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Hydralazine Hcl API

Name of Product Hydralazine Hcl
CAS No 304-20-1
Therapeutic use:- Anti Hypertensive
Grade BP/USP
Form:- API Powder
Status Commercial

Product Overview

Hydralazine HCl API is a top-notch active pharmaceutical ingredient.

It comes as a white crystalline powder. It is made under strict GMP conditions and meets USP and EP standards.

The API provides high purity, stable composition, and reliable performance.

It offers complete regulatory support, ensuring DMF and EDMF compliance.

Therapeutic Applications

Hydralazine HCl API is used to make oral and injectable medicines.

It’s good for creating cardiovascular formulations that need a direct-acting vasodilator API.

The API helps create different formulations. This is especially useful for pharmaceutical companies making regulated products. 

Specification Parameters

This section looks at the main features of Hydralazine HCl API.

It also follows trusted pharmacopoeia guidelines to set clear safety standards.

  • Chemical Name (IUPAC): 1-Hydrazinylphthalazine hydrochloride

  • CAS Number: 304-20-1

  • Molecular Formula: C₈H₉ClNâ‚„

  • Molecular Weight: ~196.64 g/mol

  • Appearance: White to off-white crystalline powder

  • Identification Tests: Use IR, UV, or HPLC to compare with the reference standard.

  • Assay Method: HPLC (potency is within the specified limits set by the pharmacopoeia).

  • Related Substances / Impurities: Limits for specific and total impurities are controlled by HPLC.

  • Residual Solvents: Complies with ICH Q3C limits

  • Elemental Impurities: Meet ICH Q3D requirements

  • Loss on Drying / Water Content: Must stay within set moisture limits.

  • Microbial Limits: Meets pharmacopeial limits (or N/A for non-sterile APIs).

    Packaging & Storage

    Hydralazine HCl API needs careful packaging and storage to stay in top quality.

    HDPE or fiber drums are commonly used. These drums have a double layer of polyethylene for better safety against moisture and impurities.

    Store them in a cool, dry place, away from direct light, with lids tightly closed.

    Why Choose Us

    Actiza Pharmaceutical Pvt. Ltd. is a reliable API manufacturer in India. We provide high-quality hydralazine HCl.

    Global Standards

    Our Hydralazine HCl API meets global quality standards. We follow certified WHO, GMP, and ISO standards.

    This lets us offer pure, safe, and reliable products from our modern automated facilities.

    Advanced Manufacturing

    Our plants feature high-speed machines and automated packaging.

    We also use separate zones for various tasks.

    This will help production run smoothly, reduce contamination, and provide a steady API supply for clients around the globe.

    End-to-End Support

    We oversee all aspects of the API. This covers sourcing raw materials, storing them, and delivering them.

    Our skilled team and integrated systems are always ready. We make communication, tracking, and regulatory compliance easy.

    Customer Focus

    We deliver flexible order sizes and competitive pricing on schedule.

    Our support team covers multiple time zones, providing clear guidance and assistance whenever needed.