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Temozolomide API

Name of Product Temozolomide
CAS No 85622‑93‑1
Therapeutic use:- Alkylating prodrug – brain tumors (glioblastoma, astrocytoma)
Grade IP/USP/EP/BP
Form:- API Powder
Status Commercial
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Product Overview

Temozolomide API is a popular anti-cancer active pharmaceutical ingredient (API).

It is an alkylating agent type of drug. They are temozolomide APIs that become attached to the DNA of the cancerous cells.

This also makes it impossible for the cells to grow. Hence, the tumour growth is reduced or inhibited.

It is absorbed very easily and can penetrate through the blood–brain barrier.

This makes it extremely useful in the treatment of brain tumours, where other drugs cannot be administered.

Therapeutic Applications

Temozolomide API works well because it can reach the brain.

This makes it a strong used in formulation of oncology drugs to treat tough brain cancers.

  • Glioblastoma multiforme (GBM): It’s often the first co-administered formulations in cancer therapy. After that, for development of injectable or oral dosage forms to help stop the cancer from coming back.

  • Anaplastic astrocytoma: Used when the tumor grows again or doesn’t improve with other medicines.

  • Other cancers (under study): Researchers are testing it for melanoma, sarcoma, and other hard-to-treat cancers.

Specification Parameters

  • CAS number: 85622-93-1

  • Molecular Formula: C6H6N6O2

  • Molecular Weight: 194.15 g/mol

  • Purity (HPLC): ≥ 99%

  • Melting Point: ~212–214°C (decomposes)

  • Identification Tests: IR spectrum and HPLC retention time match with reference

  • Heavy Metals: Less than 10 ppm, within pharmacopeia limits

  • Microbiological Tests: Meets pharmacopeial standards

  • Residual Solvents are below ICH Q3C limits

  • Appearance of this api is white to pale yellow crystalline powder

  • Solubility turns out to be weakly soluble in water, soluble in ethanol, and DMSO.

Packaging & Storage

Temozolomide API is packed to prevent moisture and light damage. 

It is manufactured under stringent quality systems and is evaluated for purity, stability, and safety.

Double polyethylene liners in HDPE bottles or fiber drums for packing.

Pack sizes include 1 g, 10 g, 100 g, 1 kg, and bulk 25 kg drums.

Product name, CAS number, batch code, manufacture date, expiry date, and storage conditions on every container.

Keep sealed in a dry, cold place at 2–8°C. Protect from heat, light, and air.

2–3 years if stored under recommended conditions.

Tamper-evident closures assure safety in handling and shipping.

Why Choose Us

Produced under WHO-GMP and ISO-certified facilities. Each batch is assayed several times during the process by Actiza Pharmaceutical Pvt Ltd.

Drug Master Files (DMF) and Common Technical Documents (CTD) are available for filings worldwide.

Available in research-grade packaging or large commercial batches.

Supplied to leading oncology companies in the US, Europe, Asia, and Latin America.

Technical and regulatory teams help with end-to-end support on applications, compliance, and testing.