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Chenodeoxycholic Acid API

Name of Product Chenodeoxycholic Acid
CAS No 474-25-9
Therapeutic use:- cosmetic
Grade BP/USP
Form:- API Powder
Status Commercial

Product Overview

Chenodeoxycholic Acid comes in the category of bile acid active pharmaceutical ingredients (APIs).

Chenodeoxycholic Acid is a major bile acid derived from cholesterol in the liver.

It is produced for the use of pharmaceutical and contract manufacturers.

Chenodeoxycholic Acid is required at the API level only.

Chenodeoxycholic Acid requires formulation, testing, and approval as a finished pharmaceutical product before its use as a drug.

Therapeutic Applications

Chenodeoxycholic acid is employed as an API in drugs that work on bile and fat digestion.

Products produced from this API may be developed for:

  • Dissolving specific types of cholesterol gallstones

  • Treatment of rare bile acid synthesis disorders

  • Supporting normal bile acid balance in certain inherited liver conditions

    Within these products, chenodeoxycholic acid is-

    • Enhance the combination of bile acids in the body

    • Decrease the build-up of more toxic bile acid species

    • Support fat digestion and absorption

      Through the restoration of the normal pool of bile acids, the ultimate drug will work to protect the liver and ease symptoms associated with poorly draining bile or unusual bile acids.

      Dose, duration of treatment, and population can be defined by the ultimate drug or by regulations.

      Specification Parameters

      • CAS Number: 474-25-9

      • Chemical Name: 3α,7α-Dihydroxy-5β-cholan-24-oic acid

      • Molecular Formula: Câ‚‚â‚„Hâ‚„â‚€Oâ‚„

      • Molecular Weight: 392.57 g/mol

      • Appearance: White to off-white crystalline powder 

      • Solubility: Practically insoluble in water, Soluble in ethanol, methanol, and many organic solvents

      • Purity (HPLC): ≥ 98.0 % (API grade; tighter limits can be agreed)

      • Specific Rotation: As specified in the agreed specification, within the specified range.

      • Melting Point: Approx. 165 – 167 °C (typical range)

      • Loss on Drying: Not more than 0.5 % Residue on Ignition/Sulfated Ash: Not more than 0.5 % or as agreed.

      • Heavy Metals/Elemental Impurities: Within specified limits based on the latest guidelines.

        Identification Tests:

        • IR spectrum matches reference standard

        • HPLC retention time matches the reference standard

        • Additional ID tests as per the validated method

          All batch-specific values are provided in the Certificate of Analysis.

          Packaging & Storage

          Chenodeoxycholic acid is packed in sealed, light-protective containers.

          Typical packs are HDPE bottles or drums with inner polyethylene or foil-lined bags.

          Each container is clearly labelled with:

          • Product name

          • Batch or lot number

          • Net weight

          • Manufacturing date

          • Retest or expiry date

            Storage conditions:

            • Store in a cool, dry place

            • Protect from strong light, heat, and moisture

            • Keep the container tightly closed when not in use

              When stored as advised and in the original packaging, chenodeoxycholic acid remains within specification for the full validated shelf life stated on the CoA.

              Why Choose Us

              We are able to provide chenodeoxycholic acid of high purity and consistency as an API.

              Our process is carried out under strictly observed quality systems and GMP standards.

              A comprehensive documentation package is supplied, which includes a Certificate of Analysis and Safety Data Sheets.

              We can modify our specifications to comply with your in-house standards, if possible.

              Our technical group is also there to help in case of queries regarding handling, solubility, and processing.