Address: 45-1 Ramsey Road, Shirley, NY 11967, USA    USA: 1-631-559-9269  1-631-448-7888   Fax: 1-631-938-8127  Europe: 44-207-048-3343   Email: info@creative-biomart.com
Inquiry now !
* E-mail Address:
* Service & Products Interested:
Project Description:
* Verification code:
Please input "biomart" as verification code.
Submit

SERVICES
Your Position:  Home >> Services >>Pharmaceutical Stability Analysis

Pharmaceutical Stability Analysis

Share

The stability of proteins is a critical factor in their manufacture, storage and use. Creative BioMart provides a complete range of ICH stability conditions and cGMP test methods to assure the accurate profile of your biopharmaceutical product during all stages of drug development, from early research & development to commercial or post approval studies. Our stability testing service provides essential data on how the quality of a pharmaceutical varies over time under the influence of different environmental factors such as temperature, humidity, photostability, cycling and freeze/thaw. Custom storage conditions are available to support your specific procedures and timelines—whether you require storage only, temperature, humidity, photostability, cycling and freeze/thaw and testing, testing only, and/or project management assistance. Plus, stability reports can be tailored to meet your needs.

Creative BioMart is integrated within the laboratory testing complex and provides following services:

Service Items:

  • All temperature and humidity conditions needed to comply with ICH guidelines
      • 75% relative humidity/40°C
      • 60% relative humidity/25°C
      • Ambient humidity/25°C, 30°C, 40°C, 50°C, 55°C
      • Refrigeration at 5°C
      • Freezer at -20°C and -80°C
      • Liquid nitrogen
  • A Alternate custom conditions can also be created;
  • Forced degradation study;
  • Freeze/thaw study;
  • Photostability study;
  • Mechanical stress;
  • Container compatibility;
  • In-use studies (IV bags, infusion pumps, etc.);
  • Drug-substance stability testing;
  • Accelerated stability;
  • Long-term stability.

Stability Analysis Techniques:

  • Gel Electrophoresis;
  • Western blot;
  • ELISA/Immunoassays;
  • Isoelectric focusing;
  • Capillary electrophoresis;
  • Amino-acid analysis;
  • Chromatography and Mass Spectrometry;
  • Immunochemistry techniques;
  • Dynamic light scattering (DLS);
  • Far- and near-UV circular dichroism spectroscopy;
  • Fluorescence spectroscopy;
  • Differential scanning calorimetry (DSC);

Our pharmaceutical testing applies specialized knowledge to increase your competitive advantage. Creative BioMart's pharmaceutical stability testing services supply numerous benefits:

  • Receive quicker regulatory approvals;
  • Get high-quality testing customized to your requirements;
  • Save costs;
  • Reduce or eliminate risks;
  • Get rapid, reliable turnarounds;

Request more information to see how Creative BioMart can help you with Pharmaceutical Stability Analysis.

Welcome to contact us or send an email to info@creative-biomart.com for project quotations and more detailed information.
45-1 Ramsey Road, Shirley, NY 11967, USA
USA: 1-631-559-9269  1-631-448-7888
Europe: 44-207-048-3343
FAX: 1-631-938-8127
EMAIL: info@creative-biomart.com

facebook twitter linkedin google plus google plus

Join 10 other subscribers

24x7
CUSTOMER SERVICE
Easy access to products and services you need from our library via powerful searching tools
Copyright © 2007 - 2017 Creative Biomart. All Rights Reserved.