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Method Development and Validation

We provide GLP and cGMP Method Development and Validation Specific to Your Sample and Business Needs

Method Development and Validation:
Method Development and Validation is a systematic process that confirms the validity of the analytical procedures employed during the analytical testing of materials or products by confirming the performance capabilities of these analytical methods.
Criterion Scientific can leverage decades of real world industry experience in novel analytical method development and validation. We have state of the art advanced instrumentation and testing facilities that can provide quick, cost effective and accurate results. We perform method development and validation as per your protocol/SOP in accordance with FDA or ICH guidelines.

Need for Method Validation:
Method validation is important to verify that its performance data is substantially accurate to be used in solving a particular analytical problem. Method validation is applicable in the following situations:

  • A new method has been developed

  • An existing method has resulted in new or reframed problems

  • QC audits indicate that an established method is changing with time

  • To show the equivalence of two methods


Typical Method Validation Elements Include:
  • Accuracy

  • Precision / Reproducibility

  • Limit of detection

  • Robustness

  • Limit of quantitation

  • Linearity

  • Range

  • Ruggedness

  • Specificity



Method Development and Validation Applications:
Criterion Scientific develops complex methods and testing protocols including following:
  • Pharmaceutical Analysis and Method Development

  • Drug Development, Pharma Products and Medical Devices

  • Bioanalytical Services and Method Development and Validation

  • LC-MS Method Development

  • LC-MS Method Validation

  • Bioassays and their Method Development & Validation

  • Quality Control and Method Development & Validation

  • Biopharmaceutical Analysis and Development

  • cGMP Release Testing



Analytical Techniques used for Method Development & Validation:
  • Gas Chromatography / Mass Spectrometry (GC/MS)

  • Liquid Chromatography / Mass Spectrometry (LC/MS)

  • Dynamic Headspace Concentration GC/MS

  • High Pressure Liquid Chromatography (HPLC)

  • Gel Permeation Chromatography (GPC or SEC)

  • Fourier Transform Infrared Spectroscopy (FT/IR)

  • Inductively Coupled Plasma Spectroscopy (ICP-OES/MS)

  • Secondary Ion Mass Spectrometry (SIMS)

  • NMR Spectroscopy Analysis



cGMP Quality Control Laboratory Analysis:
Criterion Scientific provides cGMP Quality Control (QC) lab testing and analysis for raw materials, excipients, APIs and GMP release testing for pharmaceutical and drug industries.
  • Excipient and raw material analysis

  • Finished and Semi finished product testing and analysis

  • GMP batch release testing

  • Stability Studies

  • Formulation and deformulation studies

  • Chemical analysis

  • Degradation studies

  • Pharma and drug research and development


Related Services:-

Surface analysis services


Polymer analysis services


Failure analysis services


Corrosion analysis services


Contact us to find out how chemical analysis labs at Criterion Scientific can add value to your business!!

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Software application development factsheet © 2013-2014 Criterion Scientific LLC.
SITEMAP
Founded:2010
Offices:USA and India
Industries:Automotive Industries, Aerospace and Defense Industries, Medical Device Industries, Polymer Industries, Consumer Product Industries, Construction Industries, Electronics and Semiconductor Industries and Manufacturing Industries.
Services:Analytical testing labs, Materials Analysis Services, Chemical analysis services, Mechanical testing services, Plastic testing, Failure analysis services, Corrosion analysis, Microstructure analysis
Technologies: SEM-EDX, TEM, XPS-ESCA, FT-IR,OM, UTM, ICP, GCMS, LCMS. DSC, TGA, TMA
Enterprise Skills:Materials Testing & Analysis Services Competitor Product Analysis Services
Industry Partnerships:Privately Owned Company
Clients:Clients from all industrial sectors including Automotive Industries, Aerospace and Defense Industries, Medical Device Industries, Polymer Industries, Consumer Product Industries, Construction Industries, Electronics and Semiconductor Industries and Manufacturing Industries