Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Elements and Compounds01:27

Elements and Compounds

105.1K
Pure substances consist of only one type of matter. A pure substance can be an element or a compound. An element consists of only one type of atom, while a compound consists of two or more types of atoms held together by a chemical bond.
Elements
Elements are classified as atomic or molecular based on the nature of their basic units. They are unique forms of matter with specific chemical and physical properties that cannot break down into smaller substances by ordinary chemical reactions. There...
105.1K
Periodic Classification of the Elements04:00

Periodic Classification of the Elements

59.3K
The periodic table arranges atoms based on increasing atomic number so that elements with the same chemical properties recur periodically. When their electron configurations are added to the table, a periodic recurrence of similar electron configurations in the outer shells of these elements is observed. Because they are in the outer shells of an atom, valence electrons play the most important role in chemical reactions. The outer electrons have the highest energy of the electrons in an atom...
59.3K
Classification of Elements and Compounds02:54

Classification of Elements and Compounds

73.3K
Pure substances consist of only one type of matter. A pure substance can be an element or a compound. An element consists of only one type of atom, while a compound consists of two or more types of atoms held together by a chemical bond. Elements are classified as atomic or molecular based on the nature of their basic units.
Compounds are pure substances composed of two or more elements in fixed, definite proportions. Compounds are classified as ionic or molecular (covalent) based on the bonds...
73.3K
Key Elements for Plant Nutrition02:35

Key Elements for Plant Nutrition

24.3K
Like all living organisms, plants require organic and inorganic nutrients to survive, reproduce, grow and maintain homeostasis. To identify nutrients that are essential for plant functioning, researchers have leveraged a technique called hydroponics. In hydroponic culture systems, plants are grown—without soil—in water-based solutions containing nutrients. At least 17 nutrients have been identified as essential elements required by plants. Plants acquire these elements from the...
24.3K
Elements: Chemical Symbols and Isotopes02:31

Elements: Chemical Symbols and Isotopes

126.4K
A chemical symbol is an abbreviation used to indicate an element or an atom of an element. For example, the symbol for mercury is Hg. The same symbol is used to indicate one atom of mercury (microscopic domain) or to label a container of many atoms of the element mercury (macroscopic domain).
Some symbols are derived from the common English name of the element; others are abbreviations of the name in another language — Latin, Greek or German. For example, the symbol for aluminum (common name)...
126.4K
The Periodic Table and Organismal Elements00:57

The Periodic Table and Organismal Elements

203.2K
Overview
203.2K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

<i>In Silico</i> Assessment of Biomolecule Reactivity with Leachables.

PDA journal of pharmaceutical science and technology·2024
Same author

Characterizing Extractables and Leachables Chemical Space to Support In Silico Toxicological Hazard Assessments.

PDA journal of pharmaceutical science and technology·2024
Same author

Transitioning from development to commercial: risk-based guidance for critical materials management in cell therapies.

Cytotherapy·2020
Same author

Injectable Combination Product Development: Facilitating Risk-Based Assessments for Efficiency and Patient Centric Outcomes.

Journal of pharmaceutical sciences·2020
Same author

Evaluation of Particle Techniques for the Characterization of Subvisible Particles From Elastomeric Closure Components.

Journal of pharmaceutical sciences·2020
Same author

The human complement receptor type 2 (CR2)/CR1 fusion protein TT32, a novel targeted inhibitor of the classical and alternative pathway C3 convertases, prevents arthritis in active immunization and passive transfer mouse models.

Molecular immunology·2018
Same journal

A PAT-aligned framework for installing and operating particle counting systems to detect pre-limit particle-size distribution shifts in ISO-8 (non-sterile) controlled areas.

PDA journal of pharmaceutical science and technology·2026
Same journal

Using Positive Controls to Define the Defect Detection Range for CCIT Method Development and Validation.

PDA journal of pharmaceutical science and technology·2026
Same journal

Patient-Centric Drug Delivery: Establishing Injection Hold Time Limits for Large Volume Autoinjectors.

PDA journal of pharmaceutical science and technology·2026
Same journal

Gas flow through micro-capillaries â which flow law is most suitable to predict the flow rate through micro-capillaries?

PDA journal of pharmaceutical science and technology·2026
Same journal

Peer Review.

PDA journal of pharmaceutical science and technology·2026
Same journal

In-situ Verification of Disinfection Rotation for Contamination Control.

PDA journal of pharmaceutical science and technology·2026
See all related articles

Related Experiment Video

Updated: Feb 7, 2026

Preparation of Monodomain Liquid Crystal Elastomers and Liquid Crystal Elastomer Nanocomposites
12:21

Preparation of Monodomain Liquid Crystal Elastomers and Liquid Crystal Elastomer Nanocomposites

Published on: February 6, 2016

13.6K

Assessment of Extractable Elements from Elastomers.

Diane Paskiet1, Crystal Kraft1, Erica Tullo1

  • 1West Pharmaceutical Services, Inc. Exton, PA, USA.

PDA Journal of Pharmaceutical Science and Technology
|July 22, 2018
PubMed
Summary
This summary is machine-generated.

New United States Pharmacopeia (USP) methods address elemental impurities in drug products, but a gap remains for packaging. This study developed extraction methods for elastomeric components, finding most elements below critical thresholds.

Keywords:
ElastomerElemental impuritiesExtractables and leachablesICH Q3DParenteral packaging materialsUSP <231>/<232>/<233>

More Related Videos

Synthesis of Soft Polysiloxane-urea Elastomers for Intraocular Lens Application
11:49

Synthesis of Soft Polysiloxane-urea Elastomers for Intraocular Lens Application

Published on: March 8, 2019

13.2K
Fabrication Process of Silicone-based Dielectric Elastomer Actuators
10:32

Fabrication Process of Silicone-based Dielectric Elastomer Actuators

Published on: February 1, 2016

34.7K

Related Experiment Videos

Last Updated: Feb 7, 2026

Preparation of Monodomain Liquid Crystal Elastomers and Liquid Crystal Elastomer Nanocomposites
12:21

Preparation of Monodomain Liquid Crystal Elastomers and Liquid Crystal Elastomer Nanocomposites

Published on: February 6, 2016

13.6K
Synthesis of Soft Polysiloxane-urea Elastomers for Intraocular Lens Application
11:49

Synthesis of Soft Polysiloxane-urea Elastomers for Intraocular Lens Application

Published on: March 8, 2019

13.2K
Fabrication Process of Silicone-based Dielectric Elastomer Actuators
10:32

Fabrication Process of Silicone-based Dielectric Elastomer Actuators

Published on: February 1, 2016

34.7K

Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Materials Science

Background:

  • Traditional compendia methods for heavy metals lack elemental specificity and accuracy.
  • The International Council for Harmonization (ICH) Q3D guideline introduced a risk-based approach for elemental impurities in drug products.
  • The United States Pharmacopeia (USP) updated its procedures (<232>, <233>) aligning with ICH Q3D, but these apply only to drug products, not packaging.

Purpose of the Study:

  • To address the gap in assessing extractable elements from pharmaceutical packaging components, specifically elastomeric materials.
  • To investigate the potential for elements to leach from elastomeric packaging and contribute to drug product elemental impurity profiles.
  • To develop and validate extraction conditions and analytical techniques for evaluating elemental impurities from elastomeric components.

Main Methods:

  • Investigated multiple extraction conditions for elastomeric components.
  • Utilized modern analytical techniques for element detection and quantification.
  • Focused on elements of interest based on ICH guidelines and potential occurrence in elastomers.

Main Results:

  • Most investigated elements were recovered at levels below designated thresholds.
  • The study demonstrated that extractable elements from elastomeric components can contribute to drug product elemental impurities.
  • Recovered element levels allowed for correlation to permitted daily exposures (PDEs).

Conclusions:

  • Developed and validated methods for assessing extractable elemental impurities from elastomeric packaging.
  • While extractables exist, their contribution to the overall drug product impurity profile requires comprehensive risk assessment.
  • The findings support a more complete elemental impurity assessment strategy, encompassing both drug products and their packaging.