Active Pharmaceutical Ingredient

Mitotane

Also known as: Lysodren; o,p'-DDD

CAS: 53-19-0 Adrenocortical Cytotoxic Agent IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Mitotane API — Mediocon Inc
Mitotane — Pharmaceutical Grade API

Product Overview

CAS No: 53-19-0  |  MF: C₁₄H₁₀Cl₄  |  MW: 320.04 g/mol

Mirtazapine is a pharmaceutical-grade active ingredient classified as Adrenocortical Cytotoxic Agent. Mediocon Inc supplies high-purity Mitotane conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Key Features

  • Adrenocorticostatic agent
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Adrenocortical carcinoma treatment
  • Cushing's syndrome (ectopic ACTH)
  • Unresectable adrenal tumors

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameMitotane
Also Known AsLysodren; o,p'-DDD
CAS Number53-19-0
Chemical Name1-chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl]benzene
Molecular FormulaC₁₄H₁₀Cl₄
Molecular Weight320.04 g/mol
CategoryNaSSA Antidepressant
AppearanceWhite crystalline powder
SolubilityPractically insoluble in water; soluble in organic solvents
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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