Carbamazepine
| Nazwa produktu | Carbamazepine |
|---|---|
| Numer CAS | 298-46-4 |
| Wzór cząsteczkowy | C15H12N2O |
| Masa cząsteczkowa | 236.27 g/mol |
| Wygląd | Biały lub prawie biały krystaliczny proszek |
| Oznaczenie (HPLC) | 98.0% – 102.0% |
| Temperatura topnienia | 190 – 193 °C |
| Strata przy suszeniu | ≤ 0,5% |
| Popiół po spaleniu | ≤ 0,11 TP3T |
| Metale ciężkie | ≤ 20 ppm |
| Rozpuszczalność | Slightly soluble in water; soluble in ethanol, acetone, chloroform |
| Opakowanie | 25 kg fiber drum with double polyethylene bags |
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Synonimy: 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.
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.
| Parametr | Specyfikacja |
|---|---|
| Oznaczenie (HPLC) | 98.0% – 102.0% |
| Strata przy suszeniu | ≤ 0,5% |
| Metale ciężkie | ≤ 20 ppm |
| Popiół po spaleniu | ≤ 0,11 TP3T |
| Wartości graniczne dla mikroorganizmów | Total aerobic count ≤ 1000 CFU/g; Yeast & mold ≤ 100 CFU/g; E. coli absent |
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