Methylcobalamin is a coenzyme form of vitamin B12 used as an active pharmaceutical ingredient (API) in oral tablets, capsules and oral solutions. It provides a pharmaceutically pure methylated cobalamin for one-carbon transfer reactions in humans.
⚠️ This product is for pharmaceutical compounding and manufacturing only. Not for direct consumer use. Customer is required to submit relevant documents before purchase.
Methylcobalamin functions as a cofactor for methionine synthase in the remethylation of homocysteine to methionine and is involved in cobalamin-dependent pathways that support myelin integrity and hematopoiesis. It is widely used in formulations intended for vitamin B12 deficiency and neurological support (for example peripheral neuropathy), with indications and dosing defined by local regulations and product labeling.
The API is supplied as a crystalline powder manufactured under controlled conditions with HPLC assay typically 99-100% on a dried basis. The material is sensitive to light and prolonged elevated temperature; storage and processing should minimise exposure to light, heat, moisture and oxidation and use suitably protective primary packaging.
Pharmaceutical Grade: Active pharmaceutical ingredient (API) methylcobalamin, typical assay 99-100% (HPLC, dried basis)
CAS Number: 13422-55-4
Molecular Formula: C63H91CoN13O14P
Molecular Weight: 1344.4 g/mol
Specifications (COA/Pharmacopeial):
Appearance: Red to very dark red crystals or powder
Identification: Conforms to structure (for example infrared spectrum, X-ray diffraction)
Assay (HPLC, dried basis): 99-100%
Water (Karl Fischer): 0-11%
Related substances: Complies with internal specification / current COA
Residual solvents and heavy metals: Controlled within applicable guideline limits
Microbial limits: Controlled according to internal specification suitable for oral solid dosage forms
Pharmaceutical Applications:
- API for oral tablets and capsules containing methylcobalamin as vitamin B12
- Combination products with other B-complex vitamins, folate or metabolic co-factors
- Orally disintegrating tablets, lozenges or sublingual forms where rapid oral release is desired
- Oral solutions or drops formulated to deliver defined microgram doses per mL
Typical Usage Levels (formulation design):
- Tablets/capsules: formulated to deliver approximately 500-1500 micrograms methylcobalamin per unit dose (or as required by the target product profile and local regulations)
- Orally disintegrating tablets/lozenges: similar unit doses to tablets, adjusted for disintegration time and excipient load
- Oral solutions/drops: formulated to deliver an equivalent daily dose per measured volume (for example per mL or per 5 mL), according to approved labeling
GMP and Regulatory Information:
- Manufactured in a GMP-compliant facility with batch-wise Certificate of Analysis (COA)
- Supplied with Safety Data Sheet (SDS) and supporting quality documentation on request
- Suitable for use in regulated pharmaceutical products where methylcobalamin APIs are permitted; final product registration, indications and labeling remain the responsibility of the finished product manufacturer
Stability and Storage:
Shelf life: typically 36 months from manufacture when stored in the original, tightly closed container under recommended conditions
Storage: store refrigerated (2-8 °C), protected from light and moisture; avoid repeated freeze-thaw and prolonged exposure to high temperature
Packaging and Documentation: Supplied in sealed containers suitable for cold-chain shipment; COA and SDS available for each batch.
Regulatory Note: This material is intended for use by licensed pharmaceutical manufacturers, hospitals and compounding pharmacies only. Product design, patient selection, dosing and labeling must follow applicable regulations, guidelines and professional judgment.
