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The purpose of this article and attached white paper is to explain how instrumental color measurement enhances quality control of tablets, pills, capsules, and caplets in bio-pharmaceutical manufacturing by replacing subjective visual inspection with objective, CIE-based spectrophotometric analysis, ensuring product uniformity, regulatory compliance, and global consistency across the manufacturing lifecycle.

Important Notes:

  • Color Is a Process Indicator, Not Just an Appearance Attribute

    Small shifts in L*, a*, b*, or ΔE* values may signal coating variability, pigment dispersion issues, thermal exposure, moisture uptake, degradation, or supplier inconsistencies—often before defects become visually obvious.

  • Regulatory and Data Integrity Alignment Is Essential

    Instrumental color measurement aligns with CIE standards, USP <1061>, EP 2.2.2, and supports 21 CFR Part 11 / EU GMP Annex 11 compliance through secure electronic records and validated instrumentation.

  • Geometry and Sample Handling Matter for Dosage Forms

    Curved, glossy, and small pharmaceutical samples require proper illumination geometry and secure positioning. UltraScan VIS (diffuse/8° integrating sphere) and Agera L2 (0°/45°c geometry) include dedicated tablet and capsule holders to ensure repeatable, auditable measurements.

Color is a critical quality attribute in solid oral dosage manufacturing and directly reflects coating integrity, formulation consistency, and process control. Visual inspection is subjective and unreliable, while instrumental spectrophotometry provides objective, traceable, and regulatory-aligned color data using CIE L*, a*, b* standards. HunterLab’s UltraScan VIS and Agera L2 enable pharmaceutical manufacturers to control appearance across tablets, pills, capsules, and caplets—improving global consistency, reducing rework, supporting compliance (USP, EP, 21 CFR Part 11), and protecting brand integrity.

To learn more, download the complete white paper below!

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

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