Analytical Services

Analytical Services
Product Description

• Method Development & Validation • Release Testing • Reference Standard Qualification • Compendial Testing (USP / EP / BP / JP) • Characterization (XRPD, NMR, FTIR) • Chiral Separations • Particle Size Analysis • Elemental Impurities (ICP-MS) USP <232>,<233>, ICH Q3D • Impurity Identification (GC-MS & High-Resolution, Accurate-Mass LC-MS/MS) • ICH Stability & Storage inclusive of Photostability & Forced Degradation • Forced Degradation • Nitrosamine Analysis • Dissolution USP <711> • Particulate Matter USP <788>, <789>

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SK pharmteco

  • US
  • 2022
    On CPHI since
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Primary activities
Analytical Services
API Producer
Chemical Development
Contract Manufacturer
Custom Manufacturing/Custom Synthesis
Fine Chemicals Company
Intermediates Manufacturer
Laboratory Services
View company profile

SK pharmteco

  • US
  • 2022
    On CPHI since
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Primary activities
Analytical Services
API Producer
Chemical Development
Contract Manufacturer
Custom Manufacturing/Custom Synthesis
Fine Chemicals Company
Intermediates Manufacturer
Laboratory Services
View company profile

SK pharmteco resources (1)

  • Empowering API Manufacturing: Perspectives From a Contract Development and Manufacturing Organization

    Video Empowering API Manufacturing: Perspectives From a Contract Development and Manufacturing Organization

    As a Contract Development and Manufacturing Organization (CDMO), navigating the landscape of EU API manufacturing presents critical challenges and opportunities. In response to Cefic’s November 2023 recommendations, CDMOs have an important role to play to foster sustainable growth, support reshoring initiatives, and drive innovation investment to prioritize supply security and social-environmental standards. The decline in EU-based API production underscores the urgency to address competitive pressures from global markets and EU regulatory dynamics. This presentation examines the implications for CDMOs, offering insights into strategies to strengthen API manufacturing capabilities, enhance global competitiveness, and contribute to healthcare resilience.
    2024-10-23