Drug Product Characterization Studies and Testing

Our characterization services for NCEs, generics and first generic help assess the quality characteristics of drug product like physical and chemical properties, which are primary elements to ensure the desired quality, taking into account the safety and efficacy of the drug product. We help to understand physical, chemical, biological and microbiological properties or characteristic that should be within an appropriate specification to ensure the desired product quality.

We also provide services for 505(b) 2 applications.

The following services are available at both lab and pilot scales at various drug product stages:

Physical Attributes:

• Appearance
• Size
• Score configuration
• Friability

Chemical parameters:

• Identification
• Water Content/LoD
• Polymorphic form identification
• Content Uniformity
• Assay
• Dissolution
• Degradation Products/Organic impurities
• Chiral purity
• Residual Solvents
• Elemental impurities
• Nitrosamine impurities
• Microbial limits/Sterility (as applicable)