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This Pharma Color Guide introduces how color is measured according to Ph. Eur. and USP and includes a ready-to-use method package for the UV/VIS Excellence spectrophotometer. |
In pharmaceutical manufacturing and quality control, the accurate measurement and analysis of color are paramount. Color not only serves as an immediate visual indicator of a product’s identity, stability, and quality but also plays a critical role in ensuring compliance with pharmacopeial standards. The precise evaluation of color according to pharmacopeia guidelines is essential for guaranteeing that pharmaceutical products meet rigorous regulatory requirements and are safe for patient use.
The pharmacopeia, which includes authoritative guidelines such as the United States Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.), sets standardized methods for color measurement to ensure consistency and accuracy.
This guide will help you navigate through these guidelines. It contains a step-by-step description and ready-to-use methods for color measurements according to Ph. Eur. chapter 2.2.2 and USP chapter 631 to be used with UV/VIS Excellence spectrophotometer.
Table of Contents:
1. Introduction
2. European Pharmacopoeia (Ph. Eur.) Color Scale
3. United States Pharmacopeia (USP) Color Scale
4. Common Considerations for Both Scales
4.1 Allowed Analysis Techniques
4.2 Instrumental Method
5. METTLER TOLEDO Solution – Ready-to-Use Methods
5.1 Workflow Ph. Eur. Color Scale
5.2 Workflow USP Color Scale
6. Appendix
6.1 Calibration Procedure
