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ASTM E2503-13e1

(Practice)

Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus

Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus

SIGNIFICANCE AND USE
2.1 This practice outlines a procedure for the mechanical calibration of paddle and basket dissolution units to ensure reproducibility of results.  
2.2 Once a unit meets all of the mechanical specifications included in this practice, it is considered calibrated and further calibration with dissolution calibrator tablets is not required.
SCOPE
1.1 This practice covers the set-up and calibration of the paddle and basket dissolution apparatus.  
1.2 Use of this practice may be applied to apparatus that have been modified to enable automatic dissolution testing (that is, a valve in the bottom of the vessel or sampling through the shaft).  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
31-Jan-2013
ICS
11.120.99 - Other standards related to pharmaceutics
Technical Committee
E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
Drafting Committee
E55.03 - General Pharmaceutical Standards
Current Stage
Ref Project

Relations

Replaces
ASTM E2503-13 - Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus
Effective Date
01-Feb-2013

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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
´1
Designation:E2503 −13
Standard Practice for
1
Qualification of Basket and Paddle Dissolution Apparatus
This standard is issued under the fixed designation E2503; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1
ε NOTE—Editorial corrections made throughout in April 2015.
1. Scope 4.2 Wherever possible, tools shall be traceable to an ac-
cepted standard calibration source from a national or interna-
1.1 This practice covers the set-up and calibration of the
tional calibration laboratory.
paddle and basket dissolution apparatus.
4.3 ApparatusSet-up—Duringapparatusinstallationorafter
1.2 Use of this practice may be applied to apparatus that
replacement of parts or components, verify that the description
have been modified to enable automatic dissolution testing
(that is, a valve in the bottom of the vessel or sampling through and critical dimensions for each part meets the original
the shaft). description and dimension.
4.3.1 VesselDimensions—In the absence of a COAor COC,
1.3 The values stated in SI units are to be regarded as
the vessel’s internal dimensions should be measured with an
standard. No other units of measurement are included in this
appropriate measuring device and vessel shape and condition
standard.
should be noted. For example, for a cylindrical, hemispherical
1.4 This standard does not purport to address all of the
vessel, the vessel’s sides must be cylindrical, the internal
safety concerns, if any, associated with its use. It is the
dimension should be measured, and the vessel bottom should
responsibility of the user of this standard to establish appro-
be smooth and without defects. The vessel must fit within the
priate safety and health practices and determine the applica-
apparatus in such a manner as to ensure stable operation and
bility of regulatory limitations prior to use.
centering of the shaft in the vessel.
2. Significance and Use
4.3.2 Basket/ShaftDimensions—In the absence of a COAor
2.1 This practice outlines a procedure for the mechanical
COC, an appropriate measuring device is used to measure the
calibration of paddle and basket dissolution units to ensure
relevant basket dimensions. Critical dimensions to be mea-
reproducibility of results.
suredoneachbasketshouldincludebutarenotlimitedto:shaft
diameter, vent hole diameter, thickness of wide portion of the
2.2 Once a unit meets all of the mechanical specifications
basket-to-shaft adaptor, total basket height, internal diameter at
included in this practice, it is considered calibrated and further
the top of the basket, outer diameter of the screen, height of the
calibration with dissolution calibrator tablets is not required.
open screen, outer diameter of bottom, diameter of screen on
3. Analyst Responsibilities
the bottom, and screen mesh number.
3.1 Verify the vessel, basket, and paddle dimensions on
4.3.3 Paddle Dimensions—In the absence of a COA or
receipt through measurement or Certificate ofAnalysis (COA)
COC, an appropriate measuring device is used to measure the
or Certificate of Conformity (COC).
relevant dimensions of the paddle. Examples of dimensions to
3.2 Ensure the instrument is calibrated and fit for perform- be determined on each paddle should include but are not
ing dissolution analysis. limited to: shaft diameter, blade height, blade thickness, total
blade length, length of flat portion on bottom of blade, radius
4. Procedure
oftheangleonthetopouteredgeofthetopoftheblade,radius
4.1 Background—The set-up, mechanical, and operational
of the outside edge of the blade, difference between the
checks are used to minimize variability during dissolution
distance from the midline of the shaft to the top outer edge for
testing to ensure the reproducibility of dissolution results.
the two sides, and difference between the heights of both sides
of the paddles at the outside top.
1
This practice is under the jurisdiction of ASTM Committee E55 on Manufac-
ture of Pharmaceutical and Biopharmaceutical Products and is the direct responsi-
4.4 Maintenance—Consult the manufacturer’s maintenance
bility of Subcommittee E55.03 on General Pharmaceutical Standards.
recommendations and maintenance schedule to establish an
Current edition approved Feb. 1, 2013. Published March 2013. Originally
appropriate maintenance program based on the frequency of
approved in 2007. Last previous edition approved in 2007 as E2503 – 07. DOI:
10.1520/E2503-13E01. apparatus use and quality system requirements.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

------------------
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1
Designation: E2503 − 13 E2503 − 13
Standard Practice for
1
Qualification of Basket and Paddle Dissolution Apparatus
This standard is issued under the fixed designation E2503; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1
ε NOTE—Editorial corrections made throughout in April 2015.
1. Scope
1.1 This practice covers the set-up and calibration of the paddle and basket dissolution apparatus.
1.2 Use of this practice may be applied to apparatus that have been modified to enable automatic dissolution testing (that is,
a valve in the bottom of the vessel or sampling through the shaft).
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory
limitations prior to use.
2. Significance and Use
2.1 This practice outlines a procedure for the mechanical calibration of paddle and basket dissolution units to ensure
reproducibility of results.
2.2 Once a unit meets all of the mechanical specifications included in this practice, it is considered calibrated and further
calibration with dissolution calibrator tablets is not required.
3. Analyst Responsibilities
3.1 Verify the vessel, basket, and paddle dimensions on receipt through measurement or Certificate of Analysis (COA) or
Certificate of Conformity (COC).
3.2 Ensure the instrument is calibrated and fit for performing dissolution analysis.
4. Procedure
4.1 Background—The set-up, mechanical, and operational checks are used to minimize variability during dissolution testing to
ensure the reproducibility of dissolution results.
4.2 Wherever possible, tools shall be traceable to an accepted standard calibration source from a national or international
calibration laboratory.
4.3 Apparatus Set-up—During apparatus installation or after replacement of parts or components, verify that the description and
critical dimensions for each part meets the original description and dimension.
4.3.1 Vessel Dimensions—In the absence of a COA or COC, the vessel’s internal dimensions should be measured with an
appropriate measuring device and vessel shape and condition should be noted. For example, for a cylindrical, hemispherical vessel,
the vessel’s sides must be cylindrical, the internal dimension should be measured, and the vessel bottom should be smooth and
without defects. The vessel must fit within the apparatus in such a manner as to ensure stable operation and centering of the shaft
in the vessel.
4.3.2 Basket/Shaft Dimensions—In the absence of a COA or COC, an appropriate measuring device is used to measure the
relevant basket dimensions. Critical dimensions to be measured on each basket should include but are not limited to: shaft diameter,
1
This practice is under the jurisdiction of ASTM Committee E55 on Manufacture of Pharmaceutical Products and is the direct responsibility of Subcommittee E55.03 on
General Pharmaceutical Standards.
Current edition approved Feb. 1, 2013. Published March 2013. Originally approved in 2007. Last previous edition approved in 2007 as E2503 – 07. DOI:
10.1520/E2503-13.10.1520/E2503-13E01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
´1
E2503 − 13
vent hole diameter, thickness of wide portion of the basket-to-shaft adaptor, total basket height, internal diameter at the top of the
basket, outer diameter of the screen, height of the open screen, outer diameter of bottom, diameter of screen on the bottom, and
screen mesh number.
4.3.3 Paddle Dimensions—In the absence of a COA or COC, an appropriate measuring device is used to measure the relevant
dimensions of the paddle. Examples of dimensions to be determined on each paddle should include but are not limited to: shaft
diameter, blade height, blade thickness, total blade length, length of flat portion on bottom of blade, radius of the angle on the top
outer edge of the top of the blade, radius of the outside edge of the blade, difference between the distance from the midlin
...

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1.6 Abbreviated Terminology:  
1.6.1 Abbreviated terminology is intended to provide uniform contractions of terms relating to cannabis that have evolved through widespread common usage. The compilation in this standard has been prepared to avoid the occurrence of more than one abbreviated term for a given cannabis term and to avoid multiple meanings for abbreviated terms.  
1.6.2 The abbreviated terminology and descriptions in this standard are intended to be consistent with usage in the cannabis industry and the standards under D37 jurisdiction. Other ASTM committees may assign a different word-phrase description to the same abbreviated terminology. In such cases, the abbreviated terms in this standard shall apply to usage in D37 standards, or if widespread misunderstanding could result from conflicting abbreviated terminology descriptions, the abbreviated terminology for the word-phrase shall not be used in D37 standards.  
1.6.3 Acronyms and Initialisms—A word formed from the letters or parts of words of a longer word-phrase, usually from the initial letters or parts of the words. An acronym is pronounced as a word (for example, radar for radio detection and ranging). An initialism is pronounced as a series of letters (for example, DOT for Department of Transportation).  
1.6.4 The acronym or initialism description is the origin word-phrase for the acronym or initialism, not a definition.  
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM D7709-12(2023)(Test Method)
Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters

SIGNIFICANCE AND USE
5.1 The purpose of these test methods is to obtain reliable values for WVTR that can be used to discriminate among barrier packages for pharmaceutical products. These test methods will establish a WVTR value that represents the water vapor transmission of the container closure system being evaluated. They are intended for use in evaluating or comparing, or both, the water vapor barrier performance of alternative packages for use in packaging of pharmaceutical products.  
5.2 While these methods were developed for a specific, limited application, they should be suitable for most types and sizes of consumer packages.
SCOPE
1.1 The three test methods described herein are for measurement of water vapor transmission rates (WVTRs) of high-barrier multiple-unit containers (bottles), high-barrier single-unit containers (blisters), and quasi-barrier single-unit containers used for packaging pharmaceutical products. The containers are tested closed and sealed. These test methods can be used for all consumer-sized primary containers and bulk primary containers of a size limited only by the dimensions of the equipment and the weighing capacity and sensitivity of the balance.  
1.2 These test methods are intended to be of sufficient sensitivity and precision to allow clear discrimination among the levels of barrier packages currently available for pharmaceutical products.  
1.3 There are three methods: Method A is for bottles, Method B is for formed barrier blisters, and Method C is for formed quasi-barrier blisters. Methods B and C can be adapted for use with flexible pouches.  
1.4 These test methods use gravimetric measurement to determine the rate of weight gain as a result of water vapor transmission into the package and subsequent uptake by a desiccant enclosed within the package. The packages are exposed to environments typical of those used for accelerated stability testing of drug products in the package (typically 40 °C/75 % relative humidity [RH]).  
1.5 For these methods, balance sensitivity, amount of desiccant, number of blisters per test unit, and weighing frequency were developed in an experiment based on Test Methods E96/E96M.  
1.6 Test Methods E96/E96M gives specific instruction on the interactions among weighing frequency, number of data points necessary to establish steady state, minimum weight gain in a weighing period, and balance sensitivity.  
1.7 The test methods in this standard were developed specifically for pharmaceutical bottles and blisters as closed container-closure systems. The experiment from which the methods were developed provided an inter-laboratory study from which the precision and bias statement was written. The packages in the study were small bottles and blisters used regularly for pharmaceutical solid oral dosage forms.  
1.8 In spite of the specific nature of their application, the test methods in this standard should be suitable for other pharmaceutical packages and most types and sizes of other consumer packages.  
1.9 The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. The units of measure for bottles are milligrams per bottle per day (mg/bottle-day) and for blisters, milligrams per blister cavity per day (mg/cavity-day). These units may be used for both standard and referee testing.  
1.10 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.11 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Ba...

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ASTM
ASTM D8499-23(Guide)
Standard Guide for Meeting the Specifications of ASTM D8432

SIGNIFICANCE AND USE
4.1 Standards and practices for assuring safety, quality, and weight stabilization during key steps of the cannabis/hemp flowers’ sojourn are in order.  
4.2 This standard is intended to assure safety, quality, and weight stabilization of packaged cannabis/hemp flower during transit operations.  
4.3 This standard is intended to be used by purveyors who move the packaged cured flower between licensed operators or to the end user.  
4.4 This standard is intended to be used by samplers and testing laboratories transporting samples to a laboratory to assure that samples analyzed represent as accurately as possible, the material that was gathered to provide the sample for analysis.
SCOPE
1.1 Specification D8432 covers the environmental conditions, such as temperature, humidity, and lighting under which the cured, dry, cannabis/hemp flowers packaged in fresh format and intended for human use can be maintained in transit to assure the safety, quality, and weight stabilization of the packaged flower. This guide suggests means by which the purveyor of transportation of cannabis/hemp can meet those specifications.  
1.1.1 This standard does not apply to frozen cannabis/hemp.  
1.1.2 This standard does not apply to cannabis/hemp intended for extraction.  
1.2 This standard applies to controlling the environment surrounding packaged cannabis/hemp flower in transit, either within the package itself or in the environment surrounding the package, or both.  
1.3 This standard is to be followed by licensed operators in the cannabis/hemp space who move the packaged crop(s) through the distribution supply chain to another licensed operator or to the end user.  
1.4 Purveyors of cannabis/hemp flower include, but are not necessarily limited to: the packager, transportation companies, warehousing operations, and retail operations.  
1.5 Security of the packaged cannabis/hemp flower while in transit is not within the scope of this standard.  
1.6 This standard is intended to remain valid until ownership of the packaged cannabis/hemp flower is transferred to another licensed operator or to the final consumer.  
1.7 Authorities having jurisdiction may have additional or alternate requirements which shall take precedence or supersede this standard.  
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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