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Method Development & Validation

Developing Methods That Work in Your Lab—Not Just Ours

Quantum Analytics Group develops, remediates, optimizes, validates, verifies, and transfers analytical methods for pharmaceuticals, cosmetics, personal-care products, raw materials, and complex specialty products.

Whether you need a new stability-indicating method, an existing procedure is producing inconsistent results, or a method has failed transfer, you work directly with experienced scientists who identify the underlying cause and develop a fit-for-purpose solution that performs reliably in the real world.

 

REGULATORY
SERVICES
CASE STUDY

Complete Analytical Method Development Expertise

 checkmark  New analytical method development

 checkmark  Method optimization and refinement

 checkmark  Stability-indicating method development

 checkmark  Method validation and verification

 checkmark Method remediation and troubleshooting

 checkmark  USP <1224> Method Transfer

 checkmark USP <1226> Compendial Verification

 checkmark  USP <1224> Method Transfer

 checkmark  Forced degradation study design

 checkmark Regulatory-response support

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CHOOSE THE SUPPORT YOU NEED

Method Support Matched To Your Actual Problem

Start with a defined project or an analytical challenge that still needs to be diagnosed. Quantum can support the procedure from initial feasibility through implementation and transfer.  Our scientists work collaboratively with your team, helping you retain control while adding specialized expertise where it matters most. 

Develop a New Method

Build a fit-for-purpose procedure for identity, assay, potency, purity, impurities,contaminants or stability testing.

Optimize or Remediate

Investigate poor recovery, inconsistent precision, matrix interference, insufficient sensitivity, long run times, or recurring method failures.

Validate or Verify

Generate documented evidence that an analytical procedure is suitable for its intended use and required performance

Transfer Successfully

Prepare and support transfer into an internal QC laboratory, manufacturing site or another contract laboratory.

SCOPE OF SERVICE

A complete analytical method lifecycle

Analytical Applications

checkmark Assay and potency

checkmark Identity

checkmark Purity

checkmark Related Substances

checkmark Degradation Products

checkmark Trace Impurities

checkmark Stability Indicating

checkmarkRaw Material & Excipient       Testing

Lifecycle Services

checkmark  Feasibility Assessment

checkmark  New Method 

           Development

checkmark  Method Optimization

checkmark  Method Remediation

checkmark  Method Qualification

checkmark  Full or partial VAlidation

checkmark Compendial Method

     Verification

checkmark Revalidation and Transfer

Validation Characteristics

checkmark Accuracy

checkmark Repeatability

checkmark Intermediate Precision

checkmark Lineraity and Range

checkmark Specificity and Selectivity

checkmark Detection and Quantitation Limits

checkmark Robustness

 checkmark System Suitability

checkmark Sample and Standard Stability

REQUEST A QUOTE
REGULATORY AND COMPENDIAL FRAMEWORK

Science-based development designed around intended use, scientific risk, and fit-for-purpose validation

Quantum Analytics Group method development and validation services are designed around the analytical target, the method's intended use, product development stage, analytical risk, transfer requirments, and applicable regulatory or compendial expectations.

Development and Validation

  ICH Q14, Analytical Procedure Development

  ICH Q2(R2), Validation of Analytical Procedures

  Applicable FDA and CDER anlytical method guidance

  Client-defined quality and acceptance requirements

Transfer and Verification

  USP<1224>, Transfer of Analytical Procedures

  USP<1226>, Verification of Compendial Procedures

  Applicable USP-NF monographs and General Chapters

  Predefined laboratory acceptance and equivalency criteria

Stability-Indicating Methods

  ICH Q1A(R2), StabilityTesting of New Drug Substantances and Products

Stress testing and forced degradation study design

Evaluation of degradation pathways and analytical specificity

Fit-For-Purpose—Not One-Size-Fits-All

Not every project requires every study or validation characteristic. Before work begins, Quantum works with the client to define intended use, performance requirements, acceptance criteria, documentation, and applicable regulatory or compendial considerations. 

PROJECT DELIVERABLES

Clear documentation your team can use

The final method development/validation/verification documentation should be defined during project scoping. Depending on the engagement, deliverables may include:

Project scope and analytical development plan

Analytical target profile or performance requirements

Development experiments and scientific rationale

Final analytical procedure

Validation or verification protocol

Predefined acceptance criteria

 

System-suitabiliy requirements

Raw and processed data

Statistical analysis

Final development and validation reports

Method tranfer protocol and report

Technical consulting during implementation

CASE STUDY: API METHOD TRANSFR AND COMPARISION

Helping an API manufacturer respond to FDA questions with the right data

When the FDA questioned an in-house method used for a well-known generic antibiotic API, the manufacturer need more than laboratory testing. It needed a defensible transfer protoocol, a comparative study against the then current USP monograph method, and guidance on presenting the requested information without creating unnecessary regulatory questions.

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The Regulatory Challenge

The manufacturer had submitted supporting data for its in-house HPLC-UV impuritymethod as part of an ANDA. Upon review, the FDA requested additional data, including a side-by-side comparison with the USP method to demonstrate equivalance.

The Technical Complication

The USP procedure used a dual-electrode coulomeric detector. This electrochemical techniques can be sensitive to electrode deterioration, fouling, temperature changes, mobile-phase impurities, and electoactive contamination within the chromatography system.

Quantum's Assignment

Quantum was recommended as a resource with experience in complex and unusual analytical methodologies. Quantum's team was asked to generate the necessary comparative data and guide the supporting submission work.

A controlled, fit-for-purpose approach

Rather than producing a larger volume of data than the agency had requested, Quantum focused the program on specific evidence needed to answer the FDA's questions. This reduced the risk that unnecessary information would introduce additional issues or complicate the response.

Method transfer first

Quantum developed a formal protocol to transfer the client's HPLC-UV method into our own laboratory. The protocol defined:

  • Expected method performance
  • Aceptance criteria for each participating laboratory
  • Equivalence criteria between the originating and receiving laboratories
  • The evidence (supporting data) required before beginning the comparative study.

Why the transfer mattered

A comparison between two methods is only meaningful when the client method has first been shown to perform reproducibly in the receiving laboratory. By establishing transfer acceptance and laboratory-equivalence criteria, Quantum created a defensible foundation for the subsequent USP comparison.

After successful transfer, Quantum performed the side-by-side evaluation of the client's HPLC-UV procedure and the USP coulometric method.

 

Outcome

The manufacturere received a structured method-transfer package and the comparative analytical data needed to address the FDA request. 

Business value

Quantum helped the client protect its production timeline by translating a regulatory question into a focused analytical program rather than an open-ended testing excercise.

Quantum advantage

The engagement combined analytical method transfer, complex detector expertise, comparison-study design, predefined equivalence criteria, and practical regulatory-response support.

GET STARTED

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Bring Clarity to Your Product Challenges

Have a product, method, analytical or testing issue? Schedule FREE consultation with our team by submitting the form on this page. We’ll discuss your challenges, walk you through potential testing strategies, and help you move forward with confidence.

Address:
11 Deerpark Drive, Suite 104

Monmouth Junction, NJ 08852

Corp & Admin Offices:

30 N Gould Street Suite 10683
Sheridan, WY 82801 USA

 

Call: (800) 448-2968

Email: info@quananalytics.com