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FAQ – I Need to Measure Color and Turbidity According to EP 2.2.1 and EP 2.2.2. How Can I Do This and Are You Compliant?


Answer

Yes. HunterLab offers solutions for pharmaceutical laboratories requiring measurements in accordance with EP 2.2.1 (Clarity and Degree of Opalescence of Liquids) and EP 2.2.2 (Degree of Coloration of Liquids). The best solution depends on your application requirements. For customers requiring full CIE visible wavelength coverage, UltraScan® VIS is the preferred solution. For customers requiring visible color measurement and turbidity/opalescence evaluation in a cost-effective platform, Vista® L2 is often recommended.

What Is the Best HunterLab Solution?

UltraScan® VIS – Preferred for Full CIE Compliance

UltraScan VIS is the preferred solution when full visible spectral measurement across the complete CIE visible range is required. UltraScan VIS provides:

  • Full CIE visible spectral measurement.
  • EP 2.2.2 Method III instrumental color measurement.
  • EP 2.2.1 clarity and opalescence evaluation.
  • Transmission color measurement.
  • CIELAB and spectral data analysis.
  • Pharmaceutical method development and validation support.
  • Measurement of both transparent and opaque pharmaceutical materials.

UltraScan VIS is frequently selected by pharmaceutical laboratories that require maximum flexibility, complete visible spectral characterization, or alignment with internal quality and regulatory requirements that specify full visible wavelength measurement.

Vista® L2 – Preferred for Visible Color and Turbidity

Vista L2 is designed specifically for liquid color and turbidity measurements and provides:

  • Transmission color measurement.
  • Turbidity measurement.
  • EP 2.2.2 instrumental color evaluation.
  • EP 2.2.1 clarity and opalescence evaluation.
  • Simultaneous color and turbidity measurement.
  • Compact footprint and simplified operation.

Vista L2 is often selected when the primary need is routine pharmaceutical liquid color and turbidity testing rather than complete spectral characterization.

How Much Does It Cost?

Vista® L2

Starting at approximately $14,965. Ideal for:

  • Pharmaceutical liquid color measurement.
  • Turbidity and opalescence evaluation.
  • Routine quality control testing.
  • Laboratories seeking a dedicated liquid measurement solution.

UltraScan® VIS

Starting at approximately $22,420. Ideal for:

  • Full CIE visible wavelength measurements.
  • Pharmaceutical color applications requiring complete spectral characterization.
  • Method development and validation.
  • Laboratories seeking maximum flexibility across both transmission and reflectance applications.

Best Practices

  • Establish validated procedures for each product and formulation.
  • Correlate instrumental measurements with existing visual methods during method development.
  • Use consistent sample cells and path lengths.
  • Standardize sample temperature and handling procedures.
  • Validate the measurement method for the intended application.
  • Utilize certified reference standards and routine instrument standardization.
  • Document all measurements in accordance with GMP and quality system requirements.
  • Establish product-specific acceptance criteria.
  • Verify instrument suitability as part of the method validation process.

Why Measure Instrumentally?

Traditional EP methods were originally based on visual comparison techniques. While visual methods remain valid, instrumental measurements provide significant advantages:

  • Improved repeatability.
  • Reduced operator subjectivity.
  • Enhanced traceability.
  • Electronic record keeping.
  • Improved global consistency between facilities.
  • Better support for validation and compliance activities.
  • Easier trending and long-term process monitoring.

Instrumental measurements provide objective, quantitative data that can improve confidence in pharmaceutical quality decisions while reducing variability associated with human visual assessments.

Key Takeaway

If your application requires full CIE visible wavelength measurement, UltraScan® VIS is the preferred HunterLab solution and provides the most comprehensive platform for EP 2.2.1 and EP 2.2.2 applications. If your primary requirement is routine pharmaceutical liquid color and turbidity measurement, Vista® L2 provides a cost-effective solution that combines color and turbidity testing in a single instrument. Both solutions can support pharmaceutical quality programs when properly validated for the intended application.

Do you need more information? Submit a ticket and a support team member will reach out to you soon!

To learn more about Color and Color Science in industrial QC applications, click here: Fundamentals of Color and Appearance

Keywords: I Need to Measure Color and Turbidity According to EP 2.2.1 and EP 2.2.2. How Can I Do This and Are You Compliant?