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Diisopropanolamine Manufacturers in India | Finar

Diisopropanolamine

Diisopropanolamine is a white to yellowish-white, waxy mass with low endotoxins making it suitable for many formulations. Its uses are significant as a buffering agent/alkalizer in pharmaceutical formulations, and it is mainly used in topical dosage forms. Finar, one of the best diisopropanolamine manufacturers in India, ensures a quality assessment process, including nitrosamine and elemental impurity risk assessment and many other parameters. All our products are manufactured under the most stringent environment, health, and safety standards.

We comply with the highest quality standards and are an ISO 9001:2015, 14001:2015, ISO 45001:2018, ISO/IEC 17025:2017, EXCiPACT and GMP certified company.

USP

Diisopropanolamine Manufacturers in India

Applications

It is used as a buffering agent/Alkalizer in pharmaceutical formulations. It is mainly used in topical dosage forms.

General Information

Pharmacopeia Status : USP

CAS No. : 110-97-4

EC No. : 203-820-9

Appearance/Description : White to yellowish white waxy mass.

Molecular Formula : C6H15NO2

Molecular Mass : 133.18 g/mol

Pack Mode

  • 1 kg, 2.5 kg HDPE container

Key Product Attributes

  • Manufacturing and packing under GMP environment

Quality and Regulatory Support

  • GMP and ISO certification
  • EXCiPACT certification
  • Nitrosamine impurity risk assessment
  • Elemental impurity risk assessment
  • Residual solvent declaration
  • Genotoxic impurity declaration
  • Vendor questionnaire and site audit
  • CMC documentation
  • Regulatory queries

Marketed Formulation

  • Many formulations are marketed with this excipient

Product Specifications

Particulars Limit
Descripton White to yellowish white waxy mass.
Identification A(By IR) IR spectra of the sample should be concomitant with IR spectra of the standard.
Assay 98.0% - 102.0% (On anhydrous basis)
Limit of triisopropanolamine NMT 1.0%
Water NMT 0.50%

Stability and Storage Conditions

Stable under recommended storage conditions. Sensitive to air. Hygroscopic.

Safety and Handling Information

Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Provide appropriate exhaust ventilation at places where dust is formed.

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