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1

á631ñ COLOR AND ACHROMICITY

Change to read:
▲
INTRODUCTION

The purpose of this chapter is to provide well-controlled methods for the assessment of color and achromicity of uniform
liquid samples. The methods described in this chapter may be applied to the liquid phase of dispersed systems in cases where
the dispersed phase can be removed prior to color measurements. Color is an organoleptic characteristic, which means that
the value is based on the human response to stimuli. To reliably evaluate color, it is important to control both the illumination
and observation parameters. By using a characteristic response for a standard observer, it is possible to perform precise
instrumental evaluations of color. This chapter provides guidance for both an organoleptic assessment (Method I) and an
instrumental assessment (Method II) of color and achromicity in liquid samples.▲ (USP 1-May-2021)
▲ (USP 1-May-2021) Color may be defined as an observer’s▲ (USP 1-May-2021) perception of▲ (USP 1-May-2021) or subjective response
▲ ▲ ▲
▲
to a stimulus of radiant energy▲ (USP 1-May-2021) in the visible spectrum extending over the ▲wavelength range▲ (USP 1-May-2021) of
400–700 nm. ▲▲ (USP 1-May-2021) Perceived color is a function of three variables: spectral properties of the object, ▲▲ (USP 1-May-2021)
spectral ▲power distribution▲ (USP 1-May-2021) of the source of illumination, and visual ▲perception▲ (USP 1-May-2021) of the observer.
Two objects are said to have a color match for a particular source of illumination when an observer cannot detect a color
difference. Where a pair of objects exhibit a color match for one source of illumination and not another, they constitute a
metameric pair. Color matches of two objects occur for all sources of illumination if the absorption and reflectance spectra of

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the two objects are identical.
Achromicity or colorlessness is one extreme of any color scale for transmission of light. It implies the complete absence of
color; therefore, the visible spectrum of the ▲sample▲ (USP 1-May-2021) lacks absorbances. For practical purposes, the observer in
this case perceives little if any absorption taking place in the visible spectrum ▲and is unable to discern the difference between
an almost colorless sample and a colorless reference.▲ (USP 1-May-2021)
ci
Change to read:
COLOR ATTRIBUTES ▲AND COLOR SPACE COORDINATES▲ (USP 1-MAY-2021)
ffi
Because the sensation of color has both a subjective and an objective part, color cannot be described solely in
spectrophotometric terms. The common attributes of color therefore cannot be given a one-to-one correspondence with
spectral terminology.
Three attributes are commonly used to identify a color: 1) hue ▲(angle)▲ (USP 1-May-2021), or the ▲color dimension dominant in
its purest form▲ (USP 1-May-2021), such as red, yellow, blue, green, and intermediate terms; 2) ▲lightness,▲ (USP 1-May-2021) or the
quality that distinguishes a light color from a dark one; and 3) chroma, or the quality that distinguishes ▲an intense▲ (USP 1-May-2021)
O

color from a weak one, such as the extent to which a color differs from a gray of the same ▲lightness.▲ (USP 1-May-2021)
The three attributes of color may be used to define a three-dimensional color space in which any color is located by its
coordinates. The color space chosen is visually uniform if the geometric distance between two colors in the color space is
▲
correlated with the perceived difference between the two colors.▲ (USP 1-May-2021) Cylindrical coordinates are often chosen for
convenience. Points along the ▲vertical▲ (USP 1-May-2021) axis represent ▲the lightness▲ (USP 1-May-2021) from dark to light (or black to
white) and have indeterminate hue ▲(angle)▲ (USP 1-May-2021) and no chroma. Focusing on a cross-section perpendicular to the
▲
lightness▲ (USP 1-May-2021) axis, hue is determined by the angle about the long axis and chroma is determined by the
▲
geometric▲ (USP 1-May-2021) distance from the ▲vertical▲ (USP 1-May-2021) axis. Red, yellow, green, blue, ▲▲ (USP 1-May-2021) and
intermediate hues are ▲differentiated by various hue▲ (USP 1-May-2021) angles. Colors ▲of the same hue angle▲ (USP 1-May-2021) become
more intense ▲(i.e., chromatic) as they move further from the vertical axis (larger chroma).▲ (USP 1-May-2021) For example, colorless
or achromic water has an indeterminate hue ▲angle,▲ (USP 1-May-2021) high ▲lightness,▲ (USP 1-May-2021) and ▲little to▲ (USP 1-May-2021)
no chroma. If a colored solute is added, the water takes on a particular hue ▲(angle)▲ (USP 1-May-2021). As more is added, the color
becomes darker, more intense, or deeper; that is, the chroma ▲▲ (USP 1-May-2021) increases and ▲lightness▲ (USP 1-May-2021) decreases.
However, if the solute is a neutral color, such as gray, the ▲lightness▲ (USP 1-May-2021) decreases, ▲▲ (USP 1-May-2021) no increase in
chroma ▲occurs,▲ (USP 1-May-2021) and the hue ▲(angle)▲ (USP 1-May-2021) remains indeterminate.
Laboratory spectroscopic measurements can be converted to measurements of the ▲▲ (USP 1-May-2021) color attributes ▲by using
the response factors for a standardized observer.▲ (USP 1-May-2021) Spectroscopic results ▲▲ (USP 1-May-2021) are weighted by three
distribution functions to yield the tristimulus values X, Y, and Z (▲for additional information,▲ (USP 1-May-2021) see Color—
Instrumental Measurement á1061ñ). ▲▲ (USP 1-May-2021)
The tristimulus values are not coordinates in a visually uniform color space; however, ▲they can be transformed into a more
uniform chroma–hue color space known as the CIELAB color space, defined by the International Commission on Illumination
(CIE) in 1976. Also known as CIE L*a*b* or sometimes abbreviated as simply "Lab" color space, CIELAB was designed so that
the same amount of numerical change in these values corresponds to roughly the same amount of visually perceived change.
The resulting L*, a*, b*, C*ab, and h*ab values indicate the following:
• L* is the lightness coordinate. L is always positive and ranges from 0 to 100; 100 is the colorless (white) standard and 0 is
the zero (black) standard.
• a* is the red/green coordinate. +a* is red, and −a* is green.
• b* is the yellow/blue coordinate. +b* is yellow, and −b* is blue.
• C*ab is the chroma in the (a*, b*) plane. C*ab = [(a*)2 + (b*)2 ]1/2.

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• h*ab is the hue angle in the (a*, b*) plane, measured from the a* axis increasing counterclockwise, and is reported as a
value from 0 to 360 degrees. The hue angles for the elementary colors are approximately 25 (red), 92 (yellow), 162 (green),
220 (cyan), 271 (blue), and 337 (magenta) degrees.
Additionally, the difference between two points in the CIELAB color space (ΔE*) can be calculated as follows:

* *2 *2 *2
ΔE = ΔL + Δa + Δb

Slight differences in colors are not perceptible in visual comparisons. Although it is possible for the human eye to differentiate
between colors with a ΔE* of about 1, it is frequently difficult for an observer with normal color vision to reliably differentiate
between colors with a ΔE* of less than 3. Therefore, it is preferable to rely on quantitative assessment of color and color
differences when precise, reliable comparisons are required.▲ (USP 1-May-2021)

Change to read:
COLOR DETERMINATION AND STANDARDS

The perception of color and color matches is dependent on conditions of viewing and illumination. Determinations should
be made using diffuse, uniform illumination under conditions that reduce shadows and ▲minimize▲ (USP 1-May-2021) non-spectral
reflectance. ▲▲ (USP 1-May-2021) Liquids should be compared in matched color-comparison ▲containers that are transparent to the
illumination light. Either organoleptic (qualitative) or instrumental (quantitative) assessment of color may be used.

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Containers for Liquid Samples and Matching Fluids
For liquid samples, the containers used to hold the samples during the color measurements should be non-absorbing in the
400–700 nm range and must be identical for the sample and matching fluids. The containers may be round or square, and the
diameter or depth of the container may be adjusted to provide a shorter path length for darker samples or a longer path length
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for lighter samples. The use of cuvettes or glass tubes with a path length of about 10 mm is recommended.

Turbid and Opaque Samples

When using transparent color-matching fluids, the color evaluation of the sample should be based on evaluation of the
ffi
clarified sample. If the sample is turbid or opaque, the dispersed phase should be removed by centrifugation or filtration before
evaluating the color. If the sample or matching fluid contains air bubbles or foam, these should be removed by centrifugation
before evaluation of the color.▲ (USP 1-May-2021)

Matching Fluids
O

The colors of standards should be as close as possible to those of test specimens for quantifying color differences. ▲Any
well-defined and well-characterized matching fluid is permitted (1). For example, matching fluids may be prepared according
to Table 1 or may be prepared as described in the European Pharmacopoeia (2) (2.2.2. Degree of Coloration of Liquids) or Chinese
Pharmacopoeia (3) (Appendix IX, Colour of Solution). To prepare the matching fluids in Table 1, pipet the prescribed volumes of
the colorimetric test solutions (see Reagents, Indicators, and Solutions—Colorimetric Solutions) and water into one of the matching
containers and mix the solution in the container.

Table 1.▲ (USP 1-May-2021) Matching Fluids

Parts▲1
▲ (USP 1-May-2021) of Parts of Parts of
Matching Cobaltous Ferric Cupric Parts of
Fluid Chloride CS Chloride CS Sulfate CS Water
A 0.1 0.4 0.1 4.4

B 0.3 0.9 0.3 3.5

C 0.1 0.6 0.1 4.2

D 0.3 0.6 0.4 3.7

E 0.4 1.2 0.3 3.1

F 0.3 1.2 0.0 3.5

G 0.5 1.2 0.2 3.1

H 0.2 1.5 0.0 3.3

I 0.4 2.2 0.1 2.3

J 0.4 3.5 0.1 1.0

K 0.5 4.5 0.0 0.0

L 0.8 3.8 0.1 0.3

M 0.1 2.0 0.1 2.8

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Table 1.▲ (USP 1-May-2021) Matching Fluids (continued)

Parts▲1▲ (USP 1-May-2021) of Parts of Parts of
Matching Cobaltous Ferric Cupric Parts of
Fluid Chloride CS Chloride CS Sulfate CS Water
N 0.0 4.9 0.1 0.0

O 0.1 4.8 0.1 0.0

P 0.2 0.4 0.1 4.3

Q 0.2 0.3 0.1 4.4

R 0.3 0.4 0.2 4.1

S 0.2 0.1 0.0 4.7

T 0.5 0.5 0.4 3.6

1 The composition in Table 1 is described on a v/v basis and indicates the relative volume of each ingredient required to make the reference solution.

▲
If a matching fluid is prepared, it must be freshly prepared on the day of use unless suitable data demonstrating the stability
of the color in the matching fluid are available to support the use for longer time periods. For purchased color standards or
matching fluids, follow the appropriate use instructions and expiry dates.▲ (USP 1-May-2021)

Add the following:

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▲
METHOD I: ORGANOLEPTIC (QUALITATIVE) ASSESSMENT OF COLOR AND COLOR MATCHES

ci Illuminant
A standard illuminant is a theoretical source of visible light with a profile (its spectral power distribution) that is published.
Standard illuminants are designated by a letter or by a letter-number combination. Illuminants A, B, and C were introduced in
1931, with the intention of representing average incandescent light, direct sunlight, and average daylight, respectively. The
illumination of the sample(s) and matching fluid(s) should be solely due to the controlled illuminant source. Any additional
illumination from room lighting or windows should be minimized (for example, by use of a light box or light booth). A daylight
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illuminant capable of providing a correlated color temperature (CCT) of 6000–7000 K should be used. Filtered tungsten halogen
lamps are recommended, but daylight fluorescent lamps with comparable spectral and illuminance characteristics also can be
used. The spectral power distribution should conform to ISO 23603/CIE S 012 (4) for the D65 illuminant with a grade of B/C
or better. The illumination of the sample and matching fluid should be diffuse and not at an angle that will provide specular
reflections to the observer. Recommended geometries include 0:45 and 45:0 illuminant viewer, in degrees.
O

Observer
The observer angle may be normal (vertical) or at 90 degrees (horizontal) if the illumination angle is controlled to avoid
specular reflection and provides diffuse illumination relative to the observer angle. The sample and one or more matching fluids
should subtend a viewing angle of 2–10 degrees and be in the field of view simultaneously. Using identical tubes of colorless,
transparent, and neutral glass of 12-mm external diameter, compare 2.0 mL of the liquid to be examined with 2.0 mL of water
or matching fluid. A small, discernible gap should exist between the sample and matching fluid. The surrounding field should
be white, black, or neutral gray.

Procedures
Evaluate the sample and at least one other matching fluid simultaneously. Evaluate the brightness, saturation, and hue
(angle). Hue (angle) differences between the sample and the reference should be interpreted as a failure of the comparative
test unless there are explicit instructions in the monograph to ignore hue (angle) differences.
When analyzing samples that are expected to have color, there are three approaches:
1. Establish a minimum level of color. If the sample matches the reference sample or has more color, it passes the test.
2. Establish a maximum level of color. If the sample matches the reference sample or has less color, it passes.
3. Select a matching (or reference) solution to determine an indiscernible difference between the test sample and the
reference. In this case, the sample must match the matching solution. It is preferred, in this case, to establish a standard
of the same compound as the analyte of interest to avoid situations of metamerism.
Table 2 illustrates how the results of these color evaluations should be interpreted and reported.

Table 2. Interpretation of Color Comparisons for Qualitative Color Evaluations

Color Evaluation Test Test Requirement Sample Has More Color Reference Has More Color Sample Matches Reference
Compare sample to Purified
Almost Colorless Water. Fails the test Passes the test Passes the test

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Table 2. Interpretation of Color Comparisons for Qualitative Color Evaluations (continued)

Color Evaluation Test Test Requirement Sample Has More Color Reference Has More Color Sample Matches Reference
Compare to a matching fluid If used for achromicity, fails
that should exhibit discerni- the test. Otherwise, passes
Maximum Level of Color bly more color than sample. Fails the test Passes the test the test

Identify a matching fluid that

represents minimum accept-
Minimum Level of Color able color. Passes the test Fails the test Passes the test

Prepare color standard; com-

Indiscernible from Color pare test sample to color
Standard standard. Fails the test Fails the test Passes the test

Achromicity is a special case of an evaluation of the maximum level of color. For achromicity evaluations, one must either
perform an Indiscernible from Color Standard test using Purified Water as the standard or perform a Maximum Level of Color test
with a color standard with a low level of color that is discernibly different from Purified Water (i.e., a ΔE* relative to Purified
Water of 3–6). Matching fluids that are almost colorless are generally not useful for qualitative color evaluations and should be
avoided. Table 3 lists the matching fluids that should be avoided and those that are recommended for achromicity evaluations
using the Maximum Level of Color test.

Table 3. Matching Fluids for Use in Achromicity Evaluations (5)

Matching Fluids Darker and Differentiated from
Matching Fluids Almost Colorless (not recom- Colorless (recommended for maximum level of

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Source of Matching Fluid mended for use) color in an achromicity test)
This chapter None A, P, Q, S

European Pharmacopoeia,2.2.2. Degree of Coloration

of Liquids B7, B8, B9, BY7, Y7, GY7, R7
ci B6, BY5, Y5, GY5, R6

YG2, YG3, Y2, Y3, OY3, OY4, OR3, OR4, BR3, BR4,
Chinese Pharmacopoeia, Color Standard YG1, Y1, OY1, OR1, BR1 BR5

▲ (USP 1-May-2021)
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Add the following:
▲
METHOD II: INSTRUMENTAL (QUANTITATIVE) ASSESSMENT OF COLOR AND COLOR
MATCHES

Instrumentation
O

For evaluating the color of solutions, it is acceptable to use any spectrometer or colorimeter (in transmission mode) that has
been qualified for use, according to Ultraviolet–Visible Spectroscopy á857ñ, in the operating range of 400–700 nm and has a
bandwidth of 10 nm or less.

Calibration
For verification of the calibration in transmission mode, a black tile (or block of the light path) is used to determine the zero
end of the lightness scale; Purified Water (or relevant solvent) is used for 100% transmission (for more information, see Analytical
Instrument Qualification á1058ñ).

Recording of Spectroscopic Data

The spectroscopic data should be recorded from 400–700 nm at 10-nm intervals. If results are acquired at more frequent
intervals, only the results from the 10-nm intervals will be used to calculate the instrumental color values. If the samples are
turbid, they should be clarified by centrifugation or filtration prior to loading into the cuvette. Samples also should be checked
to ensure that the light transmission path is free from air bubbles or foam.

Calculation of CIELAB Values

This instrumental method relies on calculation of the color values in the CIELAB color space using either illuminant C with
the 2-degree observer or illuminant D65 with the 10-degree observer. Table 4 and Table 5 contain the weighting factors for
illuminant C with the 2-degree observer (C/2) and for illuminant D65 with the 10-degree observer (D65/10), respectively. These
weighting factors should be used to convert the spectroscopic data into CIELAB values (for additional information, see á1061ñ).
As an example, Table 6 contains three sets of spectroscopic transmittance data for the ideal Lovibond 10R, 10Y, and 10B glasses
(6). Table 7 shows the CIELAB (C/2) and CIELAB (D65/10) values calculated from these data using the weighting factors in
Table 4 and Table 5.

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Table 4. Weighting Factors for Illuminant C with 1931 (2-degree) Observer (400–700 nm, 10-nm spacing)a, b
λ (nm) Wx(λ) = xλPλ Wy(λ) = yλPλ Wz(λ) = zλPλ

400 0.099 0.003 0.463

410 0.325 0.009 1.547

420 1.292 0.038 6.207

430 2.968 0.123 14.496

440 3.959 0.261 19.860

450 3.931 0.443 20.728

460 3.360 0.692 19.286

470 2.283 1.061 15.022

480 1.116 1.612 9.479

490 0.363 2.358 5.286

500 0.048 3.414 2.868

510 0.092 4.842 1.512

520 0.578 6.449 0.720

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530 1.519 7.936 0.381

540 2.786 9.145 0.195

550 4.285 ci 9.831 0.086

560 5.877 9.834 0.038

570 7.323 9.148 0.020

580 8.414 7.990 0.015

590 8.985 6.629 0.010

ffi
600 8.958 5.321 0.007

610 8.324 4.177 0.003

620 7.055 3.146 0.001

630 5.327 2.196 0.000

O

640 3.692 1.442 0.000

650 2.352 0.887 0.000

660 1.360 0.503 0.000

670 0.713 0.261 0.000

680 0.364 0.132 0.000

690 0.172 0.062 0.000

700 0.154 0.055 0.000

Sum 98.074 100.000 118.230

White pointc 98.074 100.000 118.232

a Adapted from ASTM E308 (Standard Practice for Computing the Colors of Objects by Using the CIE System).
b The weighting factors (Wx, Wy, Wz) are obtained by multiplying the illuminant power at the particular wavelength (P) by the response factor at that wavelength
(x,y,z).
c The white point value is the exact value for the colorless/white standard. A slight difference may exist between the sum and white point values due to rounding
in the last decimal place.

Table 5. Weighting Factors for Illuminant D65 with 1964 (10-degree) Observer (400–700 nm, 10-nm spacing)a, b
λ (nm) Wx(λ) = xλPλ Wy(λ) = yλPλ Wz(λ) = zλPλ

400 0.145 0.015 0.643

410 0.676 0.069 3.110

420 1.603 0.168 7.627

430 2.451 0.300 12.095

440 3.418 0.554 17.537

450 3.699 0.890 19.888

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Table 5. Weighting Factors for Illuminant D65 with 1964 (10-degree) Observer (400–700 nm, 10-nm spacing)a, b (continued)
λ (nm) Wx(λ) = xλPλ Wy(λ) = yλPλ Wz(λ) = zλPλ

460 3.064 1.290 17.695

470 1.933 1.838 13.000

480 0.802 2.520 7.699

490 0.156 3.226 3.938

500 0.039 4.320 2.046

510 0.347 5.621 1.049

520 1.070 6.907 0.544

530 2.170 8.059 0.278

540 3.397 8.668 0.122

550 4.732 8.855 0.035

560 6.070 8.581 0.001

570 7.311 7.951 0.000

580 8.291 7.106 0.000

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590 8.634 6.004 0.000

600 8.672 5.079 0.000

610 7.930 4.065 0.000

620 6.446 ci 2.999 0.000

630 4.669 2.042 0.000

640 3.095 1.290 0.000

650 1.859 0.746 0.000

660 1.056 0.417 0.000

ffi
670 0.570 0.223 0.000

680 0.274 0.107 0.000

690 0.121 0.047 0.000

700 0.109 0.043 0.000

O

Sum 98.809 100.000 107.307

White point 98.811 100.000 107.304

a Adapted from ASTM E308 (Standard Practice for Computing the Colors of Objects by Using the CIE System).
b The weighting factors (Wx, Wy, Wz) are obtained by multiplying the illuminant power at the particular wavelength (P) by the response factor at that wavelength
(x,y,z).

Table 6. Ideal Lovibond Transmission Spectra for 10R, 10Y, and 10B plates (6)
λ (nm) 10R 10Y 10B
400 0.3368 0.0000 0.9007

410 0.3429 0.0001 0.8938

420 0.3480 0.0013 0.8815

430 0.3514 0.0073 0.8630

440 0.3538 0.0271 0.8414

450 0.3527 0.0750 0.8154

460 0.3475 0.1704 0.7780

470 0.3370 0.3024 0.7112

480 0.3144 0.4441 0.6119

490 0.2753 0.5671 0.5013

500 0.2164 0.6615 0.4136

510 0.1472 0.7319 0.3172

520 0.0939 0.7801 0.2373

530 0.0709 0.8116 0.1722

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Table 6. Ideal Lovibond Transmission Spectra for 10R, 10Y, and 10B plates (6) (continued)
λ (nm) 10R 10Y 10B
540 0.0866 0.8354 0.1525

550 0.1483 0.8486 0.1822

560 0.2509 0.8521 0.2231

570 0.3703 0.8530 0.1967

580 0.4763 0.8472 0.1235

590 0.5666 0.8382 0.0674

600 0.6351 0.8264 0.0631

610 0.6861 0.8127 0.0712

620 0.7251 0.7989 0.0750

630 0.7558 0.7860 0.0709

640 0.7788 0.7776 0.0601

650 0.7968 0.7740 0.0645

660 0.8115 0.7734 0.0786

al
670 0.8230 0.7774 0.1457

680 0.8330 0.7834 0.2734

690 0.8419 0.7869 0.4701

700 0.8485 ci 0.7918 0.6607

Table 7. CIELAB Values Calculated from the Data in Table 6 and Using the Weighting Factors from Table 4 and Table 5
Calculation with Illuminant C and 1931 (2-degree) Observer Calculation with Illuminant D65 and 1964 (10-degree) Observer

CIELAB Values 10R 10Y 10B 10R 10Y 10B

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L* 64.32 91.20 51.83 63.67 90.02 54.75

a* 49.79 –21.97 23.36 47.75 –15.48 9.65

b* –0.27 71.64 –65.31 –1.77 73.38 –61.29

C*ab 49.79 74.93 69.37 47.79 75.00 62.05

O

h*ab 359.69 107.05 269.68 357.88 101.91 278.95

METHOD IIA: COMPARATIVE TEST OF COLORS USING CIELAB VALUES

The CIELAB values for a sample and a matching solution may be evaluated to determine the acceptability of the sample.
Table 8 lists the different metrics that may be used to compare the color values of a sample to the color values of a matching
solution. In evaluating stability, the color values may be tracked over time to assess trends. The variability in the color values
may be used to assess process control and variability due to raw materials or processing.

Table 8. Interpretation of Color Comparisonsa, b

Color Evaluation Test Test Requirement
Measure the sample and Purified Water. Calculate
ΔE* relative to Purified Water. Requirement is that
Almost Colorless Compare the sample to Purified Water. ΔE* < 1.

Measure the matching fluid and calculate the ΔE0*

Identify a matching fluid of similar hue angle (Δh*ab relative to Purified Water. Measure the sample and
< 15) that is discernibly more colored than the sam- calculate the ΔE* relative to Purified Water. Require-
Maximum Level of Color ple. ment is ΔE* < ΔE0*.

Measure the matching fluid and calculate the ΔE0*

Identify a matching fluid of similar hue angle (Δh*ab relative to Purified Water. Measure the sample and
< 15) that is discernibly less colored than the sam- calculate the ΔE* relative to Purified Water. Require-
Minimum Level of Color ple. ment is ΔE* > ΔE0*.

Prepare color standard; compare the test sample to Calculate ΔE* relative to selected color standard. Re-
Indiscernible from Color Standard the color standard. quirement is that ΔE* < 3.

a Comparisons rely on the numerical values of L*, a*, and b*, and the comparison of these values to those of the matching solution or standard.
b CIELAB values must be calculated with the same illuminant and observer for evaluating differences between the sample and matching fluid.

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Printed by: Dang Van Vu Official Date: Official as of 01-May-2021 Document Type: GENERAL CHAPTER @2023 USPC
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METHOD IIB: INSTRUMENTAL COLOR ASSESSMENT

The CIELAB values (calculated as described in Method IIa: Comparative Testing of Colors Using CIELAB Values) may be used
directly as a quantitative measure of the color attributes of a sample. Acceptable specifications for the color attributes can be
established in the CIELAB color space and applied to color values obtained for a sample.
For new monographs under development, which do not already have a visual color determination method, the following
approach harnesses the advantages of instrumental colorimetry to its fullest and removes drawbacks associated with limiting
the control space to what is encompassed by existing visual standards. Also, for new monographs under development,
acceptable numerical limits within color space should be determined based on process capability, stability, and analytical
variability. A specification would then take the form of one of the following:
• A solution with L* NLT XX, NMT XX; a* NMT XX, NLT XX; and b* NMT XX, NLT XX (XX being a numerical value).
• ΔE* versus a single point in 3-dimensional space. Ideally this point would represent the average based on multiple batches
or based on representative material, such as a well-characterized reference standard. Other points may be justified.
Limits may be set with individual color parameters (e.g., L*, a*, and b* or another suitably validated color space) or as a ΔE*
versus a single point in color space when considering batch release or stability studies.

Reporting of Results
The calculated CIELAB color values are dependent on the illuminant and observer used and, therefore, should be reported.
The CIELAB values for the coordinates L*, a*, and b* should be reported. The values for chroma (C*ab) and hue angle (h*ab) are
derived from a* and b* and do not need to be reported. A recommended method for reporting the CIELAB results is to report

al
the color values as shown in the following examples:

CIELAB ([illuminant]/[observer]) = (L*, a*, b*)

CIELAB (C/2) = (50.70, −11.30, −33.30)
CIELAB (D65/10) = (52.69, −19.43, 29.61)▲ (USP 1-May-2021)
ci
Add the following:
▲
REFERENCES

1. Pack BW, Montgomery LL, Hetrick E. Modernization of physical appearance and solution color tests using quantitative
ffi
tristimulus colorimetry: advantages, harmonization, and validation strategies. J Pharm Sci. 2015;104:3299–3313.
2. European Pharmacopoeia (Ph.Eur.). 2.2.2. Degree of Coloration of Liquids. In: Ph.Eur. 9.5. 2018;22–24.
3. Chinese Pharmacopoeia (Ch.P.). Appendix XI.A. Colour of Solution. In: Ch.P. 2010;A79–A81.
4. International Commission on Illumination. ISO/CIE Publication ISO 23603/CIE S012 (previously designated as CIE
Publication 51.2). Standard method for assessing the spectral quality of daylight for visual appraisal and measurement
O

of color. 2004.
5. ASTM International. ASTM E308-18. Standard practice for computing the colors of objects by using the CIE system. West
Conshohocken, PA: ASTM International; 2017.
6. Judd DB, Chamberlin GJ, Haupt GW. The ideal Lovibond color system. J Res NIST. 1962;66C(2):121–136.
▲ (USP 1-May-2021)

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