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Trilostane

CAS: 13647-35-3
Molecular Formula: C20H27NO3
MOQ: 1 kg

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Introduction
GMP Certified In Stock API Grade

Trilostane

4a,5-Epoxy-17b-hydroxy-3-oxoandrostane-2a-carbonitrile

High-purity Trilostane active pharmaceutical ingredient manufactured under strict GMP conditions. Supplied as a white to off-white crystalline powder with comprehensive analytical documentation including Certificate of Analysis (COA)and regulatory compliance packages. Reliable supply chain for global veterinary pharmaceutical manufacturers.

CAS Number
13647-35-3
Molecular Formula
C20H27NO3
Molecular Weight
329.43 g/mol
Therapeutic Category
Cushing's syndrome

Certificate of Analysis

PASS
COA No.
FP260309-101
Batch
9040B2603001
Mfg Date
Oct 01, 2025
Retest Date
Sep 30, 2028
Spec Ref
QS-9040B-1

Key Analytical Results

Appearance
Off-white powder
Specific Rotation
+135 to +142 deg
+138 deg
Loss on Drying
NMT 0.5%
0.26%
Assay (HPLC)
98.0 - 102.0%
99.5%
Total Impurities
NMT 1.0%
0.27%
Residual Methanol
NMT 3000 ppm
796 ppm
Meets the above specification

01 / Overview

Product Overview

A synthetic steroid analogue manufactured under GMP conditions with full traceability.

N

Chemical Identity

Trilostane is a synthetic steroid analogue that acts as a competitive inhibitor of 3b-hydroxysteroid dehydrogenase, an enzyme critical in the biosynthesis of cortisol and aldosterone. It belongs to the class of steroidogenesis inhibitors and features a distinctive epoxide and nitrile functional group.

M

Mechanism of Action

Trilostane reversibly inhibits 3b-hydroxysteroid dehydrogenase (delta4-isomerase), blocking the conversion of pregnenolone to progesterone and subsequently reducing the synthesis of cortisol, aldosterone, and other corticosteroids in the adrenal cortex.

Q

Quality Assurance

Each batch undergoes comprehensive analytical testing including HPLC assay, IR identification, related substances profiling, residual solvent analysis by GC, and granulometry. Full batch traceability guaranteed.


02 / Specifications

Specifications and Analytical Data

Full analytical results for batch 9040B2603001 against specification QS-9040B-1.

Test Parameter Method Specification Result
AppearancePhysical description
Visual White to off-white powder Off-white powder
IdentificationIR Spectroscopy
IR IR spectrum of sample complies with Reference Standard Conforms
IdentificationHPLC Retention Time
HPLC RT of the major peak complies with Reference Standard Conforms
Specific RotationOptical activity
Polarimetry +135 to +142 deg (on dried basis) +138 deg
Loss on DryingMoisture content
Gravimetric NMT 0.5% 0.26%
Residue on IgnitionInorganic residue
Ignition NMT 0.1% 0.07%
Maximum Single ImpurityUnknown related substance
HPLC (%Area) NMT 0.20% 0.13%
Total ImpuritiesSum of all related substances
HPLC (%Area) NMT 1.0% 0.27%
AssayPotency
HPLC (%w/w) 98.0% - 102.0% (on dried basis) 99.5%
Residual SolventsMethanol
GC (%w/w) NMT 3000 ppm 796 ppm
GranularityParticle size distribution
Laser Diffraction D[90] NMT 20 um 11.033 um

03 / Applications

Applications and Indications

Trilostane API is primarily used in veterinary pharmaceutical formulations.

V

Veterinary Medicine

Trilostane is the active pharmaceutical ingredient in veterinary formulations used for the treatment of hyperadrenocorticism (Cushing's syndrome) in dogs. It is marketed under brand names such as Vetoryl and is the most widely prescribed medical treatment for canine Cushing's disease globally.

E

Endocrine Research

Utilized as a pharmacological tool in research settings studying adrenal steroidogenesis pathways, aldosterone biosynthesis disorders, and the development of novel steroidogenesis inhibitors. Also used in studies investigating Conn's syndrome and primary hyperaldosteronism.

F

Formulation Development

Our fine-milled Trilostane powder (D[90] = 11 um) with controlled particle size distribution is optimized for capsule and oral dosage form manufacturing. The small particle size ensures consistent content uniformity and improved dissolution in finished formulations.


04 / Logistics

Packaging and Storage

5kg

HDPE Double-Lined Drum

Standard packaging unit - Custom quantities available

Packaging Details

  • Container Type5 kg / HDPE Drum
  • Inner LinerDouble polyethylene bag
  • Containers per Unit1 drum
  • Net Weight5 kg
  • Storage ConditionsBelow 25 C, protect from light and moisture
  • Shelf Life3 years from manufacture
  • Retest Period36 months (Retest: Sep 30, 2028)
  • ShippingRoom temperature, non-hazardousRelated Products
 
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