Testing Types
Extractables & Leachables Testing

Extractables & Leachables Testing

Comprehensive extractables and leachables studies to evaluate packaging material-product interactions, support patient safety, and demonstrate regulatory compliance across pharmaceutical packaging and delivery systems.

Terms and Conditions

I. Confidentiality:

PLS Analytical ("PLSA") maintains strict confidentiality with its clients.

Formal Confidentiality agreements may be initiated by the client or by PLS Analytical.

II. Financial Information

Payment in advance is required for clients whose credit has not been established with PLSA.
Payment terms are “NET 15 days from receipt of the results”. Buyer agrees to pay all costs, including, but not limited to attorney and accounting fees and other expenses of collection resulting from any default by buyer in any of the terms of this contract.
Purchase orders or valid credit card information are REQUIRED. Orders submitted without this information may cause delays in testing.
For third party billing a signed purchase order must be received from the party paying for the service.
A surcharge of 50% or greater will be added for EXPRESS service. Express is subject to prior approval and availability.
Pricing is designed for single samples. Project discounts may be available. Quotations will be provided free of charge.
A minimum billing of $25.00 will be charged on all samples including those samples cancelled at the customer's request.
Clients that request Raw Data will have a copy sent to them electronically (at no charge) along with their report. There may be a surcharge for copies of the raw data and report when requested after initial sending is completed.
Additional charges may be assessed (e.g. hazardous samples, composite fee).
Shipping costs will be charged to clients that would like containers, coolers or ice packs returned.
Liability of PLSA is limited to an amount no greater than the amount invoiced.

III. Sample Submission:

Fill out the Sample Submission Form COMPLETELY, including product name, lot number, test, methods, and the amount of samples sent. Incomplete information may cause a delay in providing services.
All results will be reported by the method supplied and/or identified. If a limit is not supplied, we will default to associated compendia limits, or “Report Results” when compendial limits are not available.
All samples should be labelled with company name, product name and lot number. Samples received without a lot number will be sent back to the client for proper labeling. Hazardous Substances must be appropriately labeled for the protection of office and laboratory personnel.
- Shipping carton exterior must be labeled as to the hazard enclosed; caustic, cytotoxic, antineoplastic, explosive, corrosive, toxic, or carcinogenic, etc.
- Safety Data Sheet (SDS) must be provided for all Hazardous samples.
- Additional charges may be applied.
- Please place Sample Submission Form, SDS and any other correspondence submitted, in an envelope and place at the top of the box or affixed to the outside of the box. Failure to use the PLSA Submission Form for Analytical Services may delay results.

IV. Retention and Disposal:

Samples are retained for a period of 30 days after completion of analysis.
Special PRIOR arrangements must be made to return or retain samples under other conditions.
Unless alternate arrangements have been made, raw data will be retained for 6 years after final report date.

IMPORTANT

Turnaround Times:
- In calculating turnaround times, pending all appropriate documentation is in order; if the sample is received before 10 am then the day the sample is received is Day 1 otherwise it will be on the next business day.
- Standard TAT is 10 Business days.
- Express Service is subject to prior approval, availability and surcharges.
- For International orders, please allow sufficient time for samples to clear customs.
Please pack samples appropriately to prevent breakage.
Because transportation of materials to our facilities can have significant impact on the moisture content of client sample materials, PLS Analytical will not accept client-provided Loss on Drying/Moisture content results. When required for testing, the Loss on Drying/Moisture Content will be performed at PLS Analytical and will be billed to clients at a flat rate. Please contact our Customer Service Team for current associated costs.
If growth is obtained during microbial enrichment testing, a gram stain will be performed and billed to the client. Please contact our Customer Service Team for current associated costs.
For Questions regarding the above information please contact our Client Services Department at 732-698-5050.

I confirm that I have read and accept the terms and conditions.

Sample Submission Form

Submitter Information

Date

Company Name / Address

Contact Name

Billing

Send Invoice To

If differentSame as Report

Name and email for invoicing

Order References

PO Number*

Quote Number*

Turn Around Time

StandardRush

Express, needed byInclude Raw Data

Controlled substance

Yes No

Microbiology sample suitability

YesNo

Analytical sample: method verification required

YesNo

Special Instructions

Fill The Sample Columns

SAMPLE NAME	LOT # (ONE LOT PER LINE)	METHOD (MUST BE PROVIDED)	TEST REQUESTED (MUST BE PROVIDED)	SPECIFICATION (MUST BE PROVIDED)	QUANTITY

Required for Testing to Begin Customer Initials and Date

Overview

What are Extractables & Leachables?

Extractables are substances that migrate from packaging materials under laboratory stress conditions (e.g., elevated temperatures and pH conditions, aggressive solvents). Leachables are chemical compounds that may migrate from packaging systems, manufacturing components, and other product-contact materials into pharmaceutical products. At PLS Analytical, E&L studies help manufacturers identify potential packaging-material-related leachables, evaluate their impact on product quality and patient safety, and support informed packaging and process decisions.

What is Extractables & Leachables Testing?

PLS Analytical performs extractables and leachables testing to identify, characterize, and quantify compounds that may migrate into pharmaceutical products. Extractables studies establish a profile of potential chemical migrants, while targeted leachables studies evaluate actual migration under intended storage and use conditions. These programs support product development, packaging qualification, process validation, stability studies, and regulatory submissions.

Why it Matters

Packaging materials and process-contact components can introduce trace-level contaminants that may affect product quality, stability, or patient safety if not properly evaluated. As packaging systems, single-use technologies, and advanced drug delivery devices become increasingly complex, comprehensive E&L assessments are essential for understanding and controlling material-related risks.

PLS Analytical delivers scientifically robust E&L studies aligned with USP <1663>, USP <1664>, FDA, and global regulatory expectations, helping manufacturers generate reliable data for packaging qualification, regulatory submissions, and lifecycle quality management.

Testing Services

Evaluate material-product interactions with confidence

PLS Analytical performs extractables and leachables studies to support packaging qualification, process validation, regulatory submissions, stability programs, and ongoing product quality management. We have expert scientists and advanced technology to support the testing needs of our customer, with equipments like LCMS/GCMS/ ICPMS

1. Extractables Studies

Extractables studies evaluate potential chemical compounds that may migrate from pharmaceutical packaging materials, manufacturing components, and product-contact systems. Scientifically robust data supports packaging qualification, single-use system evaluations, product development, and contamination risk assessments.

2. Leachables Assessment

Leachables assessment evaluates compounds that migrate into pharmaceutical products under intended storage and use conditions. Scientifically robust data supports stability programs, product registration, commercial manufacturing, patient safety assessments, and regulatory submissions.

3. Risk Assessment & Regulatory Support

Risk assessment and regulatory support evaluate extractables and leachables data to guide safety assessments and regulatory decision-making. Scientifically robust data supports NDA, ANDA, IND, and BLA submissions, packaging changes, lifecycle quality management, and regulatory compliance.

Advantages

Built for reliable, regulatory-ready material safety assessment

Extractables and leachables testing provides critical scientific evidence supporting product safety, packaging suitability, and regulatory compliance.

Enhanced Patient Safety

Testing identifies potential chemical contaminants before they become product quality or patient safety concerns, helping manufacturers establish effective control strategies.

Comprehensive Material Understanding

Extractables profiles provide valuable insight into packaging materials and process-contact systems, enabling informed material selection and risk management decisions.

Early Risk Identification

Proactive E&L assessments help identify contamination risks during development and qualification stages, reducing the likelihood of late-stage investigations, reformulation efforts, or regulatory delays.

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