Testosterone Base API

Product Overview

Testosterone Base API is a non-esterified component and appears as a white to off-white crystalline powder.

This API is highly purified and quality assured as it is produced under tightly controlled conditions and in accordance with stringent standards.

This API serves as the active core raw material for subsequent formulation and ensures consistency and stability in pharmaceutical manufacturing.

Testosterone Base API is used as a core raw material for the development of androgen-based formulations.

It is suitable for use in injectable, topical, and implantable dosage forms.

This API is valued for its clear chemical structure. It has high purity and reliable performance.

This makes it great for formulation development in regulated pharmaceutical settings.

Here are the key points about the quality, purity, and compliance of Testosterone Base API.

This is for regulated pharmaceutical manufacturing use.

Chemical Name (IUPAC): 17β-Hydroxyandrost-4-en-3-one
CAS Number: 58-22-0
Molecular Formula: C₁₉H₂₈O₂
Molecular Weight: 288.42 g/mol
Appearance: White to off-white crystalline powder
Identification Tests: IR, UV, and HPLC retention times
Assay Method: HPLC or GC
Assay / Purity: Meets pharmacopoeial limits.
Related Substances / Impurities: Controlled within specified limits.
Residual Solvents: As per ICH Q3C guidelines.
Elemental Impurities: Complies with ICH Q3D requirements.
Loss on Drying / Water Content: Within defined limits.
Residue on Ignition: Controlled as per specifications
Microbial Limits: Applicable limits for non-sterile APIs (N/A for sterility)
Regulatory Standards: USP/BP/EP/IP compliant

Testosterone Base API is packed in clean HDPE or fiber drums with double inner poly liners.

Drum sizes commonly range from small packs to 25 kg for industrial supply.

Containers are tightly sealed to protect from light and moisture.

The API is stored in a cool, dry area at controlled room temperature.

Actiza Pharmaceutical Pvt. Ltd. makes high-quality Testosterone Base API.

We have strong quality systems, modern facilities, and a worldwide supply network.

Actiza Pharma focuses on the manufacture of APIs and has backward integration.

This helps control processes better. It also guarantees steady quality.

Customers worldwide can rely on a dependable supply of Testosterone Base API.

We follow the quality guidelines set by WHO-GMP and ISO for the production of our Testosterone Base API.

Every batch goes through testing for purity, stability, and compliance to meet the strict standards set globally by pharmacopoeias and regulators.

Our facilities have advanced equipment. They also have controlled environments and skilled teams.

Operations and automation by zone lower risks. They also ensure consistency in API manufacturing.

We have a strong network of vendors. Our batch sizes are flexible, and we deliver on time.

This supports lasting partnerships. We focus on clear communication and provide reliable documentation.

We ensure a steady supply of bulk APIs for customers everywhere.