Key Analytical Techniques in E&L Testing 

When it comes to pharmaceutical and biopharmaceutical development, ensuring the safety of your product isn’t just about the drug itself—it’s also about everything that touches it. Packaging materials, delivery systems, and container closures can all introduce unwanted chemical substances into your formulation. That’s where Extractables and Leachables (E&L) testing becomes crucial. At ResolveMass Laboratories Inc., we help pharmaceutical manufacturers stay ahead of regulatory expectations with precise, globally compliant E&L analytical methods that protect both product quality and patient safety.

Our experienced team uses a combination of high-end technologies like GC-MS, LC-MS/MS, ICP-MS, and FTIR to detect even trace levels of extractables and leachables. These substances may leach from plastic, rubber, or glass materials into drug products, especially injectables. By identifying and quantifying potential contaminants under both stressed and real-use conditions, we help ensure that your packaging components are not compromising your formulation. From elemental impurity analysis to full toxicological risk assessment, our E&L workflows are designed to meet the highest scientific and regulatory standards.

What Are Extractables and Leachables? (E&L)

When developing pharmaceutical products—especially injectables, inhalers, and other complex drug delivery systems—it’s not just the drug that demands scrutiny. The packaging and delivery materials themselves can pose hidden risks if not properly evaluated. This is where Extractables and Leachables (E&L) come into play, and understanding them is a critical part of ensuring pharmaceutical packaging safety.

Extractables: What They Are

Extractables are chemical compounds that can be forcibly extracted from packaging materials when exposed to harsh, exaggerated conditions such as high temperatures, aggressive solvents, or prolonged exposure times. These conditions are intentionally extreme to simulate a “worst-case scenario.”

Think of it as stress-testing the packaging. If a container closure system—like a vial stopper or a plastic syringe barrel—contains materials like polymers, adhesives, or inks, subjecting them to these conditions helps uncover what could potentially come out of them under real-life usage or storage over time.

Common extractables might include:

• Plasticizers
• Oligomers
• Antioxidants
• Lubricants
• Residual monomers
• Stabilizers

At ResolveMass Laboratories Inc., we use validated E&L analytical methods such as GC-MS and LC-MS to identify and quantify these extractables precisely and efficiently.

Leachables: The Real-World Concern

Leachables, on the other hand, are a different story. These are the compounds that actually migrate from the packaging or device materials into the drug product under normal storage, handling, or usage conditions.

Unlike extractables (which are potential risks), leachables are actual risks. They are what end up in the final product that reaches the patient. Because leachables interact directly with the drug product—sometimes altering its stability or safety—they must be identified, quantified, and assessed for toxicity.

Examples of leachables include:

• Phenolic compounds from rubber stoppers
• Volatile organics from plastic containers
• Heavy metals from glass or elastomers
• Acids, aldehydes, or degradation products from adhesives

Why Understanding E&L Is Critical

Understanding the relationship between extractables and leachables is essential because not every extractable becomes a leachable—but every leachable likely originated as an extractable.

This relationship informs the design of packaging, the selection of materials, and the risk assessment strategies required by regulators. For injectables, where the drug bypasses the body’s natural barriers, the bar for purity and safety is even higher.

At ResolveMass Laboratories, our in-depth knowledge and hands-on experience in E&L Analytical Methods ensure that both extractables and leachables are studied thoroughly—providing clients with defensible, regulatory-ready data and, most importantly, safer products for patients.

➡ Learn more about our approach to E&L testing

👉 Also read: E&L Studies for Pharmaceutical Packaging: A Step-by-Step Guide — A practical walkthrough of how extractables and leachables studies are conducted, interpreted, and used for regulatory success.

E&L Studies for Pharmaceutical Packaging: A Step-by-Step Guide

Key E&L Analytical Methods:

Gas Chromatography (GC-MS and Headspace GC)

For detection and quantification of volatile and semi-volatile organic compounds in extractables and leachables, Gas Chromatography (GC) coupled with Mass Spectrometry (MS), is one of the most reliable and commonly used methods in E&L analysis.

Headspace GC-MS (HS-GC-MS) is a go-to technique when it comes to identifying volatile organic compounds (VOCs)—things like residual solvents, low-molecular-weight monomers, or other reactive trace impurities that could leach out of packaging materials. What makes this method particularly useful is that it analyzes the vapor (or “headspace”) above a sample, so there’s no need to dissolve the material or break it down first. That means you get accurate results with minimal sample prep. It’s especially effective for spotting common VOCs such as ethanol, acetone, and methylene chloride, which are often present in plastic or rubber components used in pharmaceutical packaging and container closures.

Direct-injection GC-MS—often paired with programmable-temperature vaporizer (PTV) inlets—is your method of choice for detecting semi-volatile organic compounds. These are slightly heavier, more stable substances like phthalate plasticizers, phenolic antioxidants, oleamide, and siloxanes, all of which can migrate from packaging materials under certain conditions. Since these compounds don’t easily evaporate, they’re introduced directly into the GC system at carefully controlled temperatures. This helps prevent breakdown during analysis and ensures accurate detection, even at trace levels.

At ResolveMass Laboratories Inc., we deploy both HS-GC-MS and direct GC-MS in our ISO-accredited extractables testing laboratory. Our workflows are optimized to ensure full-spectrum detection of both VOCs and semi-VOCs, enabling accurate risk assessment and regulatory compliance.

Liquid Chromatography (HPLC-UV, LC-MS, LC-MS/MS)

While gas chromatography is ideal for volatile and semi-volatile compounds, liquid chromatography (LC) significantly broadens the analytical scope by enabling the detection of polar, thermally labile, and non-volatile compounds—many of which are common in pharmaceutical packaging systems. These include compounds that do not vaporize easily or degrade under heat, making LC an essential complement in comprehensive E&L studies.

High-Performance Liquid Chromatography (HPLC) with UV or diode array detection (DAD) is a go-to method for spotting UV-active leachables like aromatic stabilizers, antioxidants, and colorants. But it’s important to know that this technique only works well for compounds that absorb UV light strongly. When it comes to substances that don’t, or those present in very small amounts, we need more advanced tools.

That’s where LC-MS and LC-MS/MS (tandem mass spectrometry) takes place. These techniques let us screen broadly and with great sensitivity for a wide range of polar, heat-sensitive, and chemically diverse compounds—many of which wouldn’t show up with UV detection alone. Examples like surfactants, PEG oligomers, lubricants, and dye intermediates.

Tandem MS takes things a step further by breaking molecules into fragments, which helps us identify and quantify them more precisely using methods like Multiple Reaction Monitoring (MRM). And when we use high-resolution instruments such as Q-TOF or Orbitrap, we get even sharper accuracy, making it easier to spot both known and unknown compounds—even in complex mixtures.

Compound Type	Examples	Detection Method
UV-active leachables	Aromatic stabilizers, dyes	HPLC-UV / DAD
Surfactants & emulsifiers	Polysorbates, Tween 80	LC-MS/MS
PEG oligomers & excipients	PEG-400, PEG-600	LC-MS / LC-MS/MS
Lubricants & slip agents	Oleamide, stearamide	LC-MS/MS
Non-UV polymer additives	Dye intermediates, stabilizers	LC-MS/MS or High-Res MS

At ResolveMass Laboratories Inc., our analytical scientists use a combination of HPLC-UV, LC-MS, and LC-MS/MS techniques to deliver full-spectrum coverage of extractables and leachables.

Mass Spectrometry and Identification

Mass spectrometry (MS) is very important in extractables and leachables (E&L) testing, offering incredible sensitivity and detailed insight of chemical structures that other methods can’t match. By combining MS with separation techniques like gas or liquid chromatography, we can both identify and measure a wide range of compounds that might migrate from packaging or manufacturing materials.

High-resolution MS instruments, like Q-TOF or Orbitrap, precisely measure the mass-to-charge ratio (m/z) of ions, enabling accurate determination of molecular formulas and the ability to differentiate between compounds with closely similar masses.

At ResolveMass Laboratories Inc., we combine cutting-edge MS technology with expert analysis to deliver thorough and trustworthy E&L testing—helping our clients meet regulatory requirements and keep their products safe.

Elemental Impurity Testing (ICP-OES, ICP-MS)

Elemental impurity testing is a crucial part of extractables and leachables (E&L) analysis in pharmaceuticals. It helps detect harmful metals and metalloids—like lead, cadmium, tin, and residual catalysts—that can leach from packaging or manufacturing equipment into drug products. Since these impurities can impact patient safety, monitoring them closely is essential to meet global regulations like ICH Q3D and USP <232>/<233>.

To do this, labs use Inductively Coupled Plasma (ICP) techniques, which are highly sensitive and accurate for detecting metals. ICP-OES measures the light emitted by elements in a hot plasma and works well for elements found at higher levels (ppm). Meanwhile, ICP-MS combines plasma with mass spectrometry, allowing detection at ultra-trace levels (ppt or ppb), making it perfect for finding tiny amounts of toxic metals and ensuring products stay safe and compliant.

In practical workflows, the pharmaceutical sample—whether drug product, extract from packaging, or container closure—is typically prepared by acid digestion or water extraction to break down the matrix and release elemental impurities into solution form. This prepared solution is then introduced into the ICP instrument for analysis.

For example, consider a glass vial sealed with tin-based solder. Over time, trace amounts of tin could leach into the drug solution. ICP-MS can detect and quantify these trace levels of tin with exceptional precision, providing critical data on potential contamination and helping to ensure patient safety.

Spectroscopy (FTIR, UV-Vis) and Non-Chromatographic Techniques

Spectroscopic techniques like FTIR and UV-Vis add an important layer to E&L testing by helping identify chemical groups in residues that aren’t easily detected by chromatography. FTIR examines the solid residue after evaporation, revealing the presence of polymers like silicone oils or polyethylene through their unique molecular vibrations.

UV-Vis spectroscopy measures how much UV or visible light compounds absorb, which helps quantify UV-active substances such as stabilizers and colorants.

Additionally, bulk tests like Total Organic Carbon (TOC) and Non-Volatile Residue (NVR) measure the overall organic content in extracts. These serve as valuable checks to ensure the total amount of extractables aligns with what chromatography finds, confirming the completeness of the analysis.

Technique	Purpose	What It Detects	Typical Use	Example
FTIR Spectroscopy	Identify chemical families in non-volatile residues	Functional groups, polymer types (e.g., silicones, polyolefins)	Confirm polymer presence in residue after solvent evaporation	Detect silicone oil in packaging extract
UV-Vis Spectroscopy / DAD	Quantify UV-active compounds	Aromatic stabilizers, antioxidants, colorants	Assess UV-absorbing leachables, often coupled with HPLC	Measure phenolic antioxidants in extracts
Total Organic Carbon (TOC)	Measure total organic carbon content	All organic compounds as carbon content	Bulk estimate of organic contamination	Verify total organic extractables in sample
Non-Volatile Residue (NVR)	Measure total residue mass after solvent removal	All non-volatile extractables	Check total extractable load versus identified components	Quantify total extractables from packaging

Other Techniques (Ion Chromatography, Thermal Desorption, etc.)

Sometimes, specific types of extractables need specialized testing methods. For example, Ion Chromatography (IC) is great for spotting ionic impurities like chloride, bromide, or nitrite—things that might not show up in typical GC or LC-MS tests. Gas chromatography with special detectors, like Electron Capture Detectors (ECD), can zero in on halogenated compounds specifically.

There’s also thermal desorption GC-MS, which lets you analyse solid samples like tiny bits of polymers directly, without having to use solvents. Newer technologies like comprehensive two-dimensional GC (GC×GC) combined with time-of-flight mass spectrometry (TOF-MS) or solid sampling probes help uncover unknown contaminants that standard methods might miss.

Real-Time Case Study: E&L Study for Injectable Biologic

Project: Development of a monoclonal antibody injectable in prefilled syringes

Problem: Potential migration from rubber stopper and polycarbonate barrel

Approach:

• Extractables identified via GC-MS and LC-MS
• Leachables simulated at 25°C/60% RH for 6 months
• Detected 2 leachables at 0.6 ppm (identified as phenol derivatives)
• Toxicological risk assessed via Threshold of Toxicological Concern (TTC)
• Outcome: Packaging changed to fluoropolymer-lined stopper

Result:

• No observed leachables at 6 months
• Successfully passed EMA and FDA submission
• Saved potential redesigns

Validation and Data Analysis in E&L Testing

Getting trustworthy results in extractables and leachables (E&L) testing isn’t just about running samples — it requires careful method validation and thorough data analysis to ensure everything is accurate and reliable.

Method Validation:

Every analytical method used in E&L testing follows strict guidelines from USP and ICH, covering key parameters like:

• Sensitivity: Can the method detect very low levels of impurities?
• Linearity: Does the response increase proportionally with concentration?
• Accuracy: How close are the measured values to the true amounts?
• Precision: Are the results consistent when repeated?

This validation step guarantees the methods perform as expected in real-world testing.

Quantitation:

Once compounds are identified, they need to be quantified precisely. Labs typically use calibrated GC-MS or LC-MS systems for this, sometimes relying on surrogate standards if exact reference standards aren’t available — a common challenge in E&L testing due to the diversity of possible compounds.

Nonspecific Checks:

In addition to targeted quantitation, labs run bulk measurements like Non-Volatile Residue (NVR) and Total Organic Carbon (TOC) on extracts. These tests serve as an extra layer of assurance, confirming that the total amount of extractables detected chromatographically matches the overall organic load — helping catch anything that might slip through the cracks.

Data Analysis Workflow:

• The first step is calculating the Analytical Evaluation Threshold (AET) for the drug product — a safety limit above which any detected impurity must be investigated.
• Detected peaks above this threshold are flagged for further review.
• Each peak is then matched against spectral reference libraries to identify known compounds.
• For unknown peaks, additional techniques like Nuclear Magnetic Resonance (NMR) may be used to help figure out their structure.

At ResolveMass Laboratories Inc., this entire process is supported by qualified, validated software combined with expert scientific review to ensure nothing important is missed. The final report includes all significant extractables, their identities, concentrations, and any safety flags — providing clients with complete confidence in the safety and compliance of their pharmaceutical products.

The ResolveMass Advantage

ResolveMass Laboratories positions itself as a reliable partner for E&L challenges. We leverage decades of analytical chemistry experience and state-of-the-art instrumentation. As our services page highlights, our lab uses LC-MS/MS and GC-MS for volatile to non-volatile organics, ICP-MS for metals, and FTIR/UV-Vis for unknown identification. All methods are tailored to the client’s product and matrices. Our scientists not only run the assays but also help interpret results: we calculate AETs, flag potential risks, and advise on mitigation. ResolveMass’s focus on expertise, accuracy, and traceability has made it a trusted extractables testing laboratory and provider of leachables testing services to pharmaceutical and biopharma companies.

Future Trends

The field of E&L analytical methods continues to evolve.

Trend	What It Means	Why It Matters
Advanced Detection Technologies	Using next-gen instruments like GC×GC-TOF and high-field Orbitrap MS	Finds hidden compounds previously undetectable
Smarter Data Analysis	AI-powered software & expanded spectral databases	Speeds up identification, reduces errors
Green Chemistry Initiatives	Smaller sample sizes, eco-friendly solvents	Safer, more sustainable testing processes
Industry Collaboration & Standards	Groups like PQRI and ELSIE drive harmonization	Ensures consistent, trusted results worldwide
Core Principles Remain	Combining GC, LC, MS, ICP for comprehensive profiling	Maintains thoroughness & patient safety

👉 Don’t miss: E&L Testing for Inhalation and Nasal Drug Products — Understand the unique E&L challenges and analytical strategies for respiratory drug delivery systems.

Extractables and Leachables (E&L) Testing for Inhalation and Nasal Drug Products: A Step-by-Step Guide

Frequently Asked Questions

Q1: What are extractables and leachables, and why do they require special analytical methods?

Extractables are compounds that can be drawn out of packaging materials or components when exposed to aggressive solvents or conditions. Leachables are those compounds that actually migrate into the drug product under normal storage/use. Because these substances vary widely in volatility, polarity, and chemistry, no single test can find them all. Instead, a suite of sensitive E&L Analytical Methods is used – for example, headspace GC-MS, GC-MS, LC-MS/MS, ICP-MS, FTIR, etc – to cover volatiles, semi-volatiles, non-volatiles, and inorganics. This comprehensive approach ensures that even trace-level leachables are detected.

Q2: How often should E&L testing be performed during a drug product’s lifecycle?

Testing is typically done during development, before commercial launch, and may be repeated periodically or when there are changes in packaging materials, formulation, or manufacturing processes.

Q3: What is an Analytical Evaluation Threshold (AET) in E&L testing?

The AET is a concentration threshold above which any detected extractable or leachable must be reported and assessed for toxicological risk. It is calculated from the drug’s maximum daily dose and a chosen safety limit (often 0.1 µg/day or per ICH Q3E guidelines).

For example, if the allowed exposure is 0.15 µg/day and the daily dose is 100 mL, then AET = 0.0015 µg/mL. Any E&L Analytical Method peak above this concentration in the final product triggers further toxicology review. Calculating and applying the AET is a core part of data analysis in both extractables and leachables studies.

Q4: Are there differences in E&L requirements for different dosage forms?

Absolutely! Different dosage forms—like inhalation products, injectables, and oral tablets—have very different ways they interact with the body, so their E&L testing needs aren’t the same.

For example, inhaled drugs go straight into the lungs, which are super sensitive, so even tiny amounts of leachables can cause problems. Injectables go directly into the bloodstream, so the safety bar is set really high there, especially for metals and contaminants. Oral tablets pass through the digestive system, which is a bit more forgiving, so the limits can be less strict.

Also, the packaging materials differ—vials, syringes, blister packs—all can release different chemicals, so testing has to match what the drug will actually come into contact with.

Dosage Form	Key Considerations	Typical E&L Focus
Inhalation Products	Direct lung exposure; highly sensitive tissues	Ultra-low leachable limits; volatile & semi-volatile compounds; silicone oils from device components
Parenteral (Injectables)	Direct bloodstream entry; sterility critical	Very strict limits on elemental impurities; leachables from stoppers and seals; non-volatile residues
Oral Solids (Tablets, Capsules)	GI tract exposure; longer transit times	Leachables from blister packs, bottles; more relaxed thresholds compared to injectables
Topical and Transdermal	Skin absorption; local and systemic exposure	Focus on solvents, plasticizers, adhesives from patches or tubes

In short, E&L testing is tailored based on the dosage form to make sure it’s safe and meets all regulatory requirements, protecting patients no matter how they take their medicine.

Q5: What steps are involved in an E&L testing workflow?

Q6: What does “regulatory compliant E&L testing” mean?

It means performing extractables and leachables studies in full accordance with industry and agency guidelines. This includes designing studies per USP <1663>/<1664> and ICH recommendations, validating methods to USP/ICH standards, and documenting all procedures. A compliant lab uses proper controls, qualified instruments, and follows cGMP/GLP practices. The data report must clearly show how each threshold is calculated and which compounds were detected above it. ResolveMass follows these regulations rigorously, so its E&L testing services produce data ready for FDA/EMA review.

Q7: What role do FTIR and TOC play in E&L analysis?

FTIR and TOC (total organic carbon) are supplementary checks in E&L. FTIR is used on the residue left after solvent evaporation to identify chemical families (e.g. determining if a residue is silicone, polyethylene glycol, etc.). This helps catch compounds that GC-MS or LC-MS might miss (especially high-molecular-weight, non-volatile substances). TOC measures the total carbon content of an extract, giving an overall estimate of organic load. If TOC indicates a large extractable mass but targeted analysis finds little, this signals that additional unidentified substances may be present. Together, FTIR and TOC/NVR analyses ensure a comprehensive assessment of extractable content.

Q8: What are common challenges in E&L analytical methods?

Extractables and leachables analysis is inherently complex, and several key challenges often arise:

• Extremely low analyte levels: We’re often dealing with trace contaminants at nanogram-per-milliliter concentrations or even lower. Detecting such tiny amounts demands highly sensitive instruments and optimized methods.
• Matrix interference: Drug substances, excipients, or packaging materials can produce background signals that interfere with target analytes, making it tricky to confidently identify and quantify contaminants.
• Unknown compounds: Many leachables are unexpected or unknown, lacking reference standards or spectral data. This makes identification difficult without advanced tools.
• Detection limits for certain compounds: Some analytes don’t absorb UV light, are very polar, or are large molecules that don’t behave well in standard chromatographic systems—so they can escape detection.

To tackle these challenges, we use a combination of strategies:

• Advanced detection technologies: High-resolution mass spectrometry (HRMS) and tandem MS (MS/MS) enhance sensitivity and provide detailed structural information for confident identification.
• Careful sample preparation: Techniques like concentration steps, selective cleanup, and matrix removal help reduce interference and improve detection.
• Orthogonal analytical methods: Complementary techniques such as FTIR spectroscopy for non-volatile residues give additional confirmation.
• Robust quality controls: Running blanks, replicates, and spiked samples ensures method reliability and catches any analytical issues early.
• Data cross-checking: Analysts compare findings against known material composition, supplier information, and comprehensive chemical databases to assess the relevance and origin of detected peaks.

Lastly, every method undergoes thorough validation following USP and ICH guidelines to guarantee accuracy, precision, and reproducibility. This meticulous approach is essential to deliver reliable results that protect patient safety and meet regulatory expectations.

Q9: What types of compounds are commonly identified in an extractables testing laboratory?

In extractables testing, we encounter a broad range of chemical classes that can migrate from packaging or manufacturing materials into drug products. Commonly, these include:

• Metals and catalysts, such as tin, antimony, or lead, often introduced through container seals or equipment.
• Plasticizers like phthalates and adipates—these are additives that improve plastic flexibility but are known to leach out under certain conditions.
• Antioxidants, such as BHT and Irganox, which protect polymers from degradation but may be released into the product over time.
• Slip agents and lubricants—fatty acids like oleic and erucic acids, along with silicone-based lubricants—used in manufacturing processes but potential contaminants in the final product.
• UV stabilizers, such as benzophenones, that prevent light-induced damage to packaging but can also migrate into formulations.
• Polymers and oligomers, which represent small fragments or breakdown products of plastic materials like siloxanes or polyethers.
• Residual solvents, including ethanol or methylene chloride, which may remain from manufacturing or cleaning processes.
• Colorants and dyes from packaging or components that could leach.

Q10: How does ResolveMass Laboratories ensure data from E&L Analytical Methods benefit QA/QC?

ResolveMass brings deep analytical expertise and a full suite of validated methods to each project. We tailor the extraction and analysis strategy to the specific materials and drug matrix. For instance, in a leachables testing services project for a pre-filled syringe, we might extract the assembled syringe with saline at body temperature for the product’s shelf life, then run LC-MS/MS to find plasticizer peaks, and ICP-MS to find any tin or nickel from the components. All methods are performed in a GLP-compliant lab with qualified instruments. We not only generate the raw data but also interpret it: we calculate the AET, highlight any findings above that threshold, and often provide toxicological insight. This integrated approach ensures our results directly support QA/QC decision-making. For specialized E&L testing support, please contact us at ResolveMass Laboratories.

ResolveMass Laboratories Inc.: Experience, Expertise, and Trust You Can Count On

ResolveMass Laboratories Inc. is a trusted Canadian contract research organization offering a wide spectrum of specialized services spanning polymer synthesis, advanced analytical testing, and custom organic synthesis. With over a decade of experience supporting pharmaceutical, biotech, and industrial clients, we bring scientific precision and regulatory insight to every project. Our core capabilities include Polymer Synthesis and Characterization, Peptide Characterization, Organic Synthesis, Nitrosamine Testing and Analysis, PFAS Testing, and Extractable & Leachable Studies, as well as a broad suite of analytical techniques such as HPLC, GC-MS, MALDI-TOF, NMR, and FTIR. 

Our multidisciplinary team includes chemists, analytical scientists, and regulatory experts with advanced academic and industry backgrounds. We excel at developing customized, high-quality solutions—whether you need innovative polymer designs, impurity profiling, or confirmatory testing that meets global regulatory standards. 

Ready to Get Started?

📩 Contact our expert team
📞 Request a quote for method development
📅 Book a consultation with our scientists
🧪 Submit your sample for testing

1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2014). Q3D guideline for elemental impurities. https://database.ich.org/sites/default/files/Q3D_Guideline.pdf
2. Peters, R., & Patel, S. (2019). Extractables and leachables: Principles, strategies, and best practices. Journal of Pharmaceutical Sciences, 108(2), 478–490. https://doi.org/10.1016/j.xphs.2018.10.012
3. Karthik, K., & Agarwal, V. (2017). Advances in LC-MS for extractables and leachables analysis. Journal of Pharmaceutical and Biomedical Analysis, 135, 113–123. https://doi.org/10.1016/j.jpba.2016.10.036
4. Sullivan, K. M., & Ames, J. M. (2020). Use of high-resolution mass spectrometry in E&L studies. Analytical Chemistry Insights, 15, Article 1177390120931146. https://doi.org/10.1177/1177390120931146
5. Calvo, E., et al. (2018). Advances in Ion Chromatography and ICP-MS for the analysis of extractables and leachables in pharmaceutical products. Journal of Chromatography A, 1571, 132–145. https://doi.org/10.1016/j.chroma.2018.09.037
6. European Medicines Agency (EMA). (2017). Guideline on plastic immediate packaging materials. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-plastic-immediate-packaging-materials_en.pdf
7. Product Quality Research Institute (PQRI). (n.d.). Extractables and leachables working group reports. Retrieved from https://pqri.org
8. U.S. Food and Drug Administration (FDA). (1999). Guidance for industry: Container closure systems for packaging human drugs and biologics. https://www.fda.gov/media/70746/download

🧪 How to Choose the Right Analytical Testing Partner for Your Project

Selecting the right analytical service provider is not just a procurement decision — it’s a scientific and regulatory commitment. Here’s a step-by-step guide to ensure you’re making the right choice:

1. Define Your Analytical Needs Clearly

Before you start shortlisting labs, clarify:

• The type of sample (API, excipient, formulation)
• The regulatory requirements (ICH, USP, Health Canada, etc.)
• Specific testing (stability, dissolution, residual solvents, etc.)

2. Evaluate Technical Expertise and Instrumentation

Look for:

• Validated methods or custom method development
• Advanced instrumentation (e.g., UHPLC, TOC, FTIR, AAS)
• Experience with your compound class (e.g., peptides, polymers, controlled substances)

3. Ensure Regulatory Compliance

Check for:

• Certifications: ISO/IEC 17025, GLP, GMP
• Data integrity and audit trails
• Previous regulatory audit history or approvals

4. Review Sample Handling & Turnaround Time

Ask:

• What is their average turnaround time?
• How do they handle sample storage, stability, and chain-of-custody?

5. Check Data Reporting & Interpretation Support

A credible CRO should:

• Provide comprehensive, well-documented CoAs
• Be available for data interpretation and consultation
• Offer post-report clarification and support

6. Evaluate Cost vs. Value

Don’t just go for the lowest price. Consider:

• Depth of analysis
• Reporting quality
• Reputation and client support

7. Ask for Case Studies or References

Real-world success stories build trust:

• Ask for relevant case studies
• Request industry-specific references