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ASTM D7709-11e1

(Test Method)

Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters

Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters

SIGNIFICANCE AND USE
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.  
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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
31-Mar-2011
ICS
11.120.99 - Other standards related to pharmaceutics
Technical Committee
D10 - Packaging
Current Stage
Ref Project

Relations

Replaces
ASTM D7709-11 - Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters
Effective Date
01-Apr-2011
Replaced By
ASTM D7709-12 - Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters
Effective Date
01-May-2012

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ASTM D7709-11e1 - Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and BlistersASTM D7709-11e1 - Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters
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ASTM D7709-11e1 - Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters
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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:D7709–11
Standard Test Methods for
Measuring Water Vapor Transmission Rate (WVTR) of
1
Pharmaceutical Bottles and Blisters
This standard is issued under the fixed designation D7709; 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
´ NOTE—Section X1.3 and Table X1.1 were corrected editorially in September 2011.
1. Scope container-closure systems. The experiment from which the
methods were developed provided an inter-laboratory study
1.1 The three test methods described herein are for mea-
from which the precision and bias statement was written. The
surement of water vapor transmission rates (WVTRs) of
packages in the study were small bottles and blisters used
high-barrier multiple-unit containers (bottles), high-barrier
regularly for pharmaceutical solid oral dosage forms.
single-unit containers (blisters), and quasi-barrier single-unit
1.8 Inspiteofthespecificnatureoftheirapplication,thetest
containers used for packaging pharmaceutical products. The
methods in this standard should be suitable for other pharma-
containers are tested closed and sealed.These test methods can
ceutical packages and most types and sizes of other consumer
be used for all consumer-sized primary containers and bulk
packages.
primary containers of a size limited only by the dimensions of
1.9 The values stated in SI units are to be regarded as the
the equipment and the weighing capacity and sensitivity of the
standard. No other units of measurement are included in this
balance.
standard. The units of measure for bottles are milligrams per
1.2 These test methods are intended to be of sufficient
bottle per day (mg/bottle-day) and for blisters, milligrams per
sensitivity and precision to allow clear discrimination among
blistercavityperday(mg/cavity-day).Theseunitsmaybeused
the levels of barrier packages currently available for pharma-
for both standard and referee testing.
ceutical products.
1.10 This standard does not purport to address all of the
1.3 There are three methods: Method A is for bottles,
safety concerns, if any, associated with its use. It is the
Method B is for formed barrier blisters, and Method C is for
responsibility of the user of this standard to establish appro-
formed quasi-barrier blisters. Methods B and C can be adapted
priate safety and health practices and determine the applica-
for use with flexible pouches.
bility of regulatory limitations prior to use.
1.4 These test methods use gravimetric measurement to
determine the rate of weight gain as a result of water vapor
2. Referenced Documents
transmission into the package and subsequent uptake by a
2
2.1 ASTM Standards:
desiccant enclosed within the package. The packages are
E96/E96M Test Methods for Water Vapor Transmission of
exposed to environments typical of those used for accelerated
Materials
stability testing of drug products in the package (typically
40°C/75 % relative humidity [RH]).
3. Terminology
1.5 For these methods, balance sensitivity, amount of des-
3.1 Definitions:
iccant, number of blisters per test unit, and weighing frequency
3.1.1 barrier blister, n—blister made from high-barrier
were developed in an experiment based on Test Methods
material, formed and sealed so that the water vapor transmis-
E96/E96M.
sion rate (WVTR) (when tested at 40°C/75 % RH) is less than
1.6 Test Methods E96/E96M gives specific instruction on
1.0 mg/cavity-day.
the interactions among weighing frequency, number of data
3.1.2 blister, n—formed, lidded and sealed plastic dome
points necessary to establish steady state, minimum weight
that contains the solid oral product (usually one unit).
gain in a weighing period, and balance sensitivity.
3.1.2.1 Discussion—Synonymous with cavity.
1.7 The test methods in this standard were developed
3.1.3 card, n—contiguous group of blisters formed and
specifically for pharmaceutical bottles and blisters as closed
sealed with lid in place.
1
This test method is under the jurisdiction of ASTM Committee D10 on
2
Packaging and is the direct responsibility of Subcommittee D10.32 on Consumer, For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Pharmaceutical and Medical Packaging. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved April 1, 2011. Published April 2011. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
D7709-11. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

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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.  
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5.1 The analysis and reporting of cannabinoid content in cannabis and hemp is required to address human health and safety concerns, satisfy testing and labeling requirements, and meet the regulatory guidelines of various jurisdictions. This test method is useful in providing quantitative results for up to seventeen cannabinoids in dried cannabis and hemp raw material samples.
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1.1 This test method allows for the concentration determination of the cannabinoids listed in Table 1, and shall apply to any dried raw material from a cannabis plant (Note 1, Note 2) regardless of the type of cannabis plant from which it was derived.2 For the sake of brevity, the term “cannabis” shall be used from now on to refer to any type of cannabis plant including those that can be classified as hemp. The procedure includes sub-sampling a ground, homogeneous sample, extraction with methanol:water (80:20, v:v),3,4 dilution in methanol and analysis by liquid chromatography tandem mass spectrometry (LC-MS/MS). The method allows for a wide-range of sample concentrations to be determined by using a 1000-fold calibration range and the option to perform multiple levels of sample dilution. The calibration curve is prepared in methanol over a range of 10 ng/mL to 10 000 ng/mL for all seventeen cannabinoids, or a subset of cannabinoids if desired, while the sample extracts are diluted in methanol into the calibration range.3,4,5 For example, a 1/500 dilution of sample extracts allows concentration determination over a range of 0.5 mg/g to 500 mg/g in cannabis. The method was validated with quality control samples prepared in methanol, a candidate certified reference material (CRM), and repeat extraction and analysis of cannabinoid samples.3  
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Standard Test Method for Multi-residue Analysis of Pesticides in Dried Cannabis and Hemp Raw Materials Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

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5.1 The analysis and reporting of pesticide content in all forms of cannabis raw material that is grown or processed or both, with the intent of ingestion or consumption, is required to address health and safety concerns, satisfy testing and labeling requirements, and meet the regulatory guidelines of various jurisdictions where cannabis has been legalized for ingestion or consumption for medicinal or recreational purposes, or both. This test method is useful in providing quantitative results for the analytes listed in Table 1, which is a subset of the pesticide testing requirements found in regulatory documents for cannabis, not limited to and including Canada, many U.S. states where legalization has occurred, and the European Pharmacopeia (1-4). This test method may be appropriate for additional pesticide and growth regulator analytes, which may be added to those of Table 1 provided validation is performed in accordance with Practice D8282. Analytes may be removed from Table 1 without additional validation.
SCOPE
1.1 This test method allows for the concentration determination of the pesticides listed in Table 1 and shall apply to any dried raw material from a cannabis plant (Note 1, Note 2) regardless of the type of cannabis plant from which it was derived (1, 2).2 For the sake of brevity, the term “cannabis” shall be used from now on to refer to any type of cannabis plant including those which can be classified as hemp. The procedure includes sub-sampling a ground, homogenous sample, liquid-solid extraction with acetonitrile:acetic acid (100:1, v:v), solid phase extraction with C18 SPE media, dilution in 3 mM ammonium formate in water with 0.1 % formic acid and 3 mM ammonium formate in methanol with 0.02 % formic acid in a 20:80 ratio (v:v) and analysis by LC-MS/MS. This procedure encompasses the entire process from sample preparation to analyte quantitation encompassing a range of 0.005 µg/g to 0.500 µg/g.  
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Note 1: For this test method, dried raw material from a cannabis plant includes one or more of inflorescence, leaves, or stems.
Note 2: Certain jurisdictions or regulations may require specific parts of the plant to be included or excluded for analysis and those regulations will take precedence for the selection of plant parts.  
1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 Table 1 lists the analytes measured by this test method.  
1.4 No recommendations found within this test method shall preclude observance of federal, state, or local regulations, which may be more restrictive or have different requirements.  
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5.3 There are many different types of hardware technologies that address the comminution of dried cannabis or hemp; however, the list of devices is exhaustive and thus beyond the scope of this guide. See Table 3 and Table 4  (16-18) for a summary of different milling technologies. Distinctions among various pieces of equipment often relate to the type, mass, and size/shape of the sample (dry, fibrous) for which each is most effective. In addition, there may be economic reasons for mill selection, that is, the sample throughput of the testing laboratory (number of samples per day), access to cryogenics, and sample mass requirements.    
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5.5 The sample size for comminution purposes is limited as the analytical testing portion required is often 500 times smaller than the bulk sample lot and not every testing laboratory is equipped to handl...
SCOPE
1.1 In this guide, the basic steps in obtaining a test portion sample of either dried cannabis/hemp inflorescence are outlined.  
1.2 Sample preparation depends on many factors including moisture (dryness) of the sample, the analyte to be measured, the concentrations/amounts, and the test method's precision and accuracy requirements. In this case, dried cannabis or hemp plant material require particle size reduction-comminution from a representative sample of which the final analytical testing portion is determined by the employed testing method. Local regulatory guidelines often dictate both the representative sample that is taken from the bulk material (harvest batch) and the final mass of the test portion (for example  
1.3 This guide will not purport to meet every local and state jurisdiction since different regulatory requirements vary; the local/state requirements are at the discretion of the user to follow and interpret.  
1.4 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.5 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.  
1.6 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 D8439-22(Specification)
Standard Specification for Medicinal-use Cannabis Inflorescence

SCOPE
1.1 This standard defines the specifications (appropriate tests, their analytical methods and acceptance criteria) for the identification, strength (for example, cannabinoid content), and purity (for example, limits for contaminants) for medicinal-use cannabis inflorescence.  
1.2 This specification references approved analytical methods used to verify the specifications, and in the absence of approved analytical methods, a suggested method for validating such specifications.  
1.3 Units—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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 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 D8452-22(Guide)
Standard Guide for Requirements for Medical-related Professionals within the Cannabis and Hemp Industries

SIGNIFICANCE AND USE
5.1 As patient use of cannabis and hemp for medical purposes increases and medical professionals are increasingly called upon to provide medical advice, the following requirements and expectations within the medical profession are increasingly significant, requiring:  
5.1.1 Availability by patients to qualified medical professionals who can provide safe and objective advice on the medical use of cannabis and hemp,  
5.1.2 Clarity by medical professionals on the legal restrictions in their area of jurisdiction to ensure compliance, and  
5.1.3 Development of qualified training and certificate programs to ensure safe and quality healthcare for patients.  
5.2 The primary objectives of this guide are as follows:  
5.2.1 Provide a general overview of the BoK required for the professions listed in Section 7; and  
5.2.2 Provide recommendations to form the foundation for training and subsequent recognition/certificate systems that enable consumers, employers, organizational management, government agencies, and others who rely upon medical professionals to distinguish between qualified and non-qualified workers.  
5.2.3 Recommend requirements that agencies can use to develop and document the specific criteria used for training or certificate programs.  
5.3 Users of this guide shall document deviations from the recommended requirements to inform their clients of the criteria applied in either the training or the certificate programs offered. As the cannabis and hemp industries and medical guidelines mature, this guide will be updated to reflect current thinking and requirements.  
5.4 The Bok elements are applicable to certificate programs, while the BoK, experiential and educational elements are applicable to certification process requirements.
SCOPE
1.1 This guide can provide certification bodies, training providers, employers, and certificate issuers, with best-practice guidance for administering their respective programs for medical-related professions within the cannabis and hemp industries.  
1.2 This guide recommends requirements for experience, training, education, and the body of knowledge (BoK) necessary for medical-related professions within the cannabis and hemp industries listed in Table 1.  
1.3 For purposes of this guide, a medical professional is defined as a person qualified and licensed as required by the jurisdiction to provide guidance or recommendations regarding a person's health or fitness.  
1.4 This guide provides recommendations for articulating professional requirements for training and education or earning certificates. It is part of a series of guides denoting certification requirements for professions within the cannabis and hemp industries (Guides D8346, D8347, D8348), and supporting Practice D8403 for associated certificate programs.  
1.5 This guide's content does not supersede requirements for training or earning a certificate defined by jurisdictional entities such as government or other regional regulatory bodies.  
1.6 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.  
1.7 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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