Testing Types
Nitrosamine Impurity (NDSRI) Testing

Nitrosamine Impurity (NDSRI) Testing

Advanced nitrosamine impurity testing to detect, identify, and quantify NDSRIs and other nitrosamine contaminants in pharmaceutical products, supporting patient safety 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 Nitrosamine Impurities?

Nitrosamines are a class of chemical impurities that may form in pharmaceutical drug substances and finished drug products during manufacturing, formulation, packaging, storage, or degradation. Their formation can occur when secondary or tertiary amines interact with nitrosating agents under certain processing or environmental conditions. Nitrosamines may also originate from raw materials, solvents, reagents, recycled materials, water systems, manufacturing equipment, or packaging components.

Several nitrosamines are considered potentially carcinogenic and may pose a health risk when exposure exceeds established acceptable intake limits. As a result, pharmaceutical manufacturers must evaluate their products for potential nitrosamine formation and implement appropriate control strategies.

At PLS Analytical, specialized nitrosamine testing programs support the detection, identification, quantification, and characterization of both common nitrosamines and Nitrosamine Drug Substance-Related Impurities, or NDSRIs. Our capabilities can support risk assessments, analytical method development and validation, confirmatory testing, root-cause investigations, and ongoing product monitoring. Using sensitive analytical techniques, PLS Analytical helps pharmaceutical companies evaluate trace-level impurities, demonstrate regulatory compliance, and maintain product quality and patient safety throughout the product lifecycle

What is Nitrosamine Impurity (NDSRI) Testing?

Nitrosamine and Nitrosamine Drug Substance-Related Impurity (NDSRI) testing involves the detection, identification, and quantification of potentially harmful nitrosamine impurities in pharmaceutical materials and products. Unlike certain small-molecule nitrosamines, NDSRIs are structurally related to the active pharmaceutical ingredient and may form when vulnerable amine groups within the drug substance react with nitrosating agents during manufacturing, formulation, storage, or degradation.

PLS Analytical provides sensitive analytical testing for nitrosamines and NDSRIs in drug substances, finished drug products, intermediates, excipients, and raw materials. Using advanced chromatographic and mass spectrometric techniques, our laboratory supports trace-level impurity detection, analytical method development and validation, confirmatory testing, impurity characterization, root-cause investigations, process-change evaluations, stability studies, and regulatory submissions.

Why it Matters

Regulatory agencies have established stringent acceptable intake limits for many nitrosamines due to their potential carcinogenic risk. Failure to appropriately assess, identify, and control these impurities may result in additional regulatory investigations, manufacturing delays, product recalls, or restrictions on product distribution.

A comprehensive nitrosamine testing program helps pharmaceutical manufacturers evaluate potential risk, confirm impurity levels, determine the source of formation, establish appropriate control strategies, and demonstrate that products meet applicable quality and regulatory expectations throughout their lifecycle.

PLS Analytical delivers scientifically robust, regulatory-aligned testing programs that help manufacturers evaluate nitrosamine risks, characterize NDSRIs, and generate reliable data to support FDA, EMA, MHRA, and other global regulatory requirements throughout the product lifecycle.

Testing Services

Detect and control nitrosamine risks with confidence

PLS Analytical performs nitrosamine impurity testing using advanced analytical technologies to support risk assessments, regulatory submissions, process evaluations, and ongoing quality programs.

1. Nitrosamine Screening & Risk Assessment Support

Nitrosamine screening and risk assessment support evaluate pharmaceutical products and materials for potential nitrosamine contamination. Scientifically robust data supports drug substance evaluations, product risk assessments, regulatory compliance, and proactive impurity control strategies.

2. NDSRI Identification & Quantification

NDSRI identification and quantification evaluate Nitrosamine Drug Substance-Related Impurities (NDSRIs) at trace concentration levels. Scientifically robust data supports complex pharmaceutical products, impurity characterization, control strategies, and regulatory submissions.

3. Stability & Investigational Nitrosamine Studies

Stability and investigational nitrosamine studies evaluate nitrosamine formation throughout product storage, manufacturing changes, and quality investigations. Scientifically robust data supports stability programs, process change evaluations, lifecycle management, and long-term nitrosamine control.

Advantages

Built for reliable, regulatory-ready impurity assessment

Nitrosamine testing provides the sensitive analytical data required to identify, quantify, and control one of the most closely scrutinized impurity classes in the pharmaceutical industry.

Highly Sensitive Detection

Advanced analytical methods enable the detection of nitrosamine impurities at extremely low concentrations, supporting compliance with stringent regulatory limits and safety expectations.

Improved Product Safety

Early identification and control of nitrosamine risks help protect patients, reduce quality concerns, and support long-term product integrity.

Risk-Based Quality Management

Testing data supports nitrosamine risk assessments, root cause investigations, process improvements, and lifecycle quality strategies designed to minimize impurity formation.

Loading...