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Estradiol Cypionate API

Name of Product Estradiol Cypionate
CAS No 313-06-4
Therapeutic use:- Hormones
Grade BP/USP
Form:- API Powder
Status Commercial

Product Overview

Estradiol Cypionate API is essentially a synthetic estrogen of the female hormone.

It is used primarily to produce hormone medications. It is an oil-soluble ester of estradiol.

This API is known for its reliable quality. It works well with receptors and fits easily into controlled processes in pharmaceutical formulation.

Therapeutic Applications

Estradiol Cypionate API serves as the active ingredient in formulating estrogen replacement therapies.

It’s used to make medicines that help with issues like estrogen deficiency, balancing hormones, and providing long-term estrogen support.

Specification Parameters

These parameters play a vital role in the quality and safety of Estradiol Cypionate API.

They ensure the purity and quality of Estradiol Cypionate.

  • Chemical Name (IUPAC): Estradiol 17-cyclopentanepropionate

  • CAS Number: 313-06-4

  • Molecular Formula: C₂₆H₃₆O₃

  • Molecular Weight: 396.57 g/mol

  • Appearance: White to off-white solid powder

  • Identification tests: IR, HPLC retention time, or spectral matching

  • Assay Method: HPLC or GC, as per pharmacopeial standards

  • Assay / Purity: Typically not less than 99.0%

  • Related Substances: Controlled limits for known and unknown impurities.

  • Residual Solvents: Tested by GC, compliant with ICH Q3C limits.

  • Elemental Impurities: Evaluated as per ICH Q3D risk-based approach.

  • Loss on Drying / Water Content: Not more than 1.0%

  • Melting Point: Within the specified pharmacopeial range

  • Solubility: Practically insoluble in water; oil-soluble.

  • Microbial Limits: Kept in check based on pharmacopeial requirements, where relevant.

    Packaging & Storage

    Estradiol Cypionate API is supplied in drums made from either rigid fiber or HDPE, available in sizes of 5 kg, 10 kg, and 25 kg.

    To maintain the stability and quality of the product, the containers are sealed in such a way that no moisture or light can enter.

    The API is kept somewhere cool and dry that doesn’t get direct sunlight.

    Why Choose Us

    Actiza Pharmaceutical Pvt. Ltd. provides top-notch Estradiol Cypionate API.

    We maintain tight control over our manufacturing and meet global standards in the process.

    Quality Focus

    We make Estradiol Cypionate API with strict quality controls.

    Every batch adheres to approved processes, undergoes testing, and keeps records of controls.

    This ensures the active ingredient is pure, consistent, and works reliably.

    API Expertise

    Our dedicated API team manages everything from raw material control to final release.

    Backward integration is very helpful. It aligns our specs, ensures a stable supply, and enhances our process knowledge.

    Modern Facilities

    We run modern facilities with great equipment, climate control, and automated systems.

    Our zone-based operations, clean utilities, and skilled teams work as one.

    They reduce risks, prevent contamination, and ensure the smooth production of APIs on a large scale.

    Global Support

    We’re flexible with order quantities and can deliver on your schedule.

    Our regulatory-ready documents and export expertise give partners the confidence to take the next step.