Description

Technical Parameters

Core Introduction to Testosterone enanthate Raw Material Powder

Pharmaceutical -grade raw material | Testosterone enanthate (long-acting testosterone ester raw material ) made in China

Chemical name : 17β-hydroxy-androst-4-ene-3-ketoheptanoate

CAS No .: 315-37-7

Molecular formula : C₂₆H₄₀O₃

Molecular weight : 400.60

EINECS ID : 206-264-7

Melting point : 34-36℃

Appearance : White or off-white crystalline powder

Purity : ≥99% (HPLC detection)

Solubility : Easily soluble in ethanol and acetone, slightly soluble in vegetable oils.

Core Properties

Testosterone enanthate is a long-acting testosterone ester compound that is widely used in the production of long-acting testosterone preparations, as a raw material for hormone replacement therapy, and in sports medicine applications due to its excellent stability and sustained-release properties .

✅ Advantages of esterification structure :

Long-lasting release : The heptanate ester side chain provides a stable release period of 7-10 days.

High stability : Esterification enhances chemical stability and extends shelf life.

High oil solubility : Good lipid solubility, suitable for preparing oil-based injections.

✅ The quality advantages of "Made in China" :

Purity Guaranteed : Distillation and crystallization process, purity ≥99%, single impurities ≤0.1%

Crystal form control : Stable β-crystal form ensures reproducibility of formulation processes.

Heavy metal control : Lead, arsenic and other heavy metal content <10ppm

✅ Global supply assurance :

Multiple packaging options : Available in 1kg/bag, 5kg/drum, and other sizes.

Cold chain transportation : constant temperature transportation at 15-25℃ to ensure the stability of raw materials.

Customs clearance support : Complete export documents such as MSDS and COA.

Production process and quality assurance

1. Advantages of the synthesis process :

Esterification reaction : Esterification using the acyl chloride method, with a reaction efficiency >98%.

Purification process : Three-stage crystallization purification to obtain high-purity crystals.

Drying technology : Vacuum low-temperature drying, moisture content ≤0.5%

2. Strict quality control standards :

Chemical purity :

Main component content: 99.0%~101.0%

Related substances: Single impurity ≤0.1%, total impurities ≤0.5%

Residual solvent: Complies with ICH Q3C standards

Physical properties :

Particle size distribution: D50 50-100μm

Bulk density: 0.4-0.6 g/cm³

Solubility: Meets the standards for active pharmaceutical ingredients.

3. Stability data :

Long-term stability : Stable for 36 months at 25℃/60%RH.

Accelerated testing : Passed after 6 months at 40℃/75%RH.

Transportation stability : Vibration and drop tests passed.

Application areas and formulation advantages

1. Pharmaceutical Applications :

Injectable oil preparations : used to prepare injections with a concentration of 100-250 mg/ml.

Sustained-release properties : Provides stable blood drug concentrations, reducing injection frequency.

Excellent compatibility : Compatible with a variety of injectable oils.

2. Medical Applications :

Testosterone replacement therapy : Treatment for male hypogonadism

Treatment for muscle atrophy : HIV-related muscle wasting syndrome

Osteoporosis prevention : Promoting increased bone density

3. Quality advantages :

Batch consistency : Strict process control ensures consistency between batches.

Formulation performance : Excellent physicochemical properties ensure formulation quality.

Regulatory compliance : Complies with Chinese Pharmacopoeia, USP and other pharmacopoeia standards.

Global supply and service assurance

1. Production capacity :

Annual production capacity : Over 10 tons per year

Flexible manufacturing : Customized specifications and packaging requirements are acceptable.

Production capacity assurance : Multiple production lines ensure stable supply.

2. Quality Certification :

System Certification : Certified by ISO 9001 Quality Management System

Compliant with pharmacopoeia : Meets the standards of the Chinese Pharmacopoeia and the United States Pharmacopeia.

Complete documentation : Provides a complete package of high-quality documentation.

3. Logistics support :

Storage conditions : Temperature and humidity controlled warehouse, temperature 15-25℃

Packaging protection : Triple protection with aluminum foil bag + desiccant + vacuum packaging

Global Delivery : Partnering with international logistics companies such as DHL and FedEx

Why choose testosterone heptaate raw materials manufactured in China ?

Excellent purity : Over 99% high purity, with strict impurity control.

Advanced Technology : Automated production line with excellent process reproducibility

Stable quality : A strict quality control system ensures minimal batch-to-batch variation.

Reliable supply : Large-scale production capacity, timely delivery

Summary

Testosterone heptaate powder manufactured in China represents the high-quality standard of steroid active pharmaceutical ingredients . Through advanced production processes, rigorous quality control, and a stable supply system , it provides global pharmaceutical manufacturers with a high-quality, highly reliable raw material guarantee. Choosing Made in China means choosing professional quality and a stable supply .

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