MenuChlorobutanol hemihydrate – Antimicrobial preservative for high end sterile pharmaceutical formulations
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Chlorobutanol hemihydrate – Antimicrobial preservative for high end sterile pharmaceutical formulations

1. General introduction to Chlorobutanol hemihydrate

Chlorobutanol hemihydrate is an antimicrobial preservative excipient specifically designed for sterile pharmaceutical formulations, including ophthalmic solutions, injectable products and topical preparations. With its broad-spectrum antimicrobial activity, it plays a critical role in maintaining microbiological safety throughout the product lifecycle.

In advanced pharmaceutical manufacturing, Chlorobutanol hemihydrate is not merely a preservative but a strategic excipient, ensuring sterility assurance, enhancing formulation stability and meeting stringent regulatory requirements. Its balanced profile between antimicrobial efficacy and formulation compatibility makes it particularly suitable for sensitive systems.

2. Chemical composition of Chlorobutanol hemihydrate

  • Chemical name:Chlorobutanol hemihydrate
  • Molecular formula:C₄H₇Cl₃O·0.5H₂O
  • Form: Crystalline powder
  • Purity:≥ 99%

This composition ensures effective antimicrobial performance and stability in aqueous pharmaceutical systems.

3. Key advantages of Chlorobutanol hemihydrate

  • Broad-spectrum antimicrobial activity: Inhibits bacteria and fungi, ensuring microbiological safety
  • Effective at low concentrations: Minimizes impact on overall formulation
  • High compatibility: Suitable for a wide range of sterile dosage forms
  • Stability in aqueous systems: Maintains efficacy over time
  • Extended product shelf life: Reduces contamination risks
  • Pharmacopeial compliance: Meets international regulatory standards

4. Applications of Chlorobutanol hemihydrate

Chlorobutanol hemihydrate is widely used across multiple dosage forms due to its stabilizing and antimicrobial properties:

  • Ophthalmic solutions: Preserves sterility and prevents microbial contamination
  • Injectable formulations: Ensures microbiological safety in sterile systems
  • Topical preparations: Prevents contamination in creams, gels, and ointments
  • Nasal and otic solutions: Inhibits microbial growth
  • Multi-dose formulations: Maintains sterility during repeated use

5. Commercial products using Chlorobutanol hemihydrate

6. Product contact information

For more information aboutChlorobutanol hemihydrate supply, please contact us:

  • Hotline: +84 (0) 834 560 500
  • Email: director@biorichgroup.com
  • Website: www.biorichgroup.com
  • Sample / COA request:Please contact us via email to receive product samples and the latest Certificate of Analysis (COA).

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