Vinblastine is a naturally derived antineoplastic alkaloid belonging to the vinca alkaloid class of pharmaceutical compounds. In pharmaceutical applications, Vinblastine is commonly supplied and used in its sulfate salt form, Vinblastine Sulfate. It is an important cytotoxic active pharmaceutical ingredient used in oncology formulations and is associated with the treatment of several malignant diseases.
Vinblastine is structurally related to other vinca alkaloids and acts primarily by interfering with microtubule formation. Its mechanism involves binding to tubulin, which inhibits the assembly of microtubules required for normal mitotic spindle formation. This interference with cell division results in inhibition of rapidly proliferating cancer cells.
Vinblastine Sulfate has the chemical formula C46H58N4O9·H2SO4 and a molecular weight of approximately 909.06 g/mol. Its CAS Number is 143-67-9. The active moiety, Vinblastine, has the molecular formula C46H58N4O9 and a molecular weight of approximately 811.0 g/mol. The sulfate salt is the pharmaceutical form represented in the USP monograph.
Vinblastine Sulfate is described as a white to slightly yellow crystalline powder. The material is a complex alkaloid with multiple stereochemical centers and is generally handled under controlled pharmaceutical manufacturing conditions.
Vinblastine belongs to the vinca alkaloid group of antimitotic agents. Its pharmacological activity is associated with interaction with tubulin, a structural protein required for microtubule formation.
During cell division, microtubules form an essential component of the mitotic spindle. Vinblastine interferes with microtubule assembly, disrupting spindle formation and preventing normal progression through mitosis. This mechanism contributes to its cytotoxic activity against susceptible rapidly dividing cells.
Because of this mechanism, Vinblastine is an important oncology API for pharmaceutical formulations intended for antineoplastic treatment.
Vinblastine API is relevant to pharmaceutical manufacturers, oncology product developers and organizations involved in the production of finished pharmaceutical formulations. As a Vinblastine API manufacturer and supplier in India, the material can be positioned for pharmaceutical development and manufacturing applications requiring controlled-quality oncology APIs.
Quality control of Vinblastine Sulfate is particularly important because the substance is a potent cytotoxic pharmaceutical ingredient. Manufacturing and handling processes should therefore be performed using suitable containment, analytical controls and applicable pharmaceutical quality systems.
Vinblastine Sulfate is used as an antineoplastic pharmaceutical ingredient. Its clinical applications have included various hematological malignancies and solid tumors. The specific indications and combination regimens depend on the approved pharmaceutical product and applicable regulatory requirements.
Vinblastine has historically been used in oncology treatment protocols involving diseases such as Hodgkin lymphoma, non-Hodgkin lymphoma, testicular cancer, breast cancer and other malignancies. Its use may occur alone or in combination with other anticancer agents depending on the therapeutic protocol.
For pharmaceutical manufacturing purposes, Vinblastine Sulfate is therefore categorized as an antineoplastic API, vinca alkaloid API, and oncology pharmaceutical ingredient.
Vinblastine Sulfate has a molecular weight of approximately 909.1 g/mol. PubChem reports a melting-point range of 543–545°F, equivalent to approximately 284–285°C, while other references for the parent Vinblastine report different thermal values. Because thermal behavior can vary with salt form, hydration state and measurement conditions, the specific value should be treated as a reference physical property rather than an automatic release specification.
PubChem reports Vinblastine Sulfate solubility of ≥10 mg/mL at approximately 24.5°C from the cited NTP data. Other references describe Vinblastine itself as having low or negligible water solubility while the sulfate form is substantially more water soluble. Therefore, the sulfate salt should be clearly identified when presenting solubility information.
The USP-NF monograph for Vinblastine Sulfate defines the substance as containing not less than 96.0% and not more than 102.0% of Vinblastine Sulfate, with corrections applied for loss in weight. This provides a recognized compendial assay range for the API.
Analytical quality control for Vinblastine Sulfate can include identity testing, assay, chromatographic purity, related substances, water or moisture determination and other applicable quality attributes. The exact release specification should correspond to the applicable pharmacopoeial monograph, regulatory requirements and validated manufacturing specification.
For CMS presentation, specifications should not be represented as universal values when a parameter is method-dependent or product-specific. Where a reliable compendial numerical limit is available, it can be presented directly; otherwise, the field should be identified as product-specific or not applicable.
Vinblastine Sulfate is a specialized oncology API requiring controlled pharmaceutical manufacturing and analytical handling. Its complex alkaloid structure makes appropriate analytical characterization important for maintaining identity, purity and potency.
Manufacturers and pharmaceutical developers working with Vinblastine Sulfate may evaluate the material using chromatographic techniques and other validated analytical procedures suitable for alkaloid APIs. Control of related substances and degradation products is particularly important for maintaining consistent pharmaceutical quality.
Vinblastine Sulfate should be stored and handled according to the applicable API specification, safety documentation, stability data and regulatory requirements. Because Vinblastine is a cytotoxic antineoplastic substance, appropriate occupational safety procedures and containment controls should be implemented during pharmaceutical manufacturing and handling.
Packaging should protect the material from conditions that could adversely affect its chemical quality. Specific storage requirements should be established from the applicable validated stability program and product documentation rather than applying an unsupported universal storage condition.
Vinblastine, principally used in pharmaceutical manufacturing as Vinblastine Sulfate, is an important vinca alkaloid and antineoplastic API. Its mechanism is associated with disruption of microtubule formation and inhibition of mitotic cell division.
Vinblastine Sulfate has the molecular formula C46H58N4O9·H2SO4, molecular weight of approximately 909.06 g/mol, and CAS Number 143-67-9. The USP monograph specifies an assay range of 96.0–102.0% for Vinblastine Sulfate.
With its established role in oncology pharmaceutical development, Vinblastine Sulfate can be categorized as a Vinblastine API, Vinblastine Sulfate API, antineoplastic API, oncology API and vinca alkaloid pharmaceutical ingredient.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 96.0–102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Water Content | NMT 0.5% |
| Melting Point | Approx. 284–285°C |
| Solubility | ≥10 mg/mL at approximately 24.5°C (reported reference value for Vinblastine Sulfate) |