Testing Types
Elemental Impurity Testing

Elemental Impurity Testing

Sensitive elemental impurity analysis to detect and quantify trace metal contaminants in pharmaceutical products, supporting patient safety, product quality, and regulatory compliance.

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 Elemental Impurities?

Elemental impurities are trace metallic contaminants that may be introduced into pharmaceutical products through raw materials, manufacturing processes, equipment, packaging systems, or environmental exposure. At PLS Analytical, elemental impurity assessments help manufacturers identify, quantify, and control these contaminants to support product quality, patient safety, and regulatory compliance.

What is Elemental Impurity Testing?

PLS Analytical performs elemental impurity testing to detect and quantify trace metals in drug substances, finished products, excipients, process materials, and packaging components. Using highly sensitive analytical instrumentation, our studies generate quantitative data that supports raw material qualification, process validation, stability programs, commercial release, regulatory submissions, and ongoing quality risk management.

Why it Matters

Elemental impurities cannot be identified through routine product inspection and often require highly sensitive analytical methods for accurate detection. Because these contaminants may originate from multiple stages of manufacturing and are subject to strict regulatory limits, effective monitoring is essential for maintaining product quality and protecting patient safety.

PLS Analytical delivers scientifically robust elemental impurity testing aligned with ICH Q3D, USP <232>/<233>, FDA, and global regulatory expectations, helping manufacturers establish effective control strategies, support regulatory submissions, and maintain compliance throughout the product lifecycle.

Testing Services

Evaluate and control trace metal contamination with confidence

PLS Analytical performs elemental impurity testing to support product development, material qualification, process assessments, stability programs, and regulatory compliance activities.

1. Drug Product Elemental Impurity Testing

Drug product elemental impurity testing evaluates finished pharmaceutical products for regulated elemental impurities. Scientifically robust data supports commercial release programs, product quality assessments, regulatory submissions, and compliance with established safety thresholds.

2. Raw Material & Excipient Assessment

Raw material and excipient assessment evaluates pharmaceutical ingredients for potential elemental contamination prior to manufacturing. Scientifically robust data supports API qualification, excipient control strategies, supplier qualification, material risk assessments, and proactive impurity control.

3. Process & Investigation Studies

Process and investigation studies evaluate manufacturing processes to identify potential sources of elemental impurities. Scientifically robust data supports root cause investigations, process validation, manufacturing change evaluations, corrective actions, and process improvement initiatives.

Advantages

Built for reliable, regulatory-ready impurity assessment

Elemental impurity testing provides the analytical data needed to identify, quantify, and control trace metal contaminants throughout the pharmaceutical product lifecycle.

Enhanced Patient Safety

Testing helps identify elemental contaminants that may present toxicological concerns, supporting safe product use and long-term patient protection.

Comprehensive Risk Management

Analytical data supports risk-based assessments of raw materials, manufacturing processes, and finished products, enabling informed control strategies and quality decisions.

Early Identification of Contamination Sources

Routine monitoring and investigative studies help identify impurity sources before they affect product quality, reducing the likelihood of compliance issues, investigations, and manufacturing disruptions.

Regulatory Compliance

Elemental impurity testing supports compliance with ICH Q3D requirements and global regulatory expectations related to elemental impurity risk assessment and control. Testing documentation can support regulatory submissions, inspections, audits, validation activities, and lifecycle quality management programs.

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