Description

Carmustine is a highly potent alkylating nitrosourea compound with significant antitumor activity. This active pharmaceutical ingredient (API) is critical for the formulation of chemotherapeutic agents used in targeted cancer treatment regimens. It is primarily required by pharmaceutical manufacturers and advanced research institutions specializing in oncology drug development and clinical applications.

Application

• Oncological Pharmaceutical Manufacturing: As a key active pharmaceutical ingredient (API) in the synthesis of injectable chemotherapeutic drugs.
• Brain Tumor Therapy: Formulation into medications for the treatment of glioblastoma multiforme, brainstem glioma, medulloblastoma, and astrocytoma.
• Hematologic Malignancies: Used in the treatment of Hodgkin's and non-Hodgkin's lymphoma, as well as multiple myeloma.
• Bone Marrow Transplantation: Employed in high-dose conditioning regimens prior to transplant procedures.
• Topical Formulations: Development of localized treatments, such as wafer implants (Gliadel®), for sustained release at tumor sites.
• Clinical Research: Serving as a reference standard and investigational agent in preclinical and clinical oncology studies.
• Combination Chemotherapy: A component in multi-drug protocols to enhance therapeutic efficacy against resistant cancers.

Basic Information

Product Name	Carmustine
CAS No.	154-93-8
Molecular Formula	C5H9Cl2N3O2
Molecular Weight	214.05 g/mol
Synonyms	BCNU; 1,3-Bis(2-chloroethyl)-1-nitrosourea; Nitrumon; BiCNU; Gliadel; Carmubris; SK 27702; NSC-409962; N,N'-Bis(2-chloroethyl)-N-nitrosourea
EINECS	205-838-2

Quality Control

Our Carmustine is manufactured under strict quality management systems. Each batch is subjected to rigorous analytical testing to ensure it meets high-purity pharmacopeial standards, including identity, potency, and impurity profile. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing results for assay, related substances, residual solvents, and other critical parameters. We support compliance with cGMP (current Good Manufacturing Practice) guidelines for API production.

Storage

Preserve in a tightly closed container, protected from light. Store in a freezer at -20°C to -10°C under an inert atmosphere (e.g., nitrogen or argon) to prevent oxidation and degradation. Allow the sealed container to equilibrate to room temperature before opening to avoid condensation. The storage area must be dry, well-ventilated, and designated for hazardous materials.

Specification

Item	Specification
Appearance	White to pale yellow crystalline powder or solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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