Description

Vinblastine Sulfate USP28 is a high-purity, pharmaceutical-grade alkaloid salt derived from the Madagascar periwinkle plant (Catharanthus roseus). This compound is a critical active pharmaceutical ingredient (API) valued for its potent antimitotic and antitumor properties. It is essential for pharmaceutical manufacturers and research institutions developing and producing injectable chemotherapy formulations, primarily for the treatment of various cancers including Hodgkin's lymphoma, testicular cancer, and breast cancer.

Application

• Oncological Pharmaceutical Manufacturing: Primary use as the active ingredient in sterile injectable solutions for chemotherapy.
• Clinical Research & Development: Used in preclinical and clinical studies for investigating new cancer treatment protocols and combination therapies.
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method validation in pharmaceutical labs.
• Biological Research: A key tool in cell biology and biochemistry research for studying microtubule dynamics, cell cycle arrest, and mechanisms of apoptosis.
• Generic Drug Production: Critical for manufacturers producing generic versions of established vinblastine sulfate injectable drugs.
• Veterinary Oncology: Used in compounding specialized chemotherapeutic treatments for animals.

Basic Information

Product Name	Vinblastine Sulfate USP28
CAS No.	143-67-5
Molecular Formula	C46H58N4O9 · H2SO4
Molecular Weight	909.06 g/mol (for sulfate salt)
Synonyms	Vinblastine Sulfate; Vincaleukoblastine Sulfate; VLB Sulfate; Exal; Velban; Velbe; Vinblastinium Sulfate; 3',4'-Didehydro-4'-deoxy-8'-norvincaleukoblastine Sulfate
EINECS	205-622-9

Quality Control

Our Vinblastine Sulfate USP28 is manufactured and tested to meet the stringent specifications of the United States Pharmacopeia (USP 28) monograph. Every batch undergoes comprehensive analytical testing including identification, assay, impurity profiling, and specific tests for related substances and residual solvents. A Certificate of Analysis (COA) documenting full compliance is provided with each shipment, ensuring traceability and quality assurance for GMP-regulated pharmaceutical production.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as specified on the label. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term stability, storage under inert atmosphere (e.g., nitrogen) is recommended.

Specification

Item	Specification
Appearance	White to slightly yellow, crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	NMT 5.0%
Related Substances (HPLC)	Total impurities NMT 2.0% Any individual impurity NMT 1.0%
Residual Solvents (GC)	Complies with USP <467> and ICH Q3C guidelines
Specific Rotation	-28° to -35° (c = 1 in methanol)
Heavy Metals	NMT 20 ppm
Bacterial Endotoxins	<5.0 EU/mg (where applicable)
Sterility (for sterile grade)	Complies with USP <71>

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