Hydroxocobalamin
Solution, 1 mg/mL, 5 mL fill in a 5 mL vial, sealed.
Presentation
What is in the vial, how much, and how it is sealed.
The molecular formula carries a cobalt atom, which is what the identity test is anchored on.
Hydroxocobalamin is supplied here as a sterile aqueous solution at 1 mg to the milliliter.
It ships as a clear, deep red solution, free of visible particulate, filled at 5 mL and sealed, and because the corrin ring is light sensitive, light sensitive. Keep in the carton until use..
As filled
Standard GB‑13Identity is settled before purity.
Which substance it is, and how much of the lot is that substance.
Identifiers
Per entry- CAS
- 13422-51-0
- Formula
- C62H89CoN13O15P
- Average mass
- 1346.4 g/mol
- Structure
- Cobalamin, hydroxo, vitamin B₁₂ form
- Assay floor
- ≥ 98.5 %
The cobalt‑hydroxo bond occupies the coordination site methylcobalamin fills with a methyl group instead, and it is also why the solution reads as clear, deep red solution, free of visible particulate: the color sits in the corrin ring itself, not in an additive.
Identity is confirmed before we open a container. Purity is measured after. A purity result says how much of the lot is one substance; an identity result says which substance that is. A wrong molecule can measure high on purity, which is why the two are never the same test.
Every line has a method and a limit.
A lot that misses a single line is not released.
Release specification
Specimen · Lot L‑24309| Attribute | Method | Specification | Result |
|---|---|---|---|
| Appearance | Visual | Clear, deep red solution, free of visible particulate | Conforms |
| Identity | RP‑HPLC vs reference | Conforms to reference | Conforms |
| Assay, purity | RP‑HPLC | ≥ 98.5 % | Conforms |
| Presentation, fill | Gravimetric | Solution, 1 mg/mL (5 mL fill) | Conforms |
Documents
Per lot · per entryEvery attribute in the release table, the method, the limit and the measured result, signed on release.
The reference chromatogram the lot was compared against.
The analytical methods named in the release table, with their validation state.
The data the storage condition rests on.
Raw material lot, fill date, container closure lot, and the release signature.
FOR PHYSICIAN USE ONLY · Rx ONLY
Dispensed pursuant to a valid prescription. As printed on the vial and the carton. No pharmacy name appears on the label — the pharmacy of record is disclosed when it dispenses, not in advance.
Storage is printed on the vial.
The condition on the label, the condition once in use, and the container.
Conditions
As labeledThe storage condition is printed on the vial and on the carton, and the stability summary is the data behind it. The in‑use condition applies from the moment the seal is broken.
Every container is quarantined until we confirm what it is. A supplier’s certificate is a claim, not a result. Nothing leaves quarantine on a claim.
This entry stands on one authority.
Your pharmacy of record dispenses it.
GradeBio does not dispense and never ships to a patient. Material is supplied only on a valid prescription for an individually identified patient, and your pharmacy of record dispenses it. You write the prescription. The pharmacy fills it. We supply the material and the paperwork that proves what it is. Read the rule this entry stands on.
Basis under 21 U.S.C. 353a(b)(1)(A)(i)(I): an applicable USP–NF monograph exists for this substance.
Order it through your account.
Reviewed by a person. Approved by a person.