Carbamazepine

Carbamazepine

Название продукта Carbamazepine
Номер CAS 298-46-4
Молекулярная формула C15H12N2O
Молекулярная масса 236.27 g/mol
Внешний вид Кристаллический порошок от белого до небелого цвета
Анализ (ВЭЖХ) 98.0% – 102.0%
Температура плавления 190 – 193 °C
Потери при сушке ≤ 0,51 TP3T
Остаток после прокаливания ≤ 0,11 TP3T
Тяжелые металлы ≤ 20 ppm
Растворимость Slightly soluble in water; soluble in ethanol, acetone, chloroform
Упаковка 25 kg fiber drum with double polyethylene bags

Carbamazepine Structure

Синонимы: 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

Параметр Технические характеристики
Анализ (ВЭЖХ) 98.0% – 102.0%
Потери при сушке ≤ 0,51 TP3T
Тяжелые металлы ≤ 20 ppm
Остаток после прокаливания ≤ 0,11 TP3T
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
  • Срок выполнения заказа: 3–5 рабочих дней (товары, имеющиеся в наличии)
  • Documentation: COA, MSDS, TDS, and regulatory support available upon request.

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Room,5-0203, Unit 5, Beiyuanmen Street,Xi'an,Shaanxi,China

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