LC-MS/MS Analytical Services for Bioanalytical Excellence

Alturas Analytics provides LC-MS/MS services that help organizations make confident decisions during all stages of drug development. Our LC-MS/MS platforms generate precise and reliable submission-ready data for small-molecule and complex therapeutic programs during all stages from early-stage assay development to regulated clinical sample analysis.

Our quantitative expertise prepares your data for regulatory review when you are developing new chemical entities.

Comprehensive LC-MS/MS Services from Discovery Through NDA

Our scientists assist your project throughout feasibility evaluation, formal method validation, and clinical execution. The LC-MS/MS services at Alturas include:

• Custom method development and validation aligned with global guidance
• Trace-level quantitation of drug compounds, metabolites, and biomarkers
• High-throughput sample preparation for consistent results
• Incurred sample reanalysis (ISR) and full data integrity assurance

Learn More: Development and Validation of LC-MS/MS Methods

Expertise Across Molecules and Modalities

The laboratory at Alturas Analytics provides analytical support for various biological samples and chemical compounds. We provide:

• Assay support for small molecules, peptides, and biologics
• LC-MS/MS-based workflows that adapt to high-complexity studies

Our team demonstrates exceptional ability to handle extraction variations and method transfers between development and regulated environments.

Instrumentation and Platform Capabilities

Our lab uses industry-standard instrumentation configured for accuracy, precision, and throughput.

Explore Our Tech Focus: Alturas Analytics Instrumentation

Regulatory Compliance and Method Validation

Alturas Analytics operates under GLP compliance and follows ICH M10 guidance for method validation and data reporting procedures. We offer:

• Selectivity, sensitivity, accuracy, and reproducibility assessments
• Audit-ready documentation for regulatory agencies

Explore More: Alturas Analytics Quality

Why Alturas for LC-MS/MS Services

• Dedicated study leads and regulatory support
• Proven success supporting INDs, NDAs, and global submissions
• Seamless integration with PK/TK and method development workflows

Related Project: GC-MS/MS Tuberculosa Case Study

HRMS/MS

Our HRMS capabilities support both qualitative and quantitative workflows—ideal for protein quantitation, metabolite identification, biomarker discovery, and non-targeted screening delivering precise mass accuracy and robust sensitivity to provide deeper insight across discovery and regulated studies.

GC-MS/MS Analytical Services for Specialized Detection

The GC-MS/MS technology at Alturas Analytics delivers sensitive and selective detection methods for detecting volatile semi-volatile and thermally unstable compounds. Scientists from our team employ GC-MS/MS techniques when LC-MS/MS methods are inappropriate to achieve complete detection of substances across therapeutic programs.

GC-MS/MS services at Alturas include:

• Quantitative analysis of volatile and semi-volatile organic compounds
• The method detects trace amounts of impurities alongside metabolites and biomarkers in samples.
• The method supports testing samples from plasma urine breath and tissue extracts across different matrices.
• Specialized workflows for environmental and stability-related studies
• Our team performs GLP-compliant method development and validation according to regulatory guidance.

GC-MS/MS Applications:

• The analysis of low molecular weight drugs and their metabolites falls under this category
• Chiral separations and impurity profiling
• Biomarker validation and metabolic pathway studies

Why GC-MS/MS with Alturas?

• The expanded capabilities enable the analysis of compounds that are not suitable for LC-MS/MS procedures.
• The company possesses a successful history of regulatory submissions that require GC-MS/MS data collection.
• The combination of LC-MS/MS with PK/TK workflows along with this method provides complete bioanalytical support.

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Quantitative Analysis of Cotinine in Human Plasma and Urine Utilizing a Simple Supported Liquid/Liquid Exchange Extraction and GC-MS/MS

Request an LC-MS/MS Project Consultation

Need defensible, fast-turnaround LC-MS/MS support for your drug development program?

The first step to start a data-driven partnership with an Alturas Analytics scientist begins with requesting a consultation.

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Bioanalytical Services

PK/TK Service

Method Development and Validation