, UV or qNMR.
  • Peptide-related impuritiesApplies. Specified, unspecified and total, against ICH Q3A.
  • Residual solventsApplies. Gas chromatography, against USP <467>.
  • Elemental impuritiesApplies. ICP-MS, against USP <232> and <233>.
  • Residual TFAApplies. Ion chromatography.
  • Residual fluorideApplies. Ion-selective electrodes.
  • Water contentApplies. Karl Fischer titration.
  • Nitrosamine impuritiesApplies. Small-molecule nitrosamines are listed with no qualifier; NDSRIs "when applicable (in the presence of secondary, tertiary, or quaternary amines)".

Tied to injectable forms2

  • BioburdenApplies. Every form Appendix B covers for Epitalon is injectable.
  • Bacterial endotoxinsApplies. Every form Appendix B covers for Epitalon is injectable.

Depends on the peptide6

  • Counter-ion contentApplies. Epitalon is the acetate, and the table asks for acetate content.
  • Higher order structureDoes not apply. Epitalon has 4 amino acids; the table sets this for complex peptides of 8 or more.
  • AggregatesDoes not apply. Epitalon has 4 amino acids; the table sets this for complex peptides of 8 or more.
  • Biological activity / bioassaysDoes not apply. Epitalon has 4 amino acids; the table sets this for complex peptides of 8 or more.
  • Host cell-related impuritiesDepends. Only for a recombinant product. The supplier can say how the lot was made.
  • Thiol groupsDoes not apply. Required only if cysteine is present, and Epitalon's sequence has none.

Each result carries its method number and the number of its validation or verification report (note 2).

Where we look twice

Our practice when a Epitalon COA comes in. It follows from the lines above; it is not a rule of HHS or the FDA.

  1. The form

    The formula and weight are the acetate's, as Appendix B prints them.

  2. The dosage form

    Note 1 asks the COA for "a statement of purpose (i.e., intended dosage form, such as injectable, oral, etc.)". For Epitalon it is one of the forms above.

  3. The maker

    Note 1 asks for the "Manufacturer's corporate name, its FDA Establishment Identification (FEI) number, address". Condition 4 puts the plant's physical location on the COA.

  4. The methods

    Each result has a method number and a report number beside it, and identification rests on two methods.

Where the policy stands

As of November 11, 2026.

HHS announced the policy in the Federal Register on October 30, 2026, in FR Doc. 2026-22192. The notice says "HHS is announcing the availability of a draft" policy, and that "Written comments can be submitted until 2 weeks after date of publication in the Federal Register via regulations.gov on Docket No. HHS-OASH-2026-0496". It also says the policy "does not establish any rights for any person and is not binding on HHS or the public."

The policy calls itself an interim policy, and says: "HHS may revisit application of this interim policy (in whole or in part) if, among other things, a safety signal or product quality issue arises with a compounded drug product within the scope of this policy."

It does not put the six peptides on the 503A bulks list. The notice says the FDA's future rulemakings "may propose adding some or all of these peptides to the 503A bulks list based on the available evidence." For the current text, the notice points to the HHS website "to find the most current version of the policy."

Sources

Every source below was opened and read for this page. Last reviewed: November 11, 2026.

We read documents. We do not test material.