GradeBio Sheet G‑03.11  /  Biotin, specification G‑03.11Rev. A
GradeBio Entry 11 · specification
Sheet G‑03.11
Revision A  ·  01 Sep 2026

Biotin.
The systematic name
on file, at 5 mL per mL.

Biotin is registered under its full systematic name, Hexahydro-2-oxo-1H-thieno[3,4-d]imidazole-4-pentanoic acid, as a sterile aqueous solution at 5 mL to the millilitre.

The name is long because the molecule is a fused bicyclic ring system carrying a pentanoic acid side chain; the identity test compares the whole structure, not a fragment of it.

CAS
58-85-5
Molecular formula
C10H16N2O3S
Average mass
244.31 g/mol
Presentation
Solution, 5 mg/mL
Assay floor
≥ 98.5 %
Label class
P  ·  physician use, prescription
Structure  Hexahydro-2-oxo-1H-thieno[3,4-d]imidazole-4-pentanoic acid
Biotin, a clear, colorless solution, free of visible particulate in a sealed glass vial.
Plate 1   Entry 11 as filled. A 5 mL solution fill, sealed, specimen photography.

Grade Bio  /  Register  /  Entry 11  /  Sheet G‑03.11

1.0

What this is

Identity and presentation

The assay floor is ≥ 98.5 %, run against a reference standard.

It ships as a clear, colorless solution, free of visible particulate, filled at 5 mL and sealed.

Class P labelThe vial and its carton carry FOR PHYSICIAN USE ONLY Rx ONLY and the prescription legend. No pharmacy name is printed on the label: dispensing runs through more than one licensed partner, and the pharmacy of record is disclosed at the point of dispensing, not printed in advance.
Not on this sheetNo dose, no schedule, no route, no protocol and no preparation direction. Those are clinical decisions and they belong to the prescriber and the dispensing pharmacist, not to the company that made the material.
2.0

Specification

Released against the figures below, lot by lot

Every attribute below is checked against a fixed specification before a lot is released. The result column shows specimen lot L‑24309. A lot that misses a line is not released, and the register entry is marked rather than the sheet edited.

AttributeMethodSpecificationResult
AppearanceVisualClear, colorless solution, free of visible particulateConforms
IdentityRP‑HPLC vs referenceConforms to referenceConforms
Assay, purityRP‑HPLC≥ 98.5 %Conforms
Presentation, fillGravimetricSolution, 5 mg/mL (5 mL fill)Conforms
Table 2.1   Biotin · specification and specimen result, lot L‑24309.
3.0

Storage and retention

How it is held
Storage
2 to 8 °C
Light
Protect from light
In use
Do not freeze
Container
5 mL vial (ISO 8362-1, 6R)
Retained sampleA sample of every lot is held under the storage condition above, so a question can be answered from the material itself rather than from memory.
4.0

Documents behind this lot

What an account can pull
DocumentNo.What it shows
Certificate of analysisGB‑101Every attribute in table 2.1, the method, the specification and the measured result, signed on release.
Identity data packageGB‑104The reference chromatogram the lot was compared against.
Method summaryGB‑110The analytical methods named in table 2.1, with their validation state.
Stability summaryGB‑118The data the storage condition rests on.
Lot genealogyGB‑140Raw material lot, fill date, container closure lot, and the release signature.
Table 4.1   A verified account can pull these against any lot it holds.
5.0

How it reaches a patient

The pharmacy of record does the dispensing

Grade Bio does not dispense and does not ship to a patient. Material is supplied only pursuant to a valid prescription for an individually identified patient, and it is dispensed by the licensed pharmacy of record named on the account. The practitioner writes the prescription. The pharmacy fills it. We supply the material and the paperwork that proves what it is. Sheet G‑07 sets out the whole route.

GradeBio

Grade Bio is a brand of Mountain Brands LLC. Entity formation is pending and no registration has been filed. Correspondence to jv@gradebio.com or sw@gradebio.com.

Pre‑launch document Entity pending

The register

The company