Analytical Testing and Formulation Development

Analytical Testing and Formulation Development
Product Description

Quality Chemical Laboratories is known for its capabilities in the development and validation of analytical methods for raw materials, drug substances, and drug products. With a strong focus on quality and precision, QCL employs cutting-edge technologies and a highly skilled team of scientists to offer comprehensive analytical services.

QCL possesses significant expertise in the analysis of raw materials used in pharmaceutical manufacturing. They develop and validate analytical methods to assess the quality and purity of raw materials, ensuring their compliance with established standards and specifications. QCL’s capabilities extend to testing excipients, packaging materials, and other components critical to the production of pharmaceutical products. This comprehensive approach enables pharmaceutical companies to maintain control over the quality of their raw materials and safeguard the integrity of their finished products.

Quality Chemical Laboratories

  • US
  • 2019
    On CPHI since
  • 3
    Certificates
  • 250 - 499
    Employees
Company types
Biopharmaceutical company
CMO/CDMO
Contract Service
Manufacturer/Innovator
Pharmaceutical company
Primary activities
Analytical Services
Biopharmaceutical
Contract Manufacturer
Generic APIs producer
Laboratory Services
Pharmaceutical Company (generic finished products)
Pharmaceutical Company (innovator finished products)

Quality Chemical Laboratories

  • US
  • 2019
    On CPHI since
  • 3
    Certificates
  • 250 - 499
    Employees
Company types
Biopharmaceutical company
CMO/CDMO
Contract Service
Manufacturer/Innovator
Pharmaceutical company
Primary activities
Analytical Services
Biopharmaceutical
Contract Manufacturer
Generic APIs producer
Laboratory Services
Pharmaceutical Company (generic finished products)
Pharmaceutical Company (innovator finished products)

Quality Chemical Laboratories resources (1)

  • Whitepaper Rapid, Science-Driven Success in Early Phase Pharmaceutical Development

    THE CHALLENGE: Develop at least one dosage form that avoids first-pass metabolism in the gut and all analytical methods using a limited quantity API. THE STRATEGY: This program began with typical quality by design elements including excipient compatibility studies and API characterization allowing formulations development personnel to select the right excipients for initial prototype development. In fact, one excipient caused an API stability problem. Since the excipient compatibility study design was binary, the stability issue was easily isolated to a single excipient and eliminated from future formulation inclusion.