— Supporting High-Standard Compliance in the Pharmaceutical Industry
We are pleased to announce that our n-Heptane (CAS No.: 142-82-5) has successfully obtained EU REACH 1000MT+ registration, marking a significant step forward in regulatory compliance, safety, and market access. This achievement highlights our commitment to regulatory excellence and sustainable supply in the global chemical market.
Applications of n-Heptane in the Pharmaceutical Industry
In the pharmaceutical sector, n-Heptane is an essential organic solvent widely used across analysis, purification, and formulation development. Its non-polar nature and high purity make it an ideal choice in various drug manufacturing processes:
- Solvent Functions: Used for extraction, crystallization, and separation processes, particularly effective in purifying active pharmaceutical ingredients (APIs) or intermediates.
- Chromatographic Analysis: Serves as a standard solvent for gas chromatography (GC) or high-performance liquid chromatography (HPLC), facilitating accurate analysis of drug components and impurities.
- Formulation Development: Acts as an excipient or process solvent in certain formulations, assisting coating, granulation, and drying processes.
- Cleaning Agent: Suitable for cleaning equipment or glassware, especially in water-sensitive production processes.
- Reference Material: Employed in pharmacopeial testing as a standard for instrument calibration or method validation.
Significance of REACH Registration
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is one of the strictest chemical regulatory frameworks worldwide. Achieving 1000MT+ registration allows us to legally supply over 1,000 tons of n-Heptane annually to the EU market, backed by comprehensive physical-chemical, toxicological, and environmental assessments.
This milestone reflects our dedication to quality and regulatory compliance while strengthening our competitive edge across the pharmaceutical, coatings, rubber, ink, and specialty chemical industries.
Safety and Compliance
n-Heptane is volatile and possesses neurotoxic potential. It should be handled in well-ventilated areas with appropriate protective measures. We uphold the principles of safety, environmental responsibility, and regulatory compliance to provide customers with high-standard chemical solutions and technical support.
For technical data sheets (TDS), MSDS, or regulatory support documents related to n-Heptane, please feel free to contact us.
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