Complex & Non-Routine Analytical Solutions
for Unique Testing Challenges

- When standard tests aren’t enough, our advanced laboratory delivers tailored, non-routine analytical solutions
to identify unknowns, impurities, and failure causes.

- Multi-Technique Integration

- Expert Problem-Solving Team

- Confidential & Compliant

Home » Complex and Non-Routine Analytical Solutions

Food & Beverage Testing

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Pharmaceutical Testing

Materials & Packaging Testing

Environmental Testing

Why Choose Us

When standard tests fall short, you need a trusted partner with advanced capabilities, proven expertise, and strict confidentiality to solve your toughest analytical challenges.

Integrated Multi-Technique Approach

LC-MS, GC-MS, NMR, ICP-MS, and advanced spectroscopy combined to solve the most complex problems.

Experienced Problem-Solving Team

A cross-disciplinary team of scientists with decades of experience in complex and non-routine analysis.

Confidential & Regulatory Compliant

NDA-backed processes aligned with ISO, GMP, and global regulatory standards to protect your sensitive data.

Rapid, Tailored Solutions

Agile project management to deliver actionable results within your critical timelines.

In today’s fast-paced industries, standard testing methods often fall short when faced with unique, complex, or high-risk projects.

Our laboratory specializes in solving non-routine analytical challenges, from unknown impurities to product failures, by delivering tailored, multi-technique solutions.
Whether you’re dealing with regulatory compliance, novel materials, or confidential IP-sensitive samples, we provide the expertise, technology, and confidentiality required to solve the toughest problems.

Your Challenge	Our Solution
❌ Unknown / Unexpected Impurities Unknown peaks or unexpected contaminants are discovered during testing, with no clear identification method.	✅ Advanced Impurity Identification Use LC-MS, NMR, and multi-technique approaches to identify unknowns, confirm structures, and provide regulatory-ready reports.
❌ No Existing Standard Method Your sample is novel or emerging, and there are no compendial or standard test methods available.	✅ Custom Method Development Develop and validate tailored analytical methods specifically designed for your material or formulation.
❌ Product Failure / Degradation Products degrade, fail, or lose stability during use or storage, causing costly delays or compliance issues.	✅ Root Cause & Failure Analysis Determine degradation pathways, identify failure causes, and provide actionable solutions to prevent recurrence.
❌ Complex Mixture / Multi-Component System Multi-component samples are too difficult to separate, identify, or quantify using routine tests.	✅ Integrated Multi-Technique Testing Combine chromatography, spectroscopy, and advanced separation techniques to fully characterize complex mixtures.
❌ Confidential / IP-Sensitive Projects Your sample or formulation contains highly sensitive intellectual property and requires strict confidentiality.	✅ Secure & Compliant Processes NDA-backed workflows with ISO, GMP, and global regulatory compliance to ensure full protection of your proprietary information.

Our Services

Tailored analytical solutions to solve complex, non-routine challenges — from unknown impurities to method development and failure investigations.

Our laboratory specializes in non-routine analytical solutions for projects that go beyond standard testing. Whether you face unknown impurities, novel materials, product degradation, or multi-component mixtures, we design custom testing strategies using advanced technologies like LC-MS, GC-MS, NMR, and spectroscopy. With deep expertise, rigorous processes, and strict confidentiality, we help you achieve clarity, compliance, and confidence in every result.

Core Services

Impurity & Unknown Identification – Identify and characterize unknown peaks, impurities, and contaminants with LC-MS, NMR, and advanced techniques.
Custom Method Development– Design and validate non-routine analytical methods for novel materials or formulations.
Failure & Root Cause Analysis – Investigate product degradation and performance failures to provide actionable solutions.
Complex Mixture Characterization – Separate, identify, and quantify multi-component or highly complex samples.
Confidential, Regulatory-Compliant Testing – NDA-backed processes aligned with ISO, GMP, and global compliance standards.

Step-by-Step Process

Our streamlined workflow ensures confidentiality, precision, and timely results for every non-routine analytical project.

01. Discovery & NDA

We understand your project goals, sample background, and requirements, while signing an NDA to protect your intellectual property.

02. Feasibility & Scope

Our team evaluates your challenge, selects the right analytical techniques, and outlines a clear testing scope.

03. Proposal & Timeline

You receive a customized work plan, detailed quotation, and clear project milestones for alignment.

04. Sample Intake

Secure handling and documentation of your samples with full traceability and chain of custody.

05. Analysis & Testing

Multi-technique testing using LC-MS, NMR, ICP-MS, spectroscopy, and other advanced instruments.

06. Final Report & Consultation

Delivery of a regulatory-ready report, followed by a consultation to explain results and next steps.

What We Offer

Comprehensive formulation research, comparative studies, and regulatory support to accelerate product development and ensure compliance.

1. Analytical Testing Services

🧩 Impurity & Unknown Identification

Identify and characterize unknown peaks, impurities, and contaminants using LC-MS, NMR, and advanced techniques.

📈 Degradation Product Analysis

Detect and study degradation pathways to ensure product stability and compliance.

🛡️ Complex Mixture Characterization

Separate, identify, and quantify multi-component or highly complex formulations.

2. Method Development & Custom Solutions

🧩 Custom Method Development

Design and validate non-routine analytical methods tailored to your specific needs.

📈 Non-Compendial Method Setup

Develop and optimize methods beyond pharmacopeial standards for emerging or novel products.

🛡️ Method Transfer & Validation

Transfer validated methods to your in-house team and support regulatory submissions.

3. Investigations & Specialized Studies

⚗️ Failure & Root Cause Analysis

Investigate product performance failures and identify degradation or contamination causes.

🛠️ Comparative & Formulation Studies

Compare formulations, competitors, or prototypes for R&D or regulatory purposes.

📜 Confidential, IP-Sensitive Projects

NDA-backed workflows with strict ISO/GMP compliance to protect proprietary data.

Latest Case Studies

Industry & Background:
Discover how our non-routine analytical solutions have helped clients across industries solve complex challenges — from unknown impurity identification to custom method development and product failure investigations.
These real-world cases showcase our multi-technique approach, regulatory compliance, and proven results.

Industry	Challenge	Our Solution	Result
Pharmaceutical	A new drug batch showed unknown peaks during HPLC testing, risking regulatory approval.	Applied LC-MS + NMR to identify the unknown impurity and its degradation pathway, developed a custom non-compendial method for ongoing QC.	Client gained regulatory-ready data within 3 weeks, avoiding costly production delays.
Material Science	A specialty polymer experienced unexplained product failures in field use, causing warranty claims.	Used multi-technique surface and structural analysis (FTIR, SEM, GC-MS) to determine chemical incompatibility with additives.	Identified root cause and provided actionable material change recommendations, reducing failures by 85%.
Biotech	Complex protein mixture could not be separated or characterized with routine methods.	Designed a custom separation workflow with advanced LC-MS/MS and spectroscopy.	Delivered full characterization of all protein components, supporting patent submission and FDA filing.

FAQ

What is non-routine analytical testing, and when should I consider it?

Non-routine analytical testing refers to customized, high-complexity laboratory analysis designed for projects that cannot be addressed by standard or pharmacopeial methods.
It is typically required when:

Your product is new or highly specialized, with no existing test methods.
You encounter unknown impurities, unexpected peaks, or unexplained performance failures.
Routine QC testing fails to provide actionable answers.
Regulatory authorities request non-compendial or investigational data for compliance.

By combining advanced techniques such as LC-MS, GC-MS, NMR, ICP-MS, spectroscopy, and multi-disciplinary expertise, non-routine testing delivers tailored, scientifically defensible results that support R&D, quality control, and regulatory submissions.

How do you protect the confidentiality of my samples and data?

We understand that many of our clients work with proprietary formulations, novel compounds, or sensitive intellectual property (IP). Protecting your confidentiality is our highest priority:

NDA (Non-Disclosure Agreement): Signed before any discussion or sample transfer.
Secure Sample Chain of Custody: All samples are logged, barcoded, and stored in controlled-access facilities.
Data Security: Analytical data is stored on encrypted servers with restricted access.
ISO & GMP Compliance: Our processes meet international regulatory standards, ensuring both confidentiality and traceability.

This rigorous framework allows you to collaborate with confidence, knowing that your innovation is fully protected.

What types of industries do you serve?

Our Complex & Non-Routine Analytical Solutions support a wide range of industries where precision and compliance are critical:

Pharmaceuticals & Biotech: Drug impurity profiling, degradation product studies, protein characterization.
Medical Devices: Material analysis, extractable and leachable studies.
Specialty Chemicals & Polymers: Root cause analysis of product failures, formulation development.
Electronics & Semiconductors: Contamination identification, high-purity material verification.
Food & Beverage: Complex natural product characterization, safety verification.
Environmental & Industrial: Trace contaminant detection, compliance testing.

Our multi-technology platform and cross-disciplinary team allow us to adapt to both regulated and non-regulated industries.

What is the typical turnaround time for non-routine projects?

Turnaround time depends on sample complexity, method development needs, and regulatory requirements:

Simple Investigations: 5–7 business days once samples are received.
Moderate Complexity Projects: 2–3 weeks, including preliminary data review.
Custom Method Development: 3–6 weeks, depending on validation scope and reporting needs.

We always provide a clear timeline in our proposal phase, with milestones for progress updates.
Urgent projects may qualify for expedited analysis, depending on instrument availability and sample readiness.

How do you handle projects where no standard testing method exists?

When no standard method exists, our team specializes in custom method development:

Feasibility Assessment: Evaluate the material, matrix, and regulatory context.
Design Phase: Select appropriate technologies (e.g., LC-MS, GC-MS, spectroscopy).
Pilot Testing: Run initial tests to optimize method parameters.
Validation: Confirm method performance (specificity, sensitivity, accuracy, precision).
Documentation: Deliver a regulatory-ready method package for future use.

This process ensures your unique materials are analyzed accurately and that the data will be accepted by regulatory bodies worldwide.

Can you provide reports suitable for regulatory submissions like FDA or EMA?

Absolutely. Our reporting process follows global regulatory guidelines, ensuring acceptance by agencies such as FDA (U.S.), EMA (Europe), and ICH:

GLP/GMP-Compliant Documentation: Full traceability and audit-ready formatting.
Clear Data Presentation: Chromatograms, spectra, and detailed interpretation.
Non-Compendial Method Justification: When required for novel products.
Certificate of Analysis (CoA): Provided upon request.

This level of documentation helps our clients streamline approval processes, reduce audit risks, and meet the highest industry standards.

How are projects priced, and what factors affect cost?

Pricing for non-routine analytical testing is based on several factors:

Complexity of Analysis: Number of techniques required and sample preparation difficulty.
Scope of Work: Whether it’s a one-time investigation or ongoing monitoring program.
Regulatory Requirements: Additional validation and reporting steps for compliance.
Turnaround Time: Expedited projects may incur rush fees.

We provide transparent, itemized quotations before any work begins, ensuring no surprises.
For long-term clients or high-volume projects, custom pricing packages and annual agreements are available.

How do I get started with a non-routine analytical project?

Getting started is simple and secure:

Initial Consultation: Share a brief description of your challenge via our online form or email (NDA signed before sharing sensitive details).
Feasibility Review: Our scientists assess your requirements and suggest an analytical path.
Proposal & Quotation: You receive a detailed plan, timeline, and cost estimate.
Sample Submission: Secure chain of custody and logged tracking.
Analysis & Reporting: Execution of the plan with progress updates.
Final Consultation: We review results with you and provide recommendations for next steps.

This step-by-step process ensures clarity, confidentiality, and high-quality results every time.

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Address

No. 43, Fukang Road, SHENZHEN, CN

Call Us

+86 0755 28502380

Email Us

sales@uhplcs.com

Complex & Non-Routine Analytical Solutions for Unique Testing Challenges

- When standard tests aren’t enough, our advanced laboratory delivers tailored, non-routine analytical solutions to identify unknowns, impurities, and failure causes.