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Semax free base: Semax free base. What its COA has to show.

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

Semax free baseAs Appendix B prints it

Amino acid sequence

Molecular formula
C37H51N9O10S
Molecular weight
813.9 g/mol
Amino acids
7

Dosage forms Appendix B covers

Subcutaneous (not covered)Intramuscular (not covered)Oral (not covered)Topical (not covered)Intranasal

One of six. See all six.

What a Semax free base COA has to show under HHS's peptide policy.

Semax 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 Semax apart

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

The only free base. Appendix B names Semax as the free base and covers "semax free base". The other five are acetates.

The only intranasal form. It is covered for "intranasal use", a route Appendix B names for no other peptide.

No counter-ion to report. With no acetate, the counter-ion row of the testing table does not apply, in our reading.

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-Met-Glu-His-Phe-Pro-Gly-Pro-OH, 7 amino acids, the formula as C37H51N9O10S and the weight as 813.9 g/mol. The card at the top of this page sets them out.

The form. Appendix B names Semax as the free base, C37H51N9O10S, 813.9 g/mol. A COA for a salt of Semax, such as an acetate, describes a different form. 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: "Semax 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 both forms."

The dosage forms it covers

Appendix B covers semax free base for "intranasal use".

Intranasal use. Note 4: "If the BDS is intended for incorporation into an alternative dosage form, the appropriate quality tests specific to that dosage form should be conducted and the results reported on the COA."

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 Semax with another peptide or another active ingredient.

Other forms. Appendix B lists no injectable, oral or topical form for Semax.

The tests its COA reports

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

12 apply2 depend on the lot6 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

  • BioburdenDepends. Note 4 ties it to injectable forms and asks, for Semax's intranasal forms, for the quality tests specific to them. We still look for a microbial count.
  • Bacterial endotoxinsDoes not apply. Note 4 ties it to injectable forms, and Appendix B covers no injectable form of Semax.

Depends on the peptide6

  • Counter-ion contentDoes not apply. Semax is the free base, so there is no counter-ion to measure.
  • Higher order structureDoes not apply. Semax has 7 amino acids; the table sets this for complex peptides of 8 or more.
  • AggregatesDoes not apply. Semax has 7 amino acids; the table sets this for complex peptides of 8 or more.
  • Biological activity / bioassaysDoes not apply. Semax has 7 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 Semax'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 Semax COA comes in. It follows from the lines above; it is not a rule of HHS or the FDA.

  1. The form

    The COA describes the free base, as Appendix B names it.

  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 Semax 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.