Uncompromising Quality Assurance

At NeoPeptix, quality is integral to every step of our peptide synthesis process. Our rigorous quality control ensures every batch meets the highest standards for purity, identity, and consistency.

>99%

Average Purity

100%

Identity Confirmation

<0.1%

Impurity Levels

100%

Batch Documentation

Our Quality Standards

Comprehensive quality control at every stage of production

Raw Material Testing

All starting materials undergo rigorous identity and purity verification before use in synthesis.

In-Process Controls

Continuous monitoring and testing throughout synthesis to ensure reaction completion and purity.

Purification Standards

Multiple purification steps including HPLC to achieve >95% purity for all standard peptides.

Analytical Characterization

Comprehensive analysis including HPLC, MS, and amino acid analysis for identity confirmation.

Documentation

Complete batch records and certificates of analysis for full traceability and transparency.

Stability Testing

Long-term and accelerated stability studies to ensure product integrity over time.

Quality Control Process

Our comprehensive approach to ensuring product quality and consistency

1

Raw Material Qualification

Verification of all starting materials and reagents against specifications.

2

Synthesis Monitoring

Real-time monitoring and in-process controls during peptide assembly.

3

Purification & Analysis

HPLC purification and comprehensive analytical characterization.

4

Final Release

Quality review and approval before product packaging and shipping.

Analytical Testing Methods

Advanced techniques for comprehensive peptide characterization

HPLC Analysis

Purity Assessment

High-performance liquid chromatography for determination of peptide purity and identification of related substances.

  • Reverse-phase C18 columns
  • UV detection at 214nm & 280nm
  • Gradient elution methods
  • Purity >95% standard

Mass Spectrometry

Identity Confirmation

High-resolution mass spectrometry for accurate mass determination and sequence confirmation.

  • ESI and MALDI-TOF methods
  • High-resolution instruments
  • Mass accuracy <5 ppm
  • Sequence verification

Amino Acid Analysis

Quantitative Composition

Quantitative determination of amino acid composition following acid hydrolysis.

  • Post-column derivatization
  • Ninhydrin detection
  • Composition verification
  • Quantitative accuracy

Solubility Testing

Solution Behavior

Evaluation of peptide solubility in various solvents and buffer systems.

  • Multiple solvent systems
  • pH-dependent solubility
  • Concentration optimization
  • Stability assessment

Water Content

Karl Fischer Titration

Precise determination of water content in peptide samples using Karl Fischer titration.

  • Coulometric method
  • High sensitivity
  • Accurate quantification
  • Batch consistency

Microbiological Testing

Sterility & Endotoxins

Testing for bioburden, endotoxins, and sterility where required for specific applications.

  • LAL endotoxin testing
  • Bioburden assessment
  • Sterility testing
  • GMP compliance

Quality Documentation

Comprehensive documentation for traceability and regulatory compliance

Certificate of Analysis

Detailed analytical report for each batch including purity, identity confirmation, and all test results.

Batch Records

Complete documentation of synthesis, purification, and analytical processes for full traceability.

Quality Manual

Comprehensive quality management system documentation including SOPs and quality policies.

Request Quality Documentation

Contact our quality assurance team to request certificates of analysis, quality manuals, or other documentation.