TCS Industries Limited (China-sourced API supplier) supplies Mitotane — API CAS 53-19-0 for pharmaceutical B2B procurement — COA, MSDS, and technical documentation available on request.
> Overview
| Product Name | Mitotane |
|---|---|
| Structural Formula |  |
| CAS Number | 53-19-0 |
| Molecular Formula | C14H10Cl4 |
| Molecular Weight | 320.0 g/mol |
| InChIKey | JWBOIMRXGHLCPP-UHFFFAOYSA-N |
| SMILES | Available on request where applicable |
| Appearance | White to off-white crystalline powder |
| Purity / Grade | By agreed specification and batch COA |
| Storage | Store at controlled room temperature, protect from light |
Mitotane (CAS 53-19-0, also known as o,p’-DDD) is an adrenolytic agent with the formula C₁₄H₁₀Cl₄ (MW 320.04). It is a dichlorodiphenyldichloroethane isomer that selectively destroys adrenocortical cells. Mitotane is the only approved drug for adrenocortical carcinoma (ACC) and is also used for Cushing syndrome. It is on the WHO Model List of Essential Medicines.
TCS Industries Limited, a Hong Kong-based trading and sourcing company, supplies Mitotane API in pharmaceutical grade for global procurement programs.
> Applications
Adrenocortical carcinoma treatment
Mitotane is administered orally at 2–6 g/day in divided doses for adrenocortical carcinoma, with target plasma levels of 14–20 mg/L. It causes selective necrosis of zona fasciculata and zona reticularis cells through mitochondrial toxicity. Adjuvant mitotane after surgical resection reduces recurrence risk. Terzolo et al. (N Engl J Med, 2007, 356:2372–2380) demonstrated that adjuvant mitotane significantly prolonged recurrence-free survival in patients with adrenocortical carcinoma after radical resection.
Cushing syndrome management
Mitotane at lower doses (0.5–3 g/day) is used off-label for Cushing syndrome (ACTH-dependent or independent) to reduce cortisol production. Its adrenolytic action reduces functional adrenal cortex mass. Patients require glucocorticoid and mineralocorticoid replacement therapy during treatment.
> Sourcing & Supply
TCS Industries Limited supports development, qualification and commercial purchasing discussions for Mitotane with buyers in Australia, New Zealand, Canada and South Korea.
- Evaluation and commercial quantities: 100 g samples for analytical qualification; 1 kg for formulation development; 5–25 kg drums for production. Pharmaceutical-grade crystalline powder. DMF documentation available.
- Pallet quantities and production campaigns: repeat supply is coordinated against packaging, lead time, annual demand and destination-market import requirements.
> Quality & Documentation
Key specification parameters include assay (≥98.0% by HPLC), related substances (o,p’-DDE, o,p’-DDA, p,p’-DDD isomer), loss on drying, residue on ignition, heavy metals, residual solvents, and particle size distribution. White to off-white crystalline powder. Practically insoluble in water, soluble in dichloromethane and ethanol. Melting point 76–78 °C. Identity by HPLC and IR. Meets in-house pharmaceutical specifications. COA and MSDS are standard.
> Packaging
Mitotane is a white to off-white crystalline powder with low water solubility. Standard packaging includes double PE-lined aluminium foil bags in fibre drums (1 kg or 5 kg). Store at controlled room temperature (15–25 °C). Protect from light. Shelf life is typically 24–36 months. Labels and documents are checked before dispatch.
> Pricing & MOQ
Pricing is quoted by specification, packaging and destination. Common commercial discussions use 25 kg bag/drum formats, pallet quantities and production-campaign planning; smaller samples may be reviewed for qualified formulation teams.
> Regulatory & Compounding Context
Mitotane is FDA-approved (Lysodren, 1970) for adrenocortical carcinoma. EMA-authorized as an orphan medicinal product. On the WHO Model List of Essential Medicines. Limited generic competition due to orphan status and narrow market. Manufacturing requires API process validation and stability data. DMF support available.
> Alias Index
- INN: Mitotane
- CAS Number: 53-19-0
- Formula: C₁₄H₁₀Cl₄ (MW 320.04)
- Chemical name: 1,1-(2-Chlorophenyl)(4-chlorophenyl)-2,2-dichloroethane (o,p’-DDD)
- Brand name: Lysodren (HRA Pharma)
- ATC code: L01XX23
- Commercial request terms: mitotane API, Lysodren generic, o,p-DDD pharmaceutical grade, adrenocortical carcinoma drug, TCS Industries Limited
> FAQ
What plasma level is required for efficacy?
Target plasma mitotane concentration is 14–20 mg/L for adrenocortical carcinoma. Below 14 mg/L, response rates are significantly lower. Above 20 mg/L, neurological toxicity risk increases. Therapeutic drug monitoring (TDM) by HPLC or GC-MS is required. Achieving target levels typically takes 3–5 months due to slow accumulation in adipose tissue.
What documents are available for Mitotane orders?
COA and MSDS are standard for commercial discussions. COO, packing list, invoice and other import-support documents can be arranged according to order scope.
Do you supply Mitotane to Australia and Canada?
Yes. We support B2B buyers in Australia, New Zealand, Canada and South Korea, subject to route and document review.
Do you supply New Zealand and South Korea?
Yes. We review Australia, New Zealand, Canada and South Korea for project supply, import documents, packaging and logistics planning before quotation.
Why is Mitotane difficult to formulate?
Mitotane is practically insoluble in water (0.1 mg/mL), making dissolution the rate-limiting step for absorption. Oral bioavailability is ~40% and is highly variable. Current tablet formulations (500 mg) are taken with fatty food to enhance absorption. Micronized formulations and lipid-based drug delivery systems are under investigation to improve bioavailability.
Is Mitotane an orphan drug?
Yes. Mitotane has orphan drug designation in both the US and EU for adrenocortical carcinoma. Adrenocortical carcinoma incidence is approximately 1–2 per million per year. Orphan status provides market exclusivity and regulatory incentives but limits generic competition.
Can you arrange samples before commercial purchasing?
Samples or evaluation quantities may be reviewed for qualified buyers after target specification, application and destination-market requirements are clarified.
How is Mitotane packaged for export?
Packaging is confirmed by quantity and material properties. Typical options include foil bags, HDPE containers, fibre drums, 25 kg bags or palletized export packaging.
Can buyer-defined specifications be reviewed?
Yes. Send the specification, methods, impurity limits and required documents. TCS can review feasibility before confirming quotation and lead time.
What payment terms are normally used?
Standard payment is 100% T/T before dispatch unless a different arrangement has been approved for an established commercial account.
What lead time should buyers expect?
Lead time depends on stock, batch size, document scope and destination. Available stock can move faster; made-to-order or pallet programs require longer planning.
What replacement therapy is needed during treatment?
Mitotane destroys functional adrenal cortex, requiring glucocorticoid replacement (hydrocortisone 20–30 mg/day in divided doses). Mitotane also induces CYP3A4, increasing cortisol metabolism — glucocorticoid doses must be approximately doubled. Mineralocorticoid replacement (fludrocortisone) is needed if aldosterone production is affected.
Last reviewed: June 2026
Evaluation and research orders (≤10 kg) are shipped with COA, MSDS, and certificate of origin. Bulk commercial orders (>10 kg) qualify for volume pricing with a full technical documentation package available on request.
> Request a Quote
If your team already has a target application, estimated quantity, destination market, or documentation requirements, send those details so the commercial response can be prepared more efficiently.