USP REFERENCE STANDARD CERTIFICATEDISSOLUTION PERFORMANCE VERIFICATION STANDARD - PREDNISONE(10 mg nominal prednisone content per tablet)
USP Catalog No.:
USP Lot No.:

1222818
R182R0

Valid Use Date

31-JUL-2025

Storage/Handling

As per the label.

Uses

General Chapter <711> Dissolution, Performance Verification Test (PVT), Apparatus 1 andApparatus 2

Dissolution <711>
Medium:499 g of degassed purified water maintained at 37° ± 0.5°

Medium degassing:Recommended degassing procedure: Heat a suitable amount of water, while stirring
gently to about 41-45°. Filter under vacuum through a 0.45-μm-porosity filter into asuitable filtering flask equipped with a stirring device. Seal the flask and continue toapply vacuum while stirring for an additional five minutes. Measured vacuum should beless than 100 mbar.
Note: Other validated degassing methods that reduce the total dissolved gas in themedia can also be used

Apparatus:

Apparatus 1 (Basket) or Apparatus 2 (Paddle) at 50 RPM
Note: If equipment is dedicated for use with only one apparatus (basket or paddle),then performance verification is only required for that apparatusTime:

30 minutes

Standard Solution:

A known concentration of USP Prednisone RS in Medium.
Note: An amount of alcohol not to exceed 5% of the total volume of the standard
solution may be used to bring the prednisone reference standard into solution.

Sample solution:

Laboratory can choose either Single-Stage Test or Optional Two-Stage Test scheme toobtain Sample Solutions.
A filtered portion of the solution under test, suitably diluted, if necessary, with Medium
to obtain a concentration similar to that of the Standard solution.
Note 1: The filtering method must not cause adsorptive loss of drug
Note 2: Bias introduced by automated methods is to be avoided

Analysis:

UV at maximum absorbance of about 242 nm

Procedure:

Determine the quantity of prednisone, C21H26O5, dissolved at 30 minutes in each vessel
expressed as percent of the labeled amount.

Copyright 2023 The United States Pharmacopeial Convention. All rights reserved.
USP Reference Standard Certificate Template No.: FORM-00008-02
Template Effective Date: 15-DEC-2023

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USP REFERENCE STANDARD CERTIFICATESingle-Stage Test Instructions and Acceptance Criteria
1.

For each position in the assembly, test one USP Dissolution Performance Verification Standard –Prednisone (DPVS – Prednisone) RS tablet, and record the percent dissolved at the sampling time point
specified. Transform the percent dissolved results to the natural log scale, determine the mean andvariance. For assemblies with 12 or 14 dissolution vessels, no further testing is required2.

For assemblies with fewer than 12 positions, repeat Step 1 with an additional set of tablets. Transformthe percent dissolved results to the natural log scale, determine the mean and variance.

3.

Calculate the average of the two means and of the two variances obtained in Steps 1 and 2.
Use the results from Step 1 alone for assemblies that have 12 or 14 positions.

4.

Convert the results of Step 3 to a geometric mean (GM) and percent coefficient of variation (%CV). See
Calculation Example for details.

5.

Compare the results of Step 4 to the Single-Stage acceptance criteria in Table 1. The GM must not falloutside the limits, and the %CV must not be greater than the limit. If both meet the criteria, the assembly
has passed the PVTTable 1. Performance Verification Test Acceptance Criteria for Single-Stage TestApparatus

No. of vessels per run

Geometric Mean, %Prednisone Dissolved%CV1 (Basket)

681-944.4

781-944.3

881-944.2

1281-944.3

1481-94

4.3

645-57

5.4

745-57

5.3

845-56

5.21245-57

5.4

1445-57

5.3

2 (Paddle)

Copyright 2023 The United States Pharmacopeial Convention. All rights reserved.
USP Reference Standard Certificate Template No.: FORM-00008-02
Template Effective Date: 15-DEC-2023

Page 2 of 6

USP REFERENCE STANDARD CERTIFICATE
Optional Two-Stage Test Instructions and Acceptance Criteria
A laboratory may choose to implement the PVT as a Two-Stage test in case of assemblies with less than 12positions. The Two-Stage test is a statistically valid means of allowing the possibility of stopping the test at thefirst stage using more stringent acceptance criteria. The following are step-by-step instructions for the twostage test
1.

For each position in the assembly, test one USP DPVS – Prednisone RS tablet, and record the percent
dissolved at the sampling time point specified. Transform the percent dissolved results to the natural log
scale, determine the mean and variance2.

Convert the results of Step 1 to a GM and %CV and compare to the 1st Stage of Two Stages acceptance
ranges in Table 2. The GM must not fall outside the limits, and the %CV must not be greater than thelimit. For calculation of the GM and %CV, see Calculation Example for details

3.

If results of Step 2 satisfy both acceptance criteria, the assembly has passed the PVT. Otherwise continue
to Step 4. Prior to proceeding to Step 4, see Futility Factor section.

4.

Repeat Step 1 with an additional set of tablets. Transform the percent dissolved results to the natural log
scale determine the mean and variance for the data obtained at this step

5.

Average the two means and two variances obtained in Steps 1 and 4

6.

Convert the results of Step 5 to a geometric mean (GM) and percent coefficient of variation (%CV). For
calculation of the GM and %CV, see Calculation Example for details

7.

Compare the results of Step 6 to the 2nd Stage of Two Stages acceptance ranges in Table 2. The GM must
not fall outside the limits, and the %CV must not be greater than the limit. If both meet the acceptancecriteria, the assembly has passed the PVTTable 2. Performance Verification Test Acceptance Criteria for Two-Stage Test
Apparatus

1 (Basket)

2 (Paddle)

First Stage of Two-Stage Test

Second Stage of Two-Stage Test

No. ofvessels
per runGeometric Mean, %Prednisone Dissolved%CV

Geometric Mean, %Prednisone Dissolved

%CV6

83-91

3.3

81-94

4.4

783-91

3.3

81-94

4.3

883-91

3.3

81-94

4.2

647-54

4.1

45-57

5.4

747-54

4.1

45-57

5.3

847-54

4.1

45-56

5.2

Copyright 2023 The United States Pharmacopeial Convention. All rights reserved.
USP Reference Standard Certificate Template No.: FORM-00008-02
Template Effective Date: 15-DEC-2023

Page 3 of 6

USP REFERENCE STANDARD CERTIFICATE
Futility Factor
If optional Stage-Two test is chosen, there are circumstances when the %CV after the First Stage of Two-Stage test equals
or exceeds the value in the Futility Factor table (without rounding). In such cases it is impossible to meet the %CV
criterion after the Second Stage of the Two-Stage test. The lab can stop after the First Stage run. However, after anyadjustments to equipment, test procedure, and so on, the PVT must be restarted with a new first run (Step 1 of the twostage test instructions).
Futility Factor, %CV at or above value given, second stage testing will not produce passing result
Apparatus

66.2
7.6

1
2

Number of Vessels
76.1
7.5

8
5.9
7.4

Refer to this website for the USP Calculation Tool: https://apps.usp.org/app/USPNF/pvtCalculationTool/
Calculation Example (expressed as Microsoft Excel worksheet functions):
Run 1: x1, x2, ..., xn in natural log scale: Ln x1, Ln x2, …, Ln xn
Run 2: xn+1, xn+2, ..., x2n in natural log scale: Ln xn+1, Ln xn+2, …, Ln x2n
1st Stage of Two-Stage for n=6, 7, 8 and Single-Stage for n=12, 14:
GM1 = exp(average (Ln x1:Ln xn))
%CV1 = 100*sqrt(exp(var(Ln x1:Ln xn)) -1)
Single-Stage or 2nd Stage of Two-Stage for n= 6, 7, 8:
GM = exp(average((average (Ln x1:Ln xn)), (average (Ln xn+1:Ln x2n)))) = exp(average (Ln x1:Ln x2n))%CV= 100*sqrt(exp(average((var(Ln x1:Ln xn)),(var(Ln xn+1:Ln x2n)))) -1)
exp: exponential (ex)var: variancesqrt: square root*: multiply

100: conversion factor to percentage

For more information and guidelines about how to complete the performance verification test refer to thefollowing website: https://www.usp.org/small-molecules/pvt

Copyright 2023 The United States Pharmacopeial Convention. All rights reserved.
USP Reference Standard Certificate Template No.: FORM-00008-02
Template Effective Date: 15-DEC-2023

Page 4 of 6

USP REFERENCE STANDARD CERTIFICATE
Label

Quality Assurance

Certificate Version History
Version Number

Date

Reasons for Change

00 (Current)

14-MAR-2024

First issue

Copyright 2023 The United States Pharmacopeial Convention. All rights reserved.
USP Reference Standard Certificate Template No.: FORM-00008-02
Template Effective Date: 15-DEC-2023

Page 5 of 6

USP REFERENCE STANDARD CERTIFICATE

Copyright 2023 The United States Pharmacopeial Convention. All rights reserved.
USP Reference Standard Certificate Template No.: FORM-00008-02
Template Effective Date: 15-DEC-2023

Page 6 of 6