Temozolomide

Synonyms: Temozolomide, 85622-93-1, Temodar, Temodal, SCH 52365, 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide

Temozolomide is an oral alkylating agent that has become a standard of care in neuro-oncology. It is a synthetic imidazotetrazine derivative that undergoes spontaneous hydrolysis at physiological pH to generate the active metabolite 5-(3-methyltriazen-1-yl)imidazole-4-carboxamide (MTIC), which methylates DNA at the O6 position of guanine, leading to cytotoxicity. Since its approval in the late 1990s, it has been widely used in the treatment of glioblastoma multiforme and anaplastic astrocytoma.

Chemically, temozolomide is a small molecule with a molecular weight of 194.15 g/mol. It is a white to off-white crystalline powder, slightly soluble in water but freely soluble in dimethyl sulfoxide. Its lipophilic nature allows it to cross the blood-brain barrier, a critical property for treating central nervous system tumors. The drug is typically synthesized through a multi-step process starting from 5-aminoimidazole-4-carboxamide, and its purity is critical for both safety and efficacy.

As a generic API, temozolomide is produced under strict cGMP conditions. It is available in various polymorphic forms, with the most stable form being routinely manufactured. The product is standardized to ≥99.0% purity by HPLC, and each batch is tested for residual solvents, heavy metals, and microbial contamination to meet pharmacopeial requirements. It is primarily supplied to generic drug manufacturers and research institutions for the production of oral capsules and for clinical studies.

Function & Mechanism

• DNA alkylation: Methylates guanine residues, causing DNA damage and triggering apoptosis in tumor cells.
• Blood-brain barrier penetration: Lipophilic structure enables effective CNS distribution.
• Prodrug activation: Spontaneously converts to MTIC without enzymatic activation.
• Schedule-dependent activity: Cytotoxic effects are enhanced with prolonged exposure.
• Radiosensitization: Enhances the effects of radiation therapy in glioblastoma treatment.

Source & Standardization

• Source: Synthetic chemical synthesis
• Extraction: Not applicable (synthetic)
• Standardization: ≥99.0% (HPLC)
• Forms: White to off-white crystalline powder
• Applications: Generic drug manufacturing, research studies, oncology formulations

Quality Specifications (QC Tests)

Bulk Supply & Documentation

• Monthly capacity: 500 kg
• Lead time: 3-5 business days (stock items)
• Documentation: COA, MSDS, TDS available upon request
• Packaging: 25 kg fiber drum with double PE bag inside

Frequently Asked Questions

What is the minimum order quantity (MOQ) for Temozolomide?

Our standard MOQ is 1 kg. For research purposes, we can accommodate smaller quantities; please contact our sales team for details.

How long does delivery take?

For stock items, delivery is typically 3-5 business days after order confirmation.

Do you provide a Certificate of Analysis (COA) and samples?

Yes, a COA is provided with every shipment. Samples are available upon request, typically shipped within 1-2 days.

Contact & Ordering Information

• Company: LyvBio Co., Ltd.
• Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
• Email: info@lyvbio.com
• Phone: +86-29-65816888

send us your specification for a quotation.