29/4/25, 3:51 p.m.

USP-NF 〈905〉 Uniformity of Dosage Units

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Status: Currently Official on 29-Apr-2025
Official Date: Official as of 01-Aug-2023
Document Type: General Chapter
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DOI Ref: fdg70
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〈905〉 UNIFORMITY OF DOSAGE UNITS

Change to read:
This general chapter is harmonized with the corresponding texts of the European Pharmacopoeia and the Japanese Pharmacopoeia.

Portions of the general chapter text that are national USP text, and are not part of the harmonized text, are marked with symbols (⧫⧫) to

specify this fact.

[Note—In this chapter, unit and dosage unit are synonymous.⧫]

To ensure the consistency of dosage units, each unit in a batch should have a drug substance content within a narrow range around the
label claim. Dosage units are defined as dosage forms containing a single dose or a part of a dose of drug substance in each unit. The

uniformity of dosage units specification is not intended to apply to ▲solutions,▲ (USP 1-Aug-2023) suspensions, emulsions, or gels in unit-dose

containers intended for ▲local action following▲ (USP 1-Aug-2023) external, cutaneous administration.

The term “uniformity of dosage unit” is defined as the degree of uniformity in the amount of the drug substance among dosage units.
Therefore, the requirements of this chapter apply to each drug substance being comprised in dosage units containing one or more drug

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substances, unless otherwise specified elsewhere in this Pharmacopeia.

The uniformity of dosage units can be demonstrated by either of two methods, Content Uniformity or ⧫Weight Variation (see Table 1). The
⧫
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test for Content Uniformity of preparations presented in dosage units is based on the assay of the individual content of drug substance(s) in
a number of dosage units to determine whether the individual content is within the limits set. The Content Uniformity method may be applied
in all cases.

The test for ⧫Weight⧫Variation is applicable for the following dosage forms:
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(W1) Solutions enclosed in unit-dose containers and into soft capsules;

Solids (including powders, granules, and sterile solids) that are

(W2) packaged in single-unit containers and contain no active or inactive
FF

added substances;

Solids (including sterile solids) that are packaged in single-unit

containers, with or without active or inactive added substances,
(W3) that have been prepared from true solutions and freeze-dried in the
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final containers and are labeled to indicate this method of prepara-

tion; and

Hard capsules, uncoated tablets, or film-coated tablets, containing

25 mg or more of a drug substance comprising 25% or more, by
weight, of the dosage unit or, in the case of hard capsules, the cap-
(W4)
sule contents, except that uniformity of other drug substances
present in lesser proportions is demonstrated by meeting the re-
quirements for Content Uniformity.

The test for Content Uniformity is required for all dosage forms not meeting the above conditions for the ⧫Weight⧫Variation test.1

Table 1. Application of Content Uniformity (CU) and Weight Variation (WV) Tests for Dosage Forms

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 29/4/25, 3:51 p.m. USP-NF 〈905〉 Uniformity of Dosage Units

Dose & Ratio of

Drug Substance
Type Subtype

Dosage Form ≥25 mg and ≥25% <25 mg or <25%

Uncoated — WV CU

Film WV CU

Tablets Coated Others CU CU

Hard — WV CU

Suspension, emulsion,
or gel CU CU

Capsules Soft Solutions WV WV

Single component — WV WV

Solution freeze-dried in
final
container WV WV
Solids in
single-unit containers Multiple components Others CU CU

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Solutions in unit-dose

containers ⧫and into soft — —

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capsules⧫ WV WV

Others▲a▲ (USP 1-Aug-

— —
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2023) CU CU

a
Dosage forms not addressed by the other categories in this table including but not limited to suppositories, transdermal systems
(patches), and semisolid preparations applied cutanenously and intended for systemic distribution of the drug substance.

CONTENT UNIFORMITY
FF

Select not fewer than 30 units, and proceed as follows for the dosage form designated.
Where different procedures are used for assay of the preparation and for the Content Uniformity test, it may be necessary to establish a
correction factor to be applied to the results of the latter.

Solid Dosage Forms

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Assay 10 units individually using an appropriate analytical method. Calculate the acceptance value (see Table 2).

Liquid or Semi-Solid Dosage Forms

Assay 10 units individually using an appropriate analytical method. Carry out the assay on the amount of well-mixed material that is
removed from an individual container in conditions of normal use, and express the results as delivered dose. Calculate the acceptance value
(see Table 2).

Calculation of Acceptance Value

Calculate the acceptance value by the formula:

¯
M − X + ks

in which the terms are as defined in Table 2.

Table 2

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 29/4/25, 3:51 p.m. USP-NF 〈905〉 Uniformity of Dosage Units

Variable Definition Conditions Value

Mean of individual contents (χ1,

χ2, …, χn), expressed as a per- — —

X centage of the label claim

Individual contents of the units

tested, expressed as a percent- — —
χ1, χ2, …, χn age of the label claim

Sample size (number of units in

— —
n a sample)

If n = 10, then k = 2.4

k Acceptability constant If n = 30, then k = 2.0

1
n 2 2
¯
Σ ( i −X)
— χ
i=1
[ ]
n−1
s Sample standard deviation

Relative standard deviation (the

sample standard deviation ex-
— 100s/X
pressed as a percentage of the

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RSD mean)
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If 98.5% ≤X ≤101.5%, then M = X (AV = ks)

M = 98.5%
If X <98.5%, then
(AV = 98.5 – X + ks)
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M (case 1) to be applied when M = 101.5%

If X >101.5%, then
T ≤101.5 Reference value (AV = X – 101.5 + ks)

M=X
If 98.5 ≤X ≤T, then
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(AV = ks)

M = 98.5%
If X <98.5%, then
(AV = 98.5 – X + ks)

M (case 2) to be applied when M = T%

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If X >T, then
T >101.5 Reference value (AV = X – T + ks)

General formula:

¯
M − X + ks
— —
(Calculations are specified
above for the different
Acceptance value (AV) cases.)

Maximum allowed acceptance L1 = 15.0 unless otherwise

—
L1 value specified

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29/4/25, 3:51 p.m. USP-NF 〈905〉 Uniformity of Dosage Units

Variable Definition Conditions Value

On the low side, no dosage unit

result can be less than [1–
(0.01)(L2)]M, while on the high
L2 = 25.0 unless otherwise
Maximum allowed range for de- side, no dosage unit result can
specified
viation of each dosage unit be greater than [1 + (0.01)
tested from the calculated (L2)]M. (This is based on an L2
L2 value of M value of 25.0.)

Target content per dosage unit

at the time of manufacture, ex-
pressed as a percentage of the
label claim. Unless otherwise — —
stated, T is 100.0%, or T is the
manufacturer's approved target
T content per dosage unit.

⧫WEIGHT VARIATION
⧫

Carry out an assay for the drug substance(s) on a representative sample of the batch using an appropriate analytical method. This value is
result A, expressed as percentage of label claim (see Calculation of Acceptance Value). Assume that the concentration (weight of drug
substance per weight of dosage unit) is uniform. Select not fewer than 30 dosage units, and proceed as follows for the dosage form
designated.

Uncoated or Film-Coated Tablets

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Accurately weigh 10 tablets individually. Calculate the content, expressed as percentage of label claim, of each tablet from the ⧫weight of
⧫
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the individual tablet and the result of the Assay. Calculate the acceptance value.

Hard Capsules

Accurately weigh 10 capsules individually, taking care to preserve the identity of each capsule. Remove the contents of each capsule by a

suitable means. Accurately weigh the emptied shells individually, and calculate for each capsule the net ⧫weight⧫ of its contents by
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subtracting the ⧫weight⧫ of the shell from the respective gross ⧫weight⧫. Calculate the drug substance content of each capsule from the ⧫net

weight⧫ of the individual capsule ⧫content⧫ and the result of the Assay. Calculate the acceptance value.

Soft Capsules
FF

Accurately weigh 10 intact capsules individually to obtain their gross ⧫weights⧫, taking care to preserve the identity of each capsule. Then

cut open the capsules by means of a suitable clean, dry cutting instrument such as scissors or a sharp open blade, and remove the contents
by washing with a suitable solvent. Allow the occluded solvent to evaporate from the shells at room temperature over a period of about 30
minutes, taking precautions to avoid uptake or loss of moisture. Weigh the individual shells, and calculate the net contents. Calculate the
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drug substance content in each capsule from the ⧫weight⧫ of product removed from the individual capsules and the result of the Assay.

Calculate the acceptance value.

Solid Dosage Forms Other Than Tablets and Capsules

Proceed as directed for Hard Capsules, treating each unit as described therein. Calculate the acceptance value.

Liquid Dosage Forms

Accurately weigh the amount of liquid that is removed from each of 10 individual containers in conditions of normal use. If necessary,
compute the equivalent volume after determining the density. Calculate the drug substance content in each container from the mass of
product removed from the individual containers and the result of the Assay. Calculate the acceptance value.

Calculation of Acceptance Value

Calculate the acceptance value as shown in Content Uniformity, except that the individual contents of the units are replaced with the
individual estimated contents defined below.

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29/4/25, 3:51 p.m. USP-NF 〈905〉 Uniformity of Dosage Units

χ1, χ2, …, χn = individual estimated contents of the units tested, where χi = wi × A/W

w1, w2, …, wn = individual ⧫weights⧫ of the units tested

A = content of drug substance (% of label claim) obtained using an appropriate analytical method

W = mean of individual ⧫weights⧫ (w1, w2, …, wn)

CRITERIA
Apply the following criteria, unless otherwise specified.

Solid, Semi-Solid, and Liquid Dosage Forms

The requirements for dosage uniformity are met if the acceptance value of the first 10 dosage units is less than or equal to L1%. If the
acceptance value is > L1%, test the next 20 units, and calculate the acceptance value. The requirements are met if the final acceptance value

of the 30 dosage units is ≤ L1%, and no individual content of ⧫any⧫ dosage unit is less than [1 − (0.01)(L2)]M nor more than [1 + (0.01)(L2)]M

⧫as specified in the Calculation of Acceptance Value under Content Uniformity or under ⧫Weight Variation. Unless otherwise specified, L1 is
⧫ ⧫

15.0 and L2 is 25.0.

1 ⧫European Pharmacopoeia and Japanese Pharmacopoeia text not accepted by the United States Pharmacopeia: Alternatively, products

listed in item (4) above that do not meet the 25 mg/25% threshold limit may be tested for uniformity of dosage units by Mass Variation instead
of the Content Uniformity test if the concentration relative standard deviation (RSD) of the drug substance in the final dosage units is not more
than 2%, based on process validation data and development data, and if there has been regulatory approval of such a change. The

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concentration RSD is the RSD of the concentration per dosage unit (w/w or w/v), where concentration per dosage unit equals the assay result
per dosage unit divided by the individual dosage unit weight. See the RSD formula in Table 2.⧫
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Auxiliary Information - Please check for your question in the FAQs before contacting USP.

Topic/Question Contact Expert Committee

Ravi Dasari GCDF2020 General Chapters - Dosage Forms

IC

<905> UNIFORMITY OF DOSAGE UNITS

Statistician 2020

RS Technical Services GCDF2020 General Chapters - Dosage Forms

REFERENCE STANDARD SUPPORT
[email protected] 2020
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Most Recently Appeared In:

Pharmacopeial Forum: Volume No. PF 35(3)

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DOI: https://doi.org/10.31003/USPNF_M99694_03_01
DOI ref: fdg70

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