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Our characterization services for NCEs, generics and first generics help assess the quality characteristics of drug products such as 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 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)

Aurigene Pharmaceutical Services is

one of the leading contract research organization (CRO)

provides the best contract research manufacturing

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