Standards.
Identity is confirmed before a container is opened, the fill is assayed by two laboratories, and the release document is issued with the lot rather than after it.
How a lot is released.
A release is a decision, made by a named person, that a specific lot meets a standard set before the lot existed. The four steps below stand behind that decision, in order, for every lot that ships.
A standard does not move to let a lot through. A result is read once, not adjusted afterward, and a lot that fails its standard is quarantined and investigated. It is not reworked into a pass, and no limit is widened after the fact.
Incoming identity
Every container that arrives is checked against its own certificate before it is opened, then kept in quarantine until identity is confirmed in our own hands. A supplier’s paperwork is a claim, not a result. Identity is confirmed here before the container leaves quarantine.
Infrared comparison · Qualified reference · Quarantine holdCompounding to the standard
Every entry has a standard, set before a lot is ever prepared: what goes in, in what order, under what conditions, and what the finished lot has to measure. The batch record is opened against that standard, not against the last lot that happened to pass. It is signed at each step by the person doing the work and a second person confirming it, as the step happens.
Written standard · Batch record · Two signatures per stepIndependent assay
The filled lot is assayed for strength and related substances by high-performance liquid chromatography, and a lyophilized entry is tested for water content by the Karl Fischer method. Both results are then confirmed by a second, independent laboratory that is never told what result to expect. When the two results disagree, the lot does not move forward until the disagreement is investigated and resolved. A limit is never widened to let a result through.
HPLC · Karl Fischer · Independent laboratoryThe certificate travels with the lot
The certificate that ships with a lot carries its lot number, the figures measured against the standard, and the name of the person who signed the release. A retention sample from the same fill is kept for 24 months under its own storage condition. A question raised well after a lot has shipped can still be answered from the material itself, not from memory.
Certificate of analysis · Retention sample · 24 monthsIdentity testing and purity testing
Two different questions, answered by two different methods, in that order.
Purity: how much of the lot is one substance
A purity result states how much of a lot is one substance, measured against everything else present in it. It is reported as a chromatographic purity against a floor set for that entry, and it tells you how clean the material is.
Every entry carries the floor the material is released to. For a bulk substance that floor is a chromatographic purity by area percent; for a filled solution the release figure is the assay against label claim. A typical figure is a marketing number; a floor is a commitment.
Identity: which substance it is
A purity result does not tell you which substance that is. A peptide assembled with the wrong sequence can still measure high on a purity assay while being the wrong molecule entirely, so identity is confirmed separately, by a different physical method, before a purity number means anything.
For a peptide that is a mass measurement plus a peptide map. For a small molecule it is a chromatographic comparison against a qualified reference plus an infrared spectrum.
What ships with a lot
A lot that fails its standard does not reach this list, because it does not release.
Documents
Per lot · per entryIssued with every lot at release. Kept for the life of the account.
Issued per entry, at each revision. The current and the prior revision are kept.
Issued per entry, at each revision. The current revision is kept.
Issued per entry, on request. The current revision is kept.
Issued with every lot at fill. Kept for 24 months from fill.
Certificate of analysis
Specimen · Lot L-24309- Compound
- Glycine
- Presentation
- Solution, 100 mg/mL, sealed vial
- CAS
- 56-40-6
- Appearance
- Clear, colorless, free of visible particulate. Conforms.
- Identity
- Infrared absorption against a qualified reference. Conforms.
- Assay
- 99.7 percent of label claim at 100 mg/mL, against a range set for this entry.
- Chromatographic purity
- Not less than 99.5 percent.
- Second laboratory
- Independent assay agrees within method limits. Confirmed.
- Retention sample
- Held under the entry’s storage condition for 24 months from fill.
- Issued
- 14 Aug 2026
From the establishment to release.
A certificate of analysis is the manufacturer’s claim about a lot. It is filed, read, and checked against a result produced here. The check is what releases the container, and both documents stay with the lot from that point on.
Four points of record follow. A container is not released on the certificate it arrived with.
The establishment
Each entry is sourced from one manufacturing establishment that holds FDA registration. The registration belongs to the manufacturer, and it is a fact about the manufacturer: it is recorded on the source file and named on the lot record, never claimed as our own.
Single source per entryIncoming identity
A container arrives sealed, is logged into quarantine under its incoming lot number, and is identified here before it is opened for use. The supplier’s result is not the release criterion; ours is.
Confirmed on arrivalThe certificate, per lot
Every lot arrives with the manufacturer’s certificate of analysis: identity, assay and the impurity results it reports, against the manufacturer’s own specification. It is filed against the incoming lot and read beside the result produced here.
Filed against the lotRelease from quarantine
A container leaves quarantine when its identity is confirmed and the certificate agrees with what was found. The incoming lot number is carried onto the filled lot and onto the release document that ships with it.
Origin carried to releaseWhat an account can read about a lot’s origin.
Every document below is filed against the lot number and is open to the account that holds the lot.
The origin record
Per lotThe manufacturing establishment named on the lot record, and the fact of its FDA registration as it stands on the source file.
The manufacturer’s certificate of analysis for the lot, as received and unedited.
The method and the result recorded here before the container left quarantine.
The incoming lot number, the filled lot it became, and the release document issued against it.
Receipt, quarantine and release entries in sequence, with the temperature log where the material is shipped and held cold.
Why a certified material is identified again
A certificate describes the lot the manufacturer tested. Identity confirmed here proves that the container on the bench is that lot, and that nothing changed between the two sites. That is a smaller claim than a full assay, and it is the one that has to be settled before anything else is done with the material.
Traceability runs both ways
From a release document, the account can reach the incoming lot, its certificate and its establishment. From an incoming lot, the record shows every filled lot it went into. A question about origin is answered by a lookup, not by a call.
The regulatory basis for each entry.
One ground per substance, printed on the entry with the authority named.
A compounder may use a bulk drug substance on one of three grounds: an applicable USP–NF monograph; failing that, a component of an FDA-approved drug; failing both, the list FDA has established by regulation at 21 CFR 216.23. Each entry on the register prints the single ground it stands on, in that order. An entry that would need two grounds stacked together is an entry with no ground at all, and it is not presented that way.
Who may hold an account.
GradeBio verifies each organization before an account is opened, supplies clinical entries to be dispensed by the licensed pharmacy of record on a prescription, and supplies research entries to the institution named on the account. GradeBio does not dispense, does not prescribe, and does not sell to the public.
The classes that may hold one, what each may buy, and where it ships. The channel follows from the class, and no account is approved automatically.
Account classes
Class · buys · ships to · attests| Organization class | What it may buy | Where it ships | What it attests |
|---|---|---|---|
| 503A compounding pharmacy | Clinical entries Clinical · Rx only | The licensed pharmacy address on the account. | Licensed and in good standing; supply only on a valid prescription for an identified patient; no resale or transfer; the account’s legal entity is the buyer of record. |
| 503B outsourcing facility | Clinical entries whose entry states a basis under section 503B Clinical · Rx only | The registered facility address on the account. | Registered and in good standing; the entry ordered states a basis under section 503B, either FDA’s clinical-need list or the drug shortage list; supply for compounding under the facility’s own registration; no resale or transfer; the facility is the buyer of record. |
| Physician practice or clinic, including a med spa under a physician medical director | Clinical entries, dispensed by the pharmacy of record Clinical · Rx only | The licensed pharmacy of record named on the account. | Licensed and in good standing; every order signed by the prescriber of record; the buyer of record is the prescriber’s own professional entity; no clinical guidance is sought from GradeBio. A med spa is reviewed in writing. |
| Hospital or health-system pharmacy | Clinical entries Clinical · Rx only | The hospital pharmacy address on the account. | Licensed and in good standing; supply only on a valid prescription for an identified patient; no resale or transfer; the health system is the buyer of record. |
| Research institution or laboratory | Research entries only Research channel | The institutional address on the account. Never a residence, never a clinic. | Laboratory research only, not administered to humans or animals; received only at the institutional address; no resale or transfer; no protocol or guidance is provided by GradeBio. |
| Other licensed organization | Clinical entries, after written review Clinical · Rx only | The licensed address on the account. | Licensed and in good standing; supply only on a valid prescription for an identified patient; no resale or transfer; the organization is the buyer of record. |
The research channel.
Research channel The channel every research entry is supplied on, marked in the register, on its label and on its invoice.
What it is
A segregated channel on which certain entries are supplied as a research-use-only material to verified research institutions and laboratories: a university, an academic medical center, a contract research organization, an independent or government laboratory, or a biotech or pharmaceutical research group. The entries sit in the register beside every other entry, because they are part of what GradeBio supplies.
An account on this channel is opened against an institutional authorization and a named principal investigator, under the research attestation set. The label carries the research legend in the wording set out on the compliance page, with no prescription statement and no pharmacy‑of‑record line. The material ships only to the institutional address on the account.
What it is not
It is not a clinical supply. A research entry is never sold to a pharmacy, an outsourcing facility, a practice or a hospital, and a research account cannot buy a clinical entry. An entry that lists both channels is two separate supplies, each on its own attestation set and its own label.
It is not a source of instruction. GradeBio provides no protocol and no guidance for the use of any material on this channel; the institution’s own program governs what is done with it.
See what we release.
Every entry in the register, with the identifiers behind it and the certificate that ships with it.