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Pregabalin API

Name of Product Pregabalin
CAS No 148553-50-8
Therapeutic use:- General Api
Grade BP/USP
Form:- API Powder
Status Commercial

Product Overview

Pregabalin API usually appears as a white or slightly off-white powder.

It is made according to strict cGMP guidelines and is a small molecule API.

It has a uniform particle size and high purity. This API is known for its purity.

Therapeutic Applications

Pregabalin API is used in the development and manufacturing of pharmaceutical formulations.

It is produced under controlled conditions with consistent quality, defined physicochemical properties, and reliable batch-to-batch performance.

The API is valued for its stability, purity profile, and suitability for regulated pharmaceutical production processes.

Specification Parameters

The Pregabalin API specifications set out clear guidelines for its identity, purity, and quality.

  • Chemical Name (IUPAC): (S)-3-(aminomethyl)-5-methylhexanoic acid

  • CAS Number: 148553-50-8

  • Molecular Formula: C₈H₁₇NO₂

  • Molecular Weight: 159.23 g/mol

  • Appearance: White to off-white crystalline powder

  • Identification Tests: IR spectroscopy and HPLC retention time

  • Assay Method: HPLC

  • Assay (Purity): Typically 98.0%–102.0% on a dried basis

  • Related Substances / Impurities: Controlled by validated HPLC limits.

  • Residual Solvents: As per ICH Q3C guidelines.

  • Elemental Impurities: Complies with ICH Q3D requirements.

  • Loss on Drying / Water Content: Not more than the specified limit.

  • Residue on Ignition: Within pharmacopeial limits

  • Microbial Limits: As per pharmacopeial standards.

    Packaging & Storage

    Pregabalin API is typically packaged in HDPE or fiber drums with double inner polyethylene liners.

    These are usually 25 kg quantities. For API storage, choose a cool, dry, and clean place with a controlled temperature.

    Besides, the product can be preserved at a high level of quality and freshness if kept and handled in conditions free of moisture and away from direct light.

    Why Choose Us

    Actiza Pharmaceutical Pvt. Ltd. is a reliable source for high-quality Pregabalin API.

    We ensure strict quality control and maintain a steady supply chain.

    Quality Focus

    Every Pregabalin API batch follows WHO-GMP and ISO standards.

    We make thorough checks at each stage to confirm purity, consistency, and safety.

    Advanced Facilities

    Our modern manufacturing units are set up with automated systems and clean environments.

    This helps us control the processes and ensure our Pregabalin API is stable.

    Moreover, it reduces the risk of contamination and means that each batch is of the same high standard.

    Flexible Supply

    We handle various order sizes and provide secure bulk packaging.

    We provide efficient storage and logistics. This helps us deliver Pregabalin API on time, both in India and worldwide.

    Trusted Support

    Actiza Pharmaceutical Pvt. Ltd. offers clear communication, technical help, and complete documentation support.

    This allows customers to oversee sourcing, audits, and partnerships, so they feel completely confident.