Industries

Aerospace & Defense

EAG is your R&D partner, working with aerospace and defense manufacturers and suppliers to create faster, safer and more reliable aircraft and components. We use the most advanced…

EAG is your R&D partner, working with aerospace and defense manufacturers and suppliers to create faster, safer and more reliable aircraft and components. We use the most advanced analytical methodologies to answer complex engineering, materials and manufacturing problems, from evaluating the purity of new materials to confirming the characteristics of ceramic matrix composites. For research, development and production, we work alongside your technical staff to formulate and troubleshoot the next generation of aerospace and defense materials.

Chemicals & Basic Materials

For over 50 years, EAG’s scientists have applied advanced analytical techniques to solve tough problems and support R&D activities for manufacturers and users of a wide variety…

For over 50 years, EAG’s scientists have applied advanced analytical techniques to solve tough problems and support R&D activities for manufacturers and users of a wide variety of chemicals and materials. EAG offers reliable analytical results, development support for novel products, and answers to complex problems for manufacturers of chemicals used in metals, fibers, plastics, coatings, adhesives, construction materials, textiles, lubricants and more.

Consumer Products

Consumer products manufacturers and partners turn to EAG to answer R&D questions, ensure supply chain quality, respond to regulatory requirements and ensure well-supported legal…

Consumer products manufacturers and partners turn to EAG to answer R&D questions, ensure supply chain quality, respond to regulatory requirements and ensure well-supported legal arguments. EAG scientists have helped all types of consumer products companies accelerate innovation, resolve manufacturing concerns and comply with evolving regulations.

Food & Agriculture

Drive R&D productivity and keep pace with evolving environmental regulations. From agrochemical development to evaluating innovative packaging solutions, EAG scientists support…

Drive R&D productivity and keep pace with evolving environmental regulations.

From agrochemical development to evaluating innovative packaging solutions, EAG scientists support the agriculture/food s industry with scientific expertise required to enhance shelf life, ensure product safety and understand environmental impact. Whether in need of food quality investigations or help supporting regulatory filing of new chemicals, ask EAG. WE KNOW HOW.

Law

When a business’s brand and reputation is at stake, clients turn to EAG’s litigation support services for dependable scientific answers. Since 1959, our scientific expertise,…

When a business’s brand and reputation is at stake, clients turn to EAG’s litigation support services for dependable scientific answers. Since 1959, our scientific expertise, testing and testimony have supported legal strategies for intellectual property, product liability and insurance cases. Our scientists offer expertise in technology, life sciences, electronics, industrial and consumer products, having tested a broad array of materials for legal challenges. We understand the unique needs of legal projects – speed, effective communication, reliability and confidentiality.

Medical Device & Diagnostics

From initial concept and prototypes to verification/validation, submission and launch, EAG Laboratories is your partner in medical device development. From implant…

From initial concept and prototypes to verification/validation, submission and launch, EAG Laboratories is your partner in medical device development. From implant biocompatibility studies to surface chemistry for contact lenses, we have the experience and techniques to characterize, test and assure purity of medical devices and their materials, components, products and packaging. By utilizing our unique expertise in materials sciences, chemistry, electronics and regulatory support, EAG empowers device companies to create new ways to heal and improve patient quality of life.

Pharmaceuticals

Overcome R&D roadblocks with technical and regulatory know-how. For over two decades, EAG scientists have helped solve complex issues for the pharmaceutical Industry. Using…

Overcome R&D roadblocks with technical and regulatory know-how. For over two decades, EAG scientists have helped solve complex issues for the pharmaceutical Industry. Using multidisciplinary science and engineering, we help improve product development efficiency, avoid regulatory setbacks and uncover sources of problematic manufacturing issues. From GLP and cGMP studies to contaminant and packaging investigations, the scientists of EAG support every phase of the product lifecycle.

Technology

For the high-tech industry, EAG is the leader in materials characterization, surface analysis, microscopy and electronics testing. Our scientists and engineers troubleshoot and…

For the high-tech industry, EAG is the leader in materials characterization, surface analysis, microscopy and electronics testing. Our scientists and engineers troubleshoot and solve issues with consumer electronics, chip packages, printed circuit boards, displays, sensors, high-speed communications and more. We meet the demanding needs of technology innovation, enabling our clients to have confidence in their research & development, supply chains, and ultimately their manufacturing processes

Services

Pharmaceutical & Biopharmaceutical Development Services

EAG brings unparalleled expertise to the development and commercialization of small molecule drugs, biopharmaceuticals, antibody-drug conjugates (ADCs), drug-device combination…

EAG brings unparalleled expertise to the development and commercialization of small molecule drugs, biopharmaceuticals, antibody-drug conjugates (ADCs), drug-device combination products and other therapies. From designing IND-enabling studies to delivering full CMC analytical and QC support, we join your R&D team as a true partner. EAG scientists take time to understand both your commercial goals and the unique characteristics of your compound. We provide expert guidance to balance regulatory expectations with expediency and cost, and approach technical challenges with flexibility and resolve.

Materials Testing & Analysis

When it comes to understanding the physical structure, chemical properties and composition of materials, no scientific services company offers the breadth of experience, diversity…

When it comes to understanding the physical structure, chemical properties and composition of materials, no scientific services company offers the breadth of experience, diversity of analytical techniques or technical ingenuity of EAG. From polymers to composites, thin films to superalloys—we know how to leverage materials sciences to gain a competitive edge. At EAG, we don’t just perform testing, we drive commercial success—through thoughtfully designed investigations, technically superior analyses and expert interpretation of data.

Environmental Testing & Regulatory Compliance

Having helped develop the test methods that shape current regulatory guidelines, EAG chemists, biologists and toxicologists have evaluated the environmental impact of thousands of…

Having helped develop the test methods that shape current regulatory guidelines, EAG chemists, biologists and toxicologists have evaluated the environmental impact of thousands of active ingredients and formulations—from pesticides and pharmaceuticals to industrial chemicals and consumer products. Whether you are exploring “what if” scenarios, registering a new active ingredient or formulation, responding to a data call-in or seeking to understand the latest guidance, turn to EAG for technical excellence, sound advice, GLP-compliant study execution and expert interpretation.

Microelectronics Test & Engineering

Whether connecting the internet of things, guiding surgical lasers or powering the latest smart phone, integrated circuits and microelectronics touch nearly every aspect of human…

Whether connecting the internet of things, guiding surgical lasers or powering the latest smart phone, integrated circuits and microelectronics touch nearly every aspect of human life. In the world of technology, innovation and continuous improvement are imperatives—and being able to quickly and reliably test, debug, diagnose failures and take corrective action can make the difference between a doomed product launch and building a successful global brand. EAG offers you the world’s largest and most diverse collection of specialized analytical instrumentation, capacity to perform a variety of microelectronic tests in parallel, and the multi-disciplinary expertise required to draw true insight from data.

Custom Synthesis & Radiolabeling

No contract service provider has more experience performing custom synthesis and producing isotopically labeled compounds to support product development in life science, chemical…

No contract service provider has more experience performing custom synthesis and producing isotopically labeled compounds to support product development in life science, chemical and related industries than we do. From 14C and 3H radiolabeled clinical trial materials synthesized under cGMP, to stable-labeled active ingredients for metabolism and environmental fate/effects testing, turn to EAG. We have extensive experience with multi-step and other complex synthesis projects, and our comprehensive, in-house analytical services ensure quick turnaround of purity and structural confirmation.

Crop Biotechnology & Development

EAG combines biotechnology and protein characterization expertise with more than 50 years' experience analyzing chemical compounds in plant and environmental matrices to address…

EAG combines biotechnology and protein characterization expertise with more than 50 years’ experience analyzing chemical compounds in plant and environmental matrices to address the growing needs of the biotechnology crop industry. We offer a wide range of techniques required to fully characterize the event insertion and expressed proteins, as well as the various studies required to confirm the food, feed and environmental safety of products that represent the trait. From early-stage protein confirmation to GLP-compliant EDSP and allergenicity testing, we help you make faster, more informed development decisions and comply with evolving global regulations of genetically engineered crops.

Litigation Support & Expert Testimony

When you need solid science and investigative engineering to address product failures, inform legal strategy, protect intellectual property or address product liability disputes,…

When you need solid science and investigative engineering to address product failures, inform legal strategy, protect intellectual property or address product liability disputes, turn to EAG. We’ve provided technical consulting, analysis and expert testimony for hundreds of cases involving the aerospace, transportation, medical device, electronics, industrial and consumer product industries. Our team of experts understands the legal process and your need for responsiveness, effective communication, scientifically defensible opinion and confidentiality. From professional consulting to data review to trial preparation and expert witness testimony, ask EAG.

Techniques

Chromatography

Using an array of advanced separation techniques and innovative technology, we conduct highly precise analytical chromatography for various industries. Whether you want a closer…

Using an array of advanced separation techniques and innovative technology, we conduct highly precise analytical chromatography for various industries. Whether you want a closer look at the purity of your pharmaceutical or need to better understand an agrochemical’s components, EAG has the expertise to separate and evaluate any compound.

Mass Spectrometry

Need to evaluate the molecular structure of a compound or identify its origins? EAG knows how. With state-of-the-art tools, we can separate, vaporize and ionize the atoms and…

Need to evaluate the molecular structure of a compound or identify its origins? EAG knows how. With state-of-the-art tools, we can separate, vaporize and ionize the atoms and molecules in almost any pure or complex material to detect and obtain mass spectra of the components. We rely on decades of experience in mass spectrometry to provide our clients with precise analyses and the best detection limits.

Imaging

EAG is a world leader in high-resolution imaging down to the atomic level. We offer unmatched analytical know-how, generating extremely detailed surface and near surface images…

EAG is a world leader in high-resolution imaging down to the atomic level. We offer unmatched analytical know-how, generating extremely detailed surface and near surface images for various industries, from consumer electronics to nanotechnology. Using state-of-the-art equipment and innovative techniques, we conduct expert imaging to aid in failure analysis, dimensional analysis, process characterization, particle identification and more. If you want to investigate a material with angstrom scale resolution, you can count on EAG to get the job done quickly and precisely.

Spectroscopy

EAG offers a vast array of spectroscopic techniques to clients in various industries, from defense contractors to technology pioneers. We combine unparalleled expertise and…

EAG offers a vast array of spectroscopic techniques to clients in various industries, from defense contractors to technology pioneers. We combine unparalleled expertise and methodology with cutting-edge technology to analyze your organic, inorganic, metallic and composite materials for identification, compositional, structural and contaminant information. Whether you need expert spectroscopic analysis to improve your production process or to surmount a technical challenge, EAG is up to the task.

Physical/Chemical Characterization

Need to identify your unique material? Want to analyze the thermal properties of a sample, or measure the success of a process step? If it has to be done quickly and it has to be…

Need to identify your unique material? Want to analyze the thermal properties of a sample, or measure the success of a process step? If it has to be done quickly and it has to be done right, you can count on EAG. We offer a range of adaptable techniques and innovative methods to evaluate the physical and chemical characteristics of any compound. Our highly precise testing and analytical services will improve your production process, expedite R&D and help you conquer any technical challenge.

About

A Global Scientific Services Company

One of the most respected names in contract research and testing, EAG Laboratories is a global scientific services company operating at the intersection of science, technology and…

One of the most respected names in contract research and testing, EAG Laboratories is a global scientific services company operating at the intersection of science, technology and business. The scientists and engineers of EAG apply multi-disciplinary expertise, advanced analytical techniques and “we know how” resolve to answer complex questions that drive commerce around the world.

Our Customers

Science and technology transcend industry boundaries, and so does demand for EAG’s expertise. We partner with companies across a broad spectrum of high-tech, high-impact and…

Science and technology transcend industry boundaries, and so does demand for EAG’s expertise. We partner with companies across a broad spectrum of high-tech, high-impact and highly regulated industries. We help our customers innovate new and improved products, investigate manufacturing problems, perform advanced analyses to determine safety, efficacy and regulatory compliance, and protect their brands.

Our Company Culture

EAG’s corporate culture is firmly rooted in four guiding principles: “foster a growth mindset,” “find a better way,” “earn more loyal customers,” and “win…

EAG’s corporate culture is firmly rooted in four guiding principles: “foster a growth mindset,” “find a better way,” “earn more loyal customers,” and “win together.” Across all of our 20+ locations, you will find a true passion for science and the power of science to improve the world we live in. Hear what some of our ~1200 scientists, engineers and support personnel say about what it means to be part of EAG Laboratories.

Careers

EAG is growing, and we are always looking for talented, problem-solving oriented individuals to join our company. If you have a “we know how” spirit, we want to hear from you.…

EAG is growing, and we are always looking for talented, problem-solving oriented individuals to join our company. If you have a “we know how” spirit, we want to hear from you. Browse current openings now, and re-visit our careers page often.

How do you make better development decisions faster?

How to Evaluate Manufacturer-Provided Extractable Information

WHITE PAPER

By Wayland Rushing, Ph.D., Allan R. Moorman, Ph.D.

Different types of pharmaceutical products

Abstract

Purpose: Extractables and Leachables (E&L) is a challenging topic to address during product development. A successful E&L program depends on whether the program design is based on the correct information on the container/closure system. The first critical step is the initial material characterization (determination of extractables) of the container/closure system to understand what can possibly migrate into the final drug product as a leachable. If the data from these studies is not applicable or insufficient for a sponsor’s product, it can lead to regulatory delays or recalls. Most of the container/closure systems used today are not proprietary but are purchased from component manufacturers. As part of a service to their clients, many of these providers now offer extractable information on their products. However, the usefulness of this information can vary widely from manufacturer to manufacturer. The challenge for sponsors is to understand what information they need, what questions to ask their vendors, and how to evaluate the information for their specific application. This presentation will walk through a process for ensuring the right questions are asked and how that information should be evaluated.

Methods: A stepwise process will be presented that will enable companies to ensure they are asking the correct questions when interacting with their container/closure vendors. An example risk assessment and gap analysis process will be presented that covers how the data can be evaluated against a sponsor’s specific drug product.

Results: Representative case studies will be presented in applying the process to data provided by the component manufacturer.

Conclusions: By starting the extractables and leachables evaluation early, sponsors can avoid potential delays in their development time line, avoid recalls and, most importantly, avoid jeopardizing patient safety.

Definitions

Extractable
Compounds that can, under aggressive laboratory conditions, migrate out of materials

Leachable
– Normally a subset of extractables
– Compounds that migrate into the drug product

Extractable ≠ Leachable
– Extractables don’t always leach
– Leachables don’t always extract

Sources of Extractables/Leachables
  • Primary packaging components
  • Secondary packaging components
  • Associated/dosing components
  • Processing components
  • Shipping materials

Regulatory Basis for Evaluation of Extractables/Leachables

The regulatory requirements for the evaluation of extractables and leachables are found within the Code of Federal Regulations (CFRs), as shown in the tables below. The regulations indicate that the requirements for all contact materials (i.e. final packaging system and manufacturing equipment) are the same.

Code of Federal Regulations (CFRs) for Extractables/Leachables

Code of Federal Regulations (CFRs) for Extractables/Leachables

Regulatory Guidance:
Several guidances are available from the FDA which addresses extractables and leachables:

  • Guidance for Container Closure Systems for Packaging Human Drugs and Biologics (1999)
  • Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (1993)
  • Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI) (1998)
  • Nasal Spray and Inhalers Solution, Suspension, and Spray Drug Products (2002)
  • Inhalation Drug Products Packaged in Semipermeable Container Closure Systems (2002)

While the above information from the FDA addresses E&L studies, it doesn’t go into specifics in how the studies need to be performed. For guidance on performing E&L studies industry best practices documents can be used for designing studies. Some of the groups that have guidances available are:

  • Product Quality Research Initiative (PQRI)
  • Bio-Process Systems Alliance (BPSA)
  • Biophorum Operations Group (BPOG)

Additionally, the USP has drafted new chapters, which are currently under review, for guidance on E&L studies:

  • <1163> and <1164>
Background

Given the rise in E&L expectations, many component manufacturers have started providing extractable data on their materials. These data packages vary in the level of detail and in how the information was collected. This is not unexpected given the following:

  • Lack of regulatory guidance of requirements
  • No regulatory requirement for the component manufacturer to perform the studies
    • Mainly provided as a sales aid
  • Manufacturer does not know all of the possible products and dosing regimens which a company might use their product with

As a result, the usefulness of these packages can vary significantly. It is important for a company to have a process in place to evaluate the information provided by the manufacturer (if any), and to determine whether the information is applicable to their product or whether additional studies will need to be performed. The following is a summary of a detailed process which can be used in walking through some of the main questions to be asked and in how to evaluate the information collected.

Evaluation Process

Step 1: Questions to ask the Vendor

The key to starting the evaluation is to ensure you have asked the correct information and have it available. This requires going to the manufacturer and obtaining as much information as possible on the contact materials, their materials of construction, etc. Below are some example questions which should be posed.

Is there a DMF?

  • Drug Master Files (DMFs) can help some level of confidence in the vendors materials. However, it needs to be understood that the FDA does not approve DMF’s. The review them with each new drug which references them. Just because the FDA found the DMF suitable for one use does not necessarily mean it will be found appropriate for another compounds.
  • One of the common deficiencies observed in relation to DMF’s is that they are not applicable to the Drug/usage in question.

Is there an extractables data package?

  • Some manufacturers have started an extractables program on their own materials and have made these packages available to the client. Some provide a limited package free of charge, while other companies have a package that can be purchased.
  • The level of detail and usefulness of this package will vary from vendor to vendor.

Has the component been used in a successful filing?

  • This allows for some comfort that the material is being used commercially.
  • As with the DMF caveat above, the FDA will review the component in regards to your specific drug product (DP) and application. Just because it was found to be acceptable for another product does not guarantee that the component will be found appropriate for a different product.

Are multiple resin sources available for polymeric components?

  • Some manufacturers allow for the use of polymeric resins from multiple sources. This can complicate the extractables profile as each source is unique. Extractables data on each resin will be needed.

Different grades of resins?

  • Grades of polymeric resins can have a direct impact on extractables profiles. When choosing a polymeric component, ensure that the decision is based on quality, not just pricing.

Are all components made in the same facility/line?

  • If components are made in multiple lines or multiple facilities, then an extractable package should be performed on each material.

What testing is performed on the components for release? i.e. How is variation controlled?

  • Does the vendor test the components for extractables as part of a release test.
  • These can be important, especially if your product has a high risk for potential leachables. It can help minimize variation in observed peaks.

Will they implement a supply agreement?

  • This is critical so that the customer is notified of any changes in the process. Polymeric components are not manufactured in accordance in cGMPs in many cases, as a result more variation can be tolerated.

Step 2: Perform Risk Assessment and Gap Analysis on the information provided.

Once the information from the above questions is received it is important to then evaluate the data in terms of the specific drug product and the specific application. Without a good evaluation process it can leave the company open to higher risk that there could be delays or surprises in the development.

Were chemical extractions performed or list of “possible” extractables given based on manufacturing process?

  • Some vendors don’t perform testing on their components, but rather provide information based on the formulation of the component.
  • Information based solely on formulation is of limited use, as the specific extractables are often not easily predicted and impurities in the formulation products are not well characterized even though than can often be a source of leachables.

How were the chemical extractions performed?

  • A typical extraction profile is as follows:
    • Multiple Solvents: Must cover a broad range of solvent polarities, including ones representative of the drug formulation.
    • Multiple Extraction Techniques: Should consider the proper extraction techniques to use, such as reflux, microwave, soxhlet., as well as various sample preparation approaches (whole, cut,ground).
    • Asymptotic Extractions: Samples are taken from the extractions over time and analyzed to ensure that the maximum level of extractables are being removed.
  • Care should be taken to avoid being too aggressive on the extractions, to avoid physically or chemically altering the product being extracted.
  • Were the analytical methods used in the analysis appropriate/validated?
    • The potential extractables in polymeric material can have a very wide range of chemical properties. It is critical that the analytical methods used are able to cover the full range of potential compounds.
      • HPLC – Semi-Volatiles and Non-Volatiles
      • GC – Volatiles
      • ICP – For metals
      • Special Case Extractables
        •      Poly-aromatic Hydrocarbons (PAH’s)
        •      Nitrosamines
        •      2-Mercaptobenzothiazole

Did the analytical methods go low enough?

  • This is the most common shortcoming of data packages provided by manufacturers. See the following section for calculation of the Analytical Evaluation Threshold (AET) and the Case Study examples

Evaluation of Supply/Shipping chain

  • While very rare, shipping materials have been known to be the source of leachables. Additionally, how the materials are packaged and shipped from the manufacturer are important to understand.
Commonly Observed Gaps/Deficiencies
  • Solvent(s) used in extraction studies not representative of the Drug Product formulation
  • Asymptotic extractions were not performed
  • Reporting level of the data is higher than the determined AET.
  • Insufficient number of analytical methods used in analysis of extracts.
  • Inadequate detail in reporting extractables
    • Compounds not properly identified, e.g. “phosphite based anti-oxidant” or “proprietary curing agent”
    • Compounds named based upon formulation rather than actual identity, e.g. silicone oil

How Low To Go

One of the most challenging and common deficiencies is that the analytical methods didn’t go low enough for a specific drug products formulation/dosing regimen.

No direct regulatory guidance is available

  • ICH guidelines for general impurities do not apply
  • Genotoxic Impurities Guidance – 1.5 µg/day
  • Ophthalmics1 – 1 ppm reporting, 10 ppm Identification, 20 ppm Qualification

Safety Concern Threshold (SCT)

  • Level below which there is negligible risk associated with the toxicity of the extractable/leachable compound, based upon dosing
  • Only applies to unknowns
  • Presented as a Total Daily Intake (TDI): usually in µg/day
  • Product Quality Research Institute (PQRI) recommends 0.15 µg/day for inhalation products
  • Current thinking of PQRI Parenteral and Ophthalmic Drug Product (PODP) working group is 1.5 µg/day for parenteral products

Using the PQRI’s idea of the Safety Concern Threshold we can convert that to an equivalent analytical level for a specific product. The conversion takes into account the drug’s specific dosing regimen and the number of doses which are in each container/closure system. Example equations for converting the AET into a number of different units, depending on the usage, are shown below.

Example equations for converting the AET into a number of different units,

1Ng, Linda (CDER/FDA), “Current Regulatory Recommendations for Leachables in Ophthalmic Drug Products,” Thresholds and Best Practices for Parenteral and Ophthalmic Drug Products, 22-23 February 2011, Bethesda, MD.

Case Study #1

One of the most critical issues in extractable evaluations is ensuring that the data you are making the decision meets the expectations based on the best practices recommendations. This requires evaluating the information for the specific drug product formulation and worst case scenario dosing regimen for a product. The following case study demonstrates that information provided by a manufacturer may be adequate for some cases but not acceptable for others.

The product is a parenteral with an aqueous formulation (same formulation for both scenarios) in a 20 mm glass vial with a 3.0 gram rubber stopper. The stopper manufacturer has provided an extractables package that used analytical methods with a quantitation limit (QL) of 5ppm. Asymptotic extractions were performed using water and IPA.

We will review the package against two different container closure scenarios:

Extractable packaging configuration

For the evaluation of the data we are going to examine two specific items:

1. Extraction Solvent(s) vs. DP formulation

– The extraction solvents used (water and IPA) cover the polarity range of the DP formulation (aqueous) used above. In terms of extraction solvents used, the data provided by the manufacturer are applicable to the product.

2. QL of the extraction methods vs. AET needed

– Applying a 1.5 µg/day SCT, based on the PQRI current thinking for parenterals, we are able to compare the expected reporting level against the data provided by the manufacturer.

As can be seen in the table, for scenario 2, we are able to use the data provided by the manufacturer for evaluating the extractables profiles, however in the case of scenario 1, the analytical methods used didn’t go low enough.

Case Study #1 summary: The data provided by the manufacturer can be used for the evaluation in scenario 2. However, the data are not adequate for evaluating against the dosing regimen in scenario 1. As a result, it is likely that additional studies would be needed to achieve the lower QL required by the AET.

Case Study #2

For this example we will evaluate another parenteral product with an oil based formulation (cottonseed oil) in the same container/closure system as in Case Study #1. The stopper manufacturer has provided an extractables package that used analytical methods with a quantitation limit of 5ppm. Asymptotic extractions were performed using water and IPA.

We will review the package against the following configuration:

Two Different container closure scenarios

For the evaluation of the data we are going to evaluate the same two items as we did in case study #1:

1. Extraction Solvent(s) vs. DP formulation

– The extraction solvents (water and IPA) are not representative, nor do they cover the polarity range of the formulation(cottonseed oil). As a result they would not be predictive of leachables in the product.

2. QL of the extraction methods vs. AET needed

– Applying a 1.5 ug/day SCT, based on the PQRI current thinking for parenterals, we are able to compare the expected reporting level against the data provided by the manufacturer.

As can be seen in the table, the QL (5ppm) and extractables data provided by the manufacturer does go low enough compared to the AET required for the drug product.

Case Study #2 summary: Based on the extraction solvent mis-match, the data provided by the manufacturer cannot be used in evaluation for the drug product. New studies would be required.

Another case study for extractables data
Summary

It is important to use the correct information and process to ensure that the development process is not delayed as a result of an E&L issue. By having the right information available, it is possible to avoid some of the most common pitfalls that can result in regulatory delays for products by having a well-defined process in place when choosing the container/closure system.

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