Shelf Life & Stability Studies

Stability studies involve developing a preparation of the drug which is both stable and acceptable to the patient and are essential for drug product marketing approval.Stability studies are conducted at all phases of the drug development cycle for different purposes with the ultimate goal of having a stable product on the market.  During development, stability studies are conducted to support the formulation development and safety and efficacy claims of investigational new drugs.  At registration, they are conducted to ascertain the quality and shelf-life of the drug product in their intended packaging configuration.  After approval, the stability studies are conducted to ensure the quality of production and to support site or other changes to the product.

The global revenue for advanced drug delivery systems is estimated to be $151.3 billion in 2013. In 2018, revenues are estimated to reach nearly $173.8 billion, demonstrating a compound annual growth rate (CAGR) of 2.8%. Europe contributed about 27% of the total drug delivery market in 2010 and was $36 billion. BCC expects this market to grow to $49 billion by 2016 at a CAGR of 5.6%. The global generics sector reached $269.8 billion in 2012. This sector is expected to reach $300.9 billion in 2013 and $518.5 billion in 2018, with a compound annual growth rate (CAGR) of 11.5%.

Stability studies of pharmaceuticals to identify impurities and degradation. We offer stability storage and testing that adheres to International Conference on Harmonization (ICH) guidelines. Standard storage conditions include frozen (ultra cold and -20°C), refrigerated (5°C), ambient (25°C/60% relative humidity), intermediate (30°C/65% relative humidity), and accelerated (40°C/75% relative humidity). Custom storage conditions and specialized climatic zone considerations can also be accommodated.

The global revenue for advanced drug delivery systems is estimated to be $151.3 billion in 2013. In 2018, revenues are estimated to reach nearly $173.8 billion, demonstrating a compound annual growth rate (CAGR) of 2.8%. Europe contributed about 27% of the total drug delivery market in 2010 and was $36 billion. BCC expects this market to grow to $49 billion by 2016 at a CAGR of 5.6%. The global generics sector reached $269.8 billion in 2012. This sector is expected to reach $300.9 billion in 2013 and $518.5 billion in 2018, with a compound annual growth rate (CAGR) of 11.5%.

  • Storage
  • Stability Testing and Analysis (HPLC, LC/MS, GC)
  • Forced Degradation Studies
  • Sterility / Microbiological Assessment

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