Description

Technical Parameters

Core Introduction to Testosterone Undecanoate Raw Material Powder

Pharmaceutical-grade raw material | Testosterone undecanoate , made in China

Chemical name : 17β-undecanoyloxy-4-androsten-3-one

CAS No .: 5949-44-0

EINECS ID : 227-707-5

Molecular formula : C₃₀H₄₈O₃

Molecular weight : 456.71

Melting point : 39-41℃

Appearance : White crystalline powder

Purity : ≥99% (HPLC detection)

Core Effects

Testosterone undecanoate is an ultra-long-acting testosterone ester compound . Due to its unique undecanoate group and excellent pharmacokinetic properties , it is widely used for long-acting testosterone replacement therapy, male hypogonadism, and chronic disease rehabilitation .

✅Long -lasting mechanism of action :

Esterification modification : Undecanoate groups provide an extremely long half-life.

Lymphatic absorption : Absorbed via the intestinal lymphatic system, avoiding the first-pass effect.

Stable blood drug concentration : The half-life is approximately 20-30 days, and the blood drug concentration remains stable.

✅Quality advantages of Chinese manufacturing :

Purity Guarantee : Raw material purity ≥ 99.5%, conforming to USP standards.

Crystal form control : Stable β-crystal form ensures consistent dissolution.

Chiral purity : Optical purity of chiral centers ≥ 99.8%

✅Global supply assurance :

Cold chain logistics : constant temperature transportation at 15-25℃ to ensure stability.

Multiple packaging options: 1kg/aluminum foil bag, 5kg/drum.

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

Production process and quality assurance

1. Advanced synthesis process :

Esterification reaction : Efficient esterification of testosterone with undecanoyl chloride under mild conditions

Purification process : Recrystallization combined with column chromatography to obtain high-purity products.

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 features and advantages

1. Efficacy characteristics :

Potent androgen : Androgenic activity is 1.1 times that of testosterone propionate.

Long-lasting effect : Half-life of 20-30 days, suitable for injection administration every 10-14 weeks.

Effective for oral administration : Utilizes a unique lymphatic absorption pathway, resulting in high oral bioavailability.

2. Key Features and Advantages :

Esterification protection : Undecanoate groups provide an ultra-long half-life

Lymphatic absorption : Avoids the first-pass effect in the liver and improves bioavailability.

Mature production process : The synthesis route is mature and the quality is stable.

3. Advantages of use :

Convenient medication use : oral or long-acting injection, high patient compliance.

Stable blood drug levels : Small fluctuations in blood drug concentrations and low risk of side effects.

Various dosage forms : suitable for oral capsules, injections, and other dosage forms.

Why choose testosterone undecanoate manufactured in China ?

Long -lasting effect : Half-life of 20-30 days, stable blood drug concentration

High purity : Raw material purity ≥99.5%, with strict impurity control.

Made in China : Manufactured to cGMP standards, reliable quality

Stable supply : Large-scale production capacity ensures timely and reliable delivery.

Summary

Made in China, testosterone undecanoate powder represents the high-quality standard of ultra-long-acting testosterone ester raw materials . Through advanced synthesis processes, strict quality control, and a stable supply system , it provides high-quality, high-purity raw materials for global hormone preparation production . Choosing Made in China means choosing professional quality and reliable assurance .

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