Carbamazepine

Carbamazepine

Product Name Carbamazepine
CAS Number 298-46-4
Molecular Formula C15H12N2O
Molecular Weight 236.27 g/mol
Appearance White to off-white crystalline powder
Assay (HPLC) 98.0% – 102.0%
Melting Point 190 – 193 °C
Loss on Drying ≤ 0.5%
Residue on Ignition ≤ 0.1%
Heavy Metals ≤ 20 ppm
Solubility Slightly soluble in water; soluble in ethanol, acetone, chloroform
Package 25 kg fiber drum with double polyethylene bags

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Carbamazepine Structure

Synonyms: 5H-Dibenz[b,f]azepine-5-carboxamide, 5-Carbamoyl-5H-dibenz[b,f]azepine, Carbamazepinum, CBZ, Biston, Finlepsin, Tegretol

Carbamazepine remains a cornerstone in the treatment of epilepsy and bipolar disorder, with steady demand from pharmaceutical manufacturers worldwide. Its established efficacy and favorable cost profile keep it a preferred API for generic formulations, especially in emerging markets where access to affordable anticonvulsants is critical.

This dibenzazepine carboxamide derivative is synthesized through a multi-step process from iminodibenzyl, yielding a white to off-white crystalline powder. It is practically insoluble in water but dissolves readily in organic solvents such as ethanol and acetone, a property that influences formulation strategies for both immediate and extended-release dosage forms.

LyvBio supplies Carbamazepine that meets or exceeds pharmacopeial standards, including USP, EP, and BP. With assay typically between 98.0% and 102.0% on a dried basis, our material ensures consistent potency for tablet and suspension manufacturing. Each batch is thoroughly tested for impurities, residual solvents, and heavy metals to support regulatory submissions.

Product Overview & Composition

Carbamazepine is a synthetic dibenzazepine derivative with the molecular formula C15H12N2O and a molecular weight of 236.27 g/mol. It is structurally related to tricyclic antidepressants but functions primarily as a sodium channel blocker, reducing neuronal hyperexcitability.

The API is available in various polymorphic forms, with the triclinic form being the most stable and commonly used in solid dosage forms. Our production process is tightly controlled to consistently deliver the desired polymorph, ensuring predictable dissolution and bioavailability.

Key Applications

  • Epilepsy treatment: Indicated for partial seizures, generalized tonic-clonic seizures, and mixed seizure patterns.
  • Bipolar disorder: Used as a mood stabilizer to prevent manic and depressive episodes.
  • Trigeminal neuralgia: First-line therapy for the sharp, shooting pain associated with this condition.
  • Off-label uses: Sometimes prescribed for neuropathic pain, alcohol withdrawal, and certain psychiatric disorders.
  • Research: Employed in studies investigating sodium channel function and anticonvulsant mechanisms.

Quality & Standards

Parameter Specification
Assay (HPLC) 98.0% – 102.0%
Loss on Drying ≤ 0.5%
Heavy Metals ≤ 20 ppm
Residue on Ignition ≤ 0.1%
Microbial Limits Total aerobic count ≤ 1000 CFU/g; Yeast & mold ≤ 100 CFU/g; E. coli absent

Packaging & Supply

  • Packaging: 25 kg fiber drums with double polyethylene liners, or as per customer request.
  • MOQ: 25 kg
  • Lead time: 3-5 business days (stock items)
  • Documentation: COA, MSDS, TDS, and regulatory support available upon request.

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