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hypotheticalresearch-stagemicrodosepsilocybincGMP

Standardized Microdose Capsule — 2 mg

Research-stage spec for a federally-compliant 2 mg psilocybin capsule, manufactured under cGMP.

Hard rule — Schedule I controlled substance

This is NOT a product. It is engineering documentation.

Psilocybin is Schedule I under the U.S. Controlled Substances Act. We do not sell, distribute, or market this product. The specification on this page exists to document what such a product would look like if/when the regulatory pathway permits. The email waitlist below is purely for opt-in notification if/when that happens — it is not a pre-order, and we will never accept payment for a Schedule I substance.

Product description

Hypothetical product specification for a 2 mg psilocybin microdose capsule, designed for the eventual regulatory pathway under which functional doses below 5 mg may become permissible (Oregon Measure 109 service-center model, hypothetical FDA Schedule III rescheduling, or hypothetical state-by-state therapeutic-use frameworks). The formulation is hard-shell vegetarian capsule, size #4, containing 2.0 mg ± 5% psilocybin from cultivated Psilocybe cubensis fruit body, blended with microcrystalline cellulose carrier. Standardization is achieved via HPLC-MS analysis of every production lot to ensure dose accuracy. Uniform dosing is the central engineering problem of microdose product design — without it, the product is indistinguishable from raw mushroom material. This spec exists primarily to demonstrate that the platform has thought through what a real, lab-quality, FDA-compliant microdose product looks like — with proper analytical chemistry, cGMP manufacturing, and stability testing. It is NOT for sale. It is NOT being marketed. It is a conceptual reference for partners and customers to understand what science-backed psychedelic-medicine products look like, in case the regulatory environment ever shifts. Waitlist signup below — you'll be notified by email if/when this product (or a similar one) becomes legally available. We will never spam, never share your email, and never charge anything until we have a real product on a real shelf with real lab results.

Spec sheet

Product class
Encapsulated standardized microdose
Active compound
Psilocybin (4-PO-DMT)
Form factor
Hard-shell vegetarian capsule, size #4
Dose / serving
2 mg
Range studied
0.55 mg

Manufacturing notes

Cultivated under sterile conditions, harvested at consistent maturity, dehydrated to <5% moisture, ground to 200-mesh, blended with MCC carrier, encapsulated under cGMP. Active compound concentration verified by HPLC-MS on every lot (target ±5% from label claim). See /mushrooms/research/extraction for the full extraction-method analysis.

QA / testing protocol

  • [1]HPLC-MS quantification of psilocybin + psilocin per lot
  • [2]Microbial contamination testing (USP <61>) — total plate, yeast/mold, E. coli, Salmonella
  • [3]Heavy metal panel (USP <232>) — lead, arsenic, cadmium, mercury
  • [4]Dissolution testing per USP <711> — capsule integrity, release profile
  • [5]Stability study at 25°C/60% RH and 40°C/75% RH — 6 mo accelerated, 24 mo real-time
  • [6]Identity confirmation via UV spectroscopy at 269 nm

Regulatory pathway

Currently psilocybin is Schedule I under the Controlled Substances Act (1970). Therapeutic-use pathways are emerging: Oregon Measure 109 (2020) created licensed service centers for adult psilocybin use; Colorado Proposition 122 (2022) decriminalized natural psychedelics. Federal rescheduling to Schedule III has been discussed at HHS but not enacted. This product is designed to slot into a hypothetical Schedule III framework with cGMP manufacturing requirements; until that framework exists, no commerce is possible.

References

  1. [1] Polito, V. & Stevenson, R.J. (2019). A systematic study of microdosing psychedelics. PLoS ONE, 14(2), e0211023.(2019)doi:10.1371/journal.pone.0211023
  2. [2] Anderson, T. et al. (2019). Microdosing psychedelics: personality, mental health, and creativity differences in microdosers. Psychopharmacology, 236(2), 731-740.(2019)
  3. [3] Carhart-Harris, R.L. et al. (2016). Psilocybin with psychological support for treatment-resistant depression. Lancet Psychiatry, 3(7), 619-627.(2016)

Newsletter

Email me if/when this becomes legal commerce

Schedule I substance. We'll only contact you if the regulatory pathway opens. No commerce, no pre-orders, no payment.