Titanium Dioxide testing & analysis

Ensuring pharmaceutical grade Titanium Dioxide (TiO₂) compliance

 

In the healthcare and pharmaceutical industry, the quality and purity of raw materials like Titanium Dioxide (TiO₂) is critical. Whether used for UV protection in topical formulations or as a coating for tablets, TiO₂ must meet stringent regulatory requirements.

 

At RSSL, we specialise in full monograph testing of Titanium Dioxide, ensuring compliance with the United States Pharmacopoeia (USP), European Pharmacopoeia (Ph. Eur.) and Japanese Pharmacopoeia (JP).

 

Our expert team utilises advanced wet chemistry techniques, delivering precise and reliable results.

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+44 (0)118 9184000
lifesciencesales@rssl.com
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Comprehensive testing for Titanium Dioxide purity

 

Titanium Dioxide (TiO₂) is a key pharmaceutical excipient that demands rigorous purity testing. 


Each of the regional pharmacopeial standard has different requirements and methodologies. RSSL’s expertise in titrations, gravimetric analysis and complex wet chemistry techniques along with state-of-the-art facilities enables the handling of challenging assays with high precision whilst still ensuring materials meet USP, Ph. Eur. and JP regulatory standards. 

  • Pharma Dev R2 6157 Hr

    United States Pharmacopoeia (USP)

    The USP assay employs the Jones reductor method to precisely determine TiO₂ content

     

    1. 1. Reduction – Amalgamated zinc reduces titanium ions from Ti⁴⁺ to Ti³⁺.

     

    1. 2. Oxidation – The Ti³⁺ solution reacts with ferric ammonium sulfate, converting back to Ti⁴⁺.

     

    1. 3. Titration – Using potassium permanganate (KMnO₄) to measure TiO₂ purity.
  • Pharma Chem RSSL 23 R2 1775 HR (35)

    European Pharmacopoeia (EP)

    The EP assay follows a controlled redox titration approach:

     

    1. 1.   Dissolution – TiO₂ is carefully dissolved in an acidic medium with heat

     

    1. 2.   Reduction – Amalgamated zinc column conversion from Ti⁴⁺ to Ti³⁺.

     

    1. 3.   Oxidation – Ti³⁺ reacts with ferric ammonium sulfate, forming Ti⁴⁺.

     

    1. 4.   Titration – Ammonium and cerium nitrate solution determines TiO₂ content, with Ferroin as the indicator.
  • Pharma Chem RSSL 23 R2 1775 HR (20)

    Japanese Pharmacopoeia (JP)

    The JP assay employs a gravimetric approach to assess TiO₂ purity, this method provides a highly accurate, weight-based purity assessment of TiO₂.


    1.   Conversion – TiO₂ is rendered soluble via potassium pyrosulfate fusion in platinum crucibles.


    2.   Purification – Includes hydrogen sulfide treatments and final precipitation with Cupferron.


    3.   Quantification – Purity is determined through ignition in a muffle furnace.

We also perform complementary full monograph analysis covering a number of methods including;

 

  • Elemental Impurities
  • Organic Impurities
  • Acidity/Alkalinity
  • Identification
  • Loss on Ignition (LOI)
  • Loss on Drying (LOD)

 

Our rigorous wet chemistry techniques ensure your Titanium Dioxide data meets the highest pharmaceutical standards—guaranteeing safety, compliance and performance. 

Get in touch to find out how we can transform complex chemistry into reliable results for you

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