Certificate

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

1222818
F161Y0

Valid Use Date

14-NOV-2024

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 the
media 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

Copyright 2018 The United States Pharmacopeial Convention. All rights reserved.

USP Certificate
USP Template No.: CERT1-07
Template Effective Date: August 31, 2021

Page 1 of 6

Dissolution <711>
Procedure:

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

Single-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 pointspecified. 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)

681-92

4.6

781-92

4.5

882-92

4.4

1281-92

4.5

1481-924.5

646-596.2

746-596.1

846-596.0

1246-59

6.1

1446-59

6.0

2 (Paddle)

Copyright 2018 The United States Pharmacopeial Convention. All rights reserved.

USP Certificate
USP Template No.: CERT1-07
Template Effective Date: August 31, 2021

Page 2 of 6

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%CV

683-90

3.4

81-92

4.5

783-90

3.4

81-92

4.4

883-90

3.4

82-92

4.3

648-57

4.6

46-59

6.1

748-57

4.6

46-59

6.0

848-57

4.6

46-59

5.9

Copyright 2018 The United States Pharmacopeial Convention. All rights reserved.

USP Certificate
USP Template No.: CERT1-07Template Effective Date: August 31, 2021

Page 3 of 6

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 any
adjustments 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

66.4
8.6

1
2

Number of Vessels
76.2
8.5

8
6.1
8.4

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 2018 The United States Pharmacopeial Convention. All rights reserved.

USP Certificate
USP Template No.: CERT1-07
Template Effective Date: August 31, 2021

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LABEL TEXT_____________________________________________
Quality Assurance

Certificate Version History
Version NumberDate

Reasons for Change

00

17-JAN-2023

First issue

01 (Current)

25-APR-2023

Removed PF 48(2) in the Uses section as <711> containing the USP Dissolution
Performance Verification Standard – Prednisone RS is official as of 01-MAY-2023.
Added USP PVT calculation tool weblink above the Calculation Example on page 4.

Copyright 2018 The United States Pharmacopeial Convention. All rights reserved.

USP Certificate
USP Template No.: CERT1-07
Template Effective Date: August 31, 2021

Page 5 of 6

Assigned Value

Please refer to the USP Reference Standard label and/or USP Certificate for the assigned value of the specific lot. If anassigned value is not included on the label or Certificate, the lot was developed for qualitative USP compendial use
and an assigned value will not be provided.
Valid Use Date

It is the responsibility of the user to ascertain that a particular lot of a USP Reference Standard has official status
either as a "Current Lot" or as a "Previous Lot" within the assigned valid use date. The online USP ReferenceStandards Catalog and the online USP Store at www.usp.org are updated daily. USP recommends referring to one ofthese sources prior to using a USP RS to make sure the lot is valid for use.
Storage

Storage conditions are lot–specific and may change from one lot to another. The storage condition for an unopened
USP Reference Standard is provided on the container label only, not on the Safety Data Sheet. If no specificdirections or limitations are on the label, conditions of storage include storage at room temperature and protection
from moisture, light, freezing, and excessive heat. See General Chapter <659> in the USP-NF Online for storage andhandling definitions.
Instructions for Use

Follow the instructions provided on this Certificate, on the label of the USP Reference Standard, and in theassociated
USP documentary standard(s). Please refer to General Chapter <11> for additional information.
Non-USP Compendial Use

USP Reference Standards are intended only for use in analytical or laboratory applications generally as specified in
USP compendia. They are not for use in humans or animals as drugs or medical devices. It may be possible to use aUSP RS outside of its associated USP compendial applications; however, it is the responsibility of the user todetermine the suitability of the USP RS for a non-USP use.
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USP WARRANTS GOOD TITLE TO USP REFERENCE STANDARDS ON DISPATCH FROM USP. THE FOREGOINGWARRANTY IS IN LIEU OF ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANYWARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR ANY WARRANTY THAT THEPRODUCTS, INCLUDING THIS CERTIFICATE, ARE OF MERCHANTABLE QUALITY. USP’S LIABILITY ARISING OUT OF ORRELATING TO THE SUPPLY OF USP REFERENCE STANDARDS AND THIS CERTIFICATE SHALL IN NO EVENT INCLUDELOSS OF PROFITS, COST OF PROCURING SUBSTITUTE GOODS OR SERVICES, OR ANY INCIDENTAL, INDIRECT, ORCONSEQUENTIAL DAMAGES OF ANY KIND, EVEN IF USP IS AWARE OF THE POSSIBILITY OF SUCH DAMAGES.
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USP Reference Standards are not intended for use as drugs, dietary supplements, or as medical devices.
This certificate may not be reproduced without the express written permission of USP.

Copyright 2018 The United States Pharmacopeial Convention. All rights reserved.

USP Certificate
USP Template No.: CERT1-07
Template Effective Date: August 31, 2021

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