Plitidepsin API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Plitidepsin API Manufacturer in India

Plitidepsin is a complex cyclic depsipeptide active pharmaceutical ingredient originally isolated from the Mediterranean tunicate Aplidium albicans. It is identified by CAS Number 137219-37-5, with molecular formula C₅₇H₈₇N₇O₁₅ and molecular weight 1110.3 g/mol. It is also known as Aplidin, Aplidine and Dehydrodidemnin B. (pubchem.ncbi.nlm.nih.gov)

Plitidepsin API

Plitidepsin API is a cyclic depsipeptide with antineoplastic activity. It acts principally through binding to the eukaryotic elongation factor 1A2 (eEF1A2), interfering with protein synthesis and cellular processes associated with tumor-cell survival. (pubchem.ncbi.nlm.nih.gov)

The compound is associated with the development code PM01183 and the pharmaceutical name Aplidin. Its complex peptide-like structure contains multiple stereogenic centers, making stereochemical identity and chromatographic purity important aspects of API characterization.

Chemical and Pharmaceutical Profile

Plitidepsin has the molecular formula C₅₇H₈₇N₇O₁₅ and molecular weight 1110.3 g/mol. PubChem reports an exact mass of 1109.62601509 Da, hydrogen-bond donor count of 4, hydrogen-bond acceptor count of 15, rotatable bond count of 15, and topological polar surface area of 285 Ų. (pubchem.ncbi.nlm.nih.gov)

Key chemical identifiers include:

  • Product Name: Plitidepsin
  • CAS Number: 137219-37-5
  • Molecular Formula: C₅₇H₈₇N₇O₁₅
  • Molecular Weight: 1110.3 g/mol
  • UNII: Y76ID234HW
  • ChEBI: CHEBI:90205
  • DrugBank: DB04977
  • Synonyms: Aplidin, Aplidine, Dehydrodidemnin B
  • Physical Form: Solid
  • Optical Rotation: [α]D −95.9° (c = 1.8, CHCl₃), reported by a chemical reference source

Plitidepsin is a highly complex, stereochemically defined natural-product-derived depsipeptide. (pubchem.ncbi.nlm.nih.gov)

Pharmaceutical Applications

Plitidepsin has been investigated primarily as an antineoplastic agent, particularly in multiple myeloma and other advanced malignancies. It inhibits eEF1A2 and can interfere with protein synthesis and tumor-cell survival. (pubchem.ncbi.nlm.nih.gov)

Its pharmaceutical and research applications include:

  • Oncology drug development
  • Multiple myeloma research
  • Advanced cancer research
  • eEF1A2-targeted research
  • Antitumor mechanism studies
  • Pharmaceutical formulation research
  • API characterization
  • Analytical method development
  • Stability and impurity studies

The European Medicines Agency states that Aplidin was developed for adults with multiple myeloma who had received at least three prior cancer treatments. However, PharmaMar withdrew its EU marketing-authorisation application on 23 July 2025 during re-examination. (ema.europa.eu)

Quality and Analytical Testing

Plitidepsin is a complex peptide-like molecule requiring appropriate chromatographic and spectroscopic characterization. Analytical evaluation can include HPLC, LC-MS/MS, mass spectrometry, NMR, optical rotation and other structural characterization techniques.

Cayman Chemical specifies ≥98% purity for its Plitidepsin reference/research material, while Tocris also reports ≥98% HPLC purity. These values are commercial research-product specifications and should not be represented as a universal pharmacopoeial API acceptance limit. (caymanchem.com)

A separate MedChemExpress research product reports 99.91% purity. This is a product-specific analytical result rather than a universal API specification. (medchemexpress.com)

Plitidepsin API Manufacturer in India

Plitidepsin API is identified by CAS 137219-37-5, molecular formula C₅₇H₈₇N₇O₁₅, and molecular weight 1110.3 g/mol. Its complex cyclic depsipeptide structure requires careful control of identity, stereochemistry, purity and degradation-related impurities. (pubchem.ncbi.nlm.nih.gov)

Quality assessment can include chromatographic purity, structural identification, mass confirmation, stereochemical characterization, residual solvents and other tests defined by the applicable product specification.

Packaging and Storage

Plitidepsin should be packaged in tightly closed, moisture-protective containers suitable for sensitive pharmaceutical or research material.

Commercial research sources recommend protection from moisture and light and controlled-temperature storage. MedChemExpress recommends sealed storage away from moisture and light under nitrogen, with powder storage at −20°C for up to 1 year in its research-product specification. Cayman Chemical reports storage at −20°C. (medchemexpress.com)

For pharmaceutical API material, final storage conditions should be established according to validated stability data, packaging configuration and the applicable batch specification.

Documentation

Applicable documentation may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Safety Data Sheet (SDS)
  • HPLC purity data
  • LC-MS / MS characterization
  • NMR characterization
  • Optical-rotation data
  • Residual-solvent information
  • Stability information
  • Batch analytical results
  • Technical documentation
  • Regulatory documentation, where applicable

Why Choose Plitidepsin API

Plitidepsin is a highly characterized cyclic depsipeptide with significant pharmaceutical research interest in oncology. Its CAS Number 137219-37-5, molecular formula C₅₇H₈₇N₇O₁₅, and molecular weight 1110.3 g/mol provide clear chemical identification. (pubchem.ncbi.nlm.nih.gov)

The availability of analytical reference materials with ≥98% HPLC purity and advanced structural-characterization data supports research and analytical applications. Because plitidepsin is a complex stereochemically defined depsipeptide, appropriate chromatographic and structural characterization is particularly important for API quality assessment. (caymanchem.com)

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) NLT 98.0%
Loss on Drying NMT 0.5%
Residue on Ignition NMT 0.1%
Individual Impurity NMT 0.10%
Water Content NMT 0.5%
Melting Point 152–160°C
Get Bulk Quote via WhatsApp