Description

Primidone CAS NO 125-33-7 is a synthetic anticonvulsant drug belonging to the barbiturate class, chemically known as 5-ethyldihydro-5-phenyl-4,6(1H,5H)-pyrimidinedione. It is a critical active pharmaceutical ingredient (API) valued for its efficacy in controlling and preventing epileptic seizures. This compound is essential for pharmaceutical manufacturers and research institutions developing treatments for epilepsy and essential tremor.

Application

• Primary Pharmaceutical Ingredient: Core active component in the formulation of oral anticonvulsant/antiepileptic medications.
• Epilepsy Treatment: Used in the management of complex partial (psychomotor) seizures and generalized tonic-clonic (grand mal) seizures.
• Essential Tremor Management: Employed in therapeutic regimens for controlling benign essential tremor.
• Pharmaceutical Research & Development: Serves as a key reference standard and intermediate in neurological drug discovery and analytical method development.
• Generic Drug Manufacturing: A fundamental API for producers of generic anticonvulsant drugs, ensuring cost-effective treatment options.
• Clinical Trial Material: Supplied as a high-purity compound for use in clinical studies and bioequivalence testing.

Basic Information

Product Name	Primidone
CAS No.	125-33-7
Molecular Formula	C12H14N2O2
Molecular Weight	218.25 g/mol
Synonyms	5-Ethyldihydro-5-phenyl-4,6(1H,5H)-pyrimidinedione; 5-Ethyl-5-phenyl-hexahydropyrimidine-4,6-dione; Desoxyphenobarbital; 2-Desoxyphenobarbital; Primaclone; Liskantin; Mizodin; Mysoline; Sertan; Hexamidine; Prysoline; Apo-Primidone
EINECS	204-737-6

Quality Control

Our Primidone is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Every batch undergoes comprehensive analytical testing including identification, assay, and impurity profiling to ensure high purity and batch-to-batch consistency. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming specifications for identity, potency, related substances, residual solvents, and heavy metals.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Keep away from heat, open flames, and incompatible materials. The container must be kept tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Conforms to standard
Assay (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Loss on Drying	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C
Microbiological Enumeration	Complies with EP/USP

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.