PEPTIQORE™

COMMERCIAL QUALITY

Reference Material Quality & Handling

PeptiQore analytical reference materials are prepared, characterised and documented for professional analytical use. This page describes our material handling practices.

MATERIAL HANDLING PRACTICES

01

Material Identity

Each material is characterised for identity using appropriate analytical techniques. For peptide reference materials, identity confirmation typically includes LC-MS molecular mass verification and, where applicable, sequence confirmation. Identity characterisation is performed on each production lot.

02

Purification

Reference materials are purified to analytical grade using preparative HPLC or equivalent techniques appropriate to the material type. Target purity is defined per material and confirmed analytically. Purification conditions are documented internally.

03

Characterisation

Characterisation scope is defined per material and may include HPLC purity analysis, LC-MS mass confirmation, MS/MS fragmentation, water content, counterion analysis and other tests relevant to the specific material. Characterisation level is stated on the material record.

04

Lot Documentation

Each commercial lot is accompanied by a Certificate of Analysis (CoA) documenting the analytical results obtained for that specific lot. Additional documentation such as HPLC chromatograms, LC-MS reports and Technical Data Sheets is available as indicated on the material record.

05

Storage

Storage conditions are defined based on material stability characteristics. Recommended storage conditions are stated on the material record and CoA. Materials are stored under defined conditions prior to dispatch.

06

Traceability

Internal lot records link each commercial material to its production, purification and characterisation data. This supports traceability from the commercial material back to the analytical evidence.

07

Custom Material Preparation

Custom impurity reference materials are prepared following technical review and project confirmation. Scope, characterisation level and documentation package are agreed with the customer prior to production. Custom materials follow the same quality practices as standard catalogue materials.

CHARACTERISATION

Characterisation Levels

Level 1

Identity + Purity

  • LC-MS mass confirmation
  • HPLC purity analysis
  • Certificate of Analysis

Level 2

Enhanced Analytical

  • All Level 1 deliverables
  • MS/MS fragmentation data
  • HPLC chromatogram report
  • Technical Data Sheet

Level 3

Full Characterisation Package

  • All Level 2 deliverables
  • Water content
  • Counterion analysis
  • Additional tests as agreed
  • Full analytical report

PeptiQore does not claim formal accreditation, GMP certification or pharmacopeial certification unless explicitly stated for a specific material or service. Material characterisation is performed for analytical reference purposes. Users are responsible for evaluating fitness for their specific application.

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