Mithramycin API Manufacturer in India

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Mithramycin API

Mithramycin, also known as plicamycin, is a naturally occurring antineoplastic antibiotic produced by Streptomyces plicatus. It belongs to the aureolic acid family of antitumor antibiotics and acts primarily by binding to DNA and interfering with transcription.

Mithramycin has the CAS Number 18378-89-7, molecular formula C52H76O24, and molecular weight 1085.15 g/mol. It is a complex polyketide-derived natural product used primarily in oncology and pharmacological research.

Mithramycin API Manufacturer in India

Mithramycin is a specialized oncology and research pharmaceutical compound with applications in studies involving DNA-binding mechanisms, transcriptional regulation and cancer biology.

Important quality attributes include identity, assay, related substances, degradation products, water content, residual solvents, elemental impurities and chromatographic purity.

Chemical Information

CAS Number: 18378-89-7
Molecular Formula: C52H76O24
Molecular Weight: 1085.15 g/mol
Synonyms: Plicamycin, Mithramycin A
Drug Class: Antineoplastic Antibiotic
Therapeutic Area: Oncology
Molecule Type: Natural Product / Polyketide
Chemical Class: Aureolic Acid Glycoside

Mechanism of Action

Mithramycin binds to DNA, particularly GC-rich DNA sequences, in association with divalent metal ions. This interaction can interfere with the binding of transcription factors and suppress transcription of selected genes.

Its biological effects have been investigated in cancer-related pathways, including regulation of gene expression and cellular proliferation.

Pharmaceutical Applications

Mithramycin API is relevant to:

  • Oncology research
  • Antineoplastic drug development
  • DNA-binding research
  • Transcriptional regulation studies
  • Cancer biology research
  • Molecular pharmacology
  • Drug discovery and development
  • Analytical and quality-control research

Historically, plicamycin has been used as an antineoplastic agent, although its clinical use has been limited because of its toxicity profile.

Oncology Applications

Mithramycin has been investigated for its ability to interfere with transcription-dependent cellular processes. Its DNA-binding properties have made it a useful compound in research involving cancer-associated gene expression, transcription factors and tumor-cell proliferation.

Physical Characteristics

Mithramycin is generally described as a yellow to yellow-orange crystalline or amorphous solid. Because it is a complex natural-product molecule, appearance, purity and solid-state characteristics should be controlled according to the applicable API specification.

Manufacturing Process

A controlled Mithramycin production process generally involves biological production and downstream purification:

  1. Selection of qualified production strain
  2. Controlled microbial fermentation
  3. Monitoring of fermentation parameters
  4. Recovery of the active compound
  5. Extraction and purification
  6. Chromatographic purification, where required
  7. Concentration
  8. Crystallization or isolation
  9. Drying under controlled conditions
  10. Final analytical testing
  11. GMP-compliant packaging and storage

Quality Control Testing

Typical Mithramycin API testing may include:

  • Identification by chromatographic methods
  • HPLC assay
  • Related substances
  • Degradation products
  • Chromatographic purity
  • Water content
  • Residual solvents
  • Elemental impurities
  • Specific optical rotation, where applicable
  • Microbiological quality, where applicable
  • Stability testing

Storage

Store Mithramycin API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage requirements should follow validated stability data and the applicable manufacturer's specification.

Pharmaceutical Research

Mithramycin is relevant to research involving:

  • DNA binding
  • GC-rich DNA sequences
  • Transcriptional regulation
  • Transcription-factor inhibition
  • Cancer biology
  • Antineoplastic mechanisms
  • Molecular pharmacology
  • Oncology drug discovery
  • Natural-product drug development

Mithramycin API Summary

Mithramycin, also known as plicamycin or mithramycin A, is a complex aureolic acid antineoplastic antibiotic with CAS Number 18378-89-7, molecular formula C52H76O24, and molecular weight 1085.15 g/mol. It is primarily relevant to oncology, DNA-binding and transcriptional research.

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
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