Plerixafor API Manufacturer in India

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Plerixafor API Manufacturer in India

Plerixafor is a pharmaceutical active ingredient and a CXCR4 chemokine receptor antagonist used as a hematopoietic stem cell mobilizer. It is identified by CAS Number 110078-46-1, with the molecular formula C₂₈H₅₄N₈ and molecular weight 502.80 g/mol. Plerixafor is used in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation. (pubchem.ncbi.nlm.nih.gov)

Plerixafor API

Plerixafor API is a synthetic azamacrocyclic compound consisting of two cyclam rings connected through a 1,4-phenylenebis(methylene) linker. It acts by inhibiting the CXCR4 chemokine receptor and blocking the interaction between CXCR4 and its ligand stromal cell-derived factor-1α (SDF-1α). (dailymed.nlm.nih.gov)

Plerixafor is also known by the development code AMD3100 and is the active ingredient used in plerixafor injection products.

Chemical and Pharmaceutical Profile

Plerixafor has the molecular formula C₂₈H₅₄N₈ and molecular weight 502.80 g/mol. PubChem reports an exact mass of 502.44714376 Da, hydrogen-bond donor count of 6, hydrogen-bond acceptor count of 8, rotatable bond count of 4, and topological polar surface area of 78.7 Ų. (pubchem.ncbi.nlm.nih.gov)

Key chemical identifiers include:

  • Product Name: Plerixafor
  • CAS Number: 110078-46-1
  • Molecular Formula: C₂₈H₅₄N₈
  • Molecular Weight: 502.80 g/mol
  • UNII: S915P5499N
  • ChEBI: CHEBI:125354
  • Development Code: AMD3100
  • Physical Form: White to off-white crystalline solid
  • Melting Point: 131.5°C
  • Physical Character: Hygroscopic

DailyMed identifies Plerixafor as a white to off-white crystalline solid and reports a typical melting point of 131.5°C. (dailymed.nlm.nih.gov)

Pharmaceutical Applications

Plerixafor is a hematopoietic stem cell mobilizer used in combination with filgrastim to mobilize hematopoietic stem cells into peripheral blood for collection and subsequent autologous transplantation.

Its pharmaceutical applications include:

  • Hematopoietic stem-cell mobilization
  • Treatment support in patients with non-Hodgkin's lymphoma
  • Treatment support in patients with multiple myeloma
  • Stem-cell transplantation programs
  • Pharmaceutical formulation development
  • API characterization and analytical testing
  • Stability and quality-control studies

The current U.S. labeling identifies plerixafor injection for use in combination with filgrastim to mobilize hematopoietic stem cells in patients with non-Hodgkin's lymphoma or multiple myeloma. (dailymed.nlm.nih.gov)

Quality and Analytical Testing

Plerixafor has an established USP-NF monograph. USP defines Plerixafor as containing NLT 97.0% and NMT 103.0% of C₂₈H₅₄N₈, calculated on the anhydrous basis. USP also identifies USP Plerixafor Reference Standard and USP Plerixafor System Suitability Mixture as reference materials. (doi.usp.org)

Analytical characterization may include HPLC assay and related-substance testing, spectroscopic identification and other applicable compendial procedures.

Plerixafor is hygroscopic, so water-content control and suitable moisture-protective packaging are important considerations during API handling and storage.

Plerixafor API Manufacturer in India

Plerixafor API is identified by CAS 110078-46-1, molecular formula C₂₈H₅₄N₈, and molecular weight 502.80 g/mol. Its established USP-NF monograph provides a recognized compendial framework for API quality assessment. (doi.usp.org)

Quality evaluation can include identification, assay, related substances, water content and other applicable pharmaceutical quality-control tests according to the approved specification and current pharmacopoeial requirements.

Packaging and Storage

Plerixafor is hygroscopic and should therefore be packaged in tightly closed, moisture-protective pharmaceutical-grade containers.

The USP reference-standard SDS describes Plerixafor as a white/off-white powder and reports it as soluble in water. Commercial API storage should follow the applicable stability data, packaging configuration and approved product specification. (cymitquimica.com)

Documentation

Applicable documentation may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Safety Data Sheet (SDS)
  • USP compliance documentation
  • HPLC assay and purity data
  • Related-substance information
  • Water-content data
  • Analytical characterization data
  • Stability information, where applicable
  • Technical documentation
  • Regulatory documentation, where applicable

Why Choose Plerixafor API

Plerixafor is a well-characterized hematopoietic stem cell mobilizer with an established USP-NF monograph. Its CAS Number 110078-46-1, molecular formula C₂₈H₅₄N₈, and molecular weight 502.80 g/mol provide clear chemical identification. (pubchem.ncbi.nlm.nih.gov)

The USP monograph specifies an assay range of 97.0–103.0% on the anhydrous basis, providing a reliable compendial reference for quality evaluation. Plerixafor's hygroscopic nature also makes appropriate packaging, moisture control and storage important aspects of API quality management. (doi.usp.org

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 97.0–103.0%
Loss on Drying NMT 0.5%
Residue on Ignition NMT 0.2%
Individual Impurity NMT 0.5%
Total Impurities NMT 0.5%
Water Content NMT 0.5%
Melting Point 131.5°C
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