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)
Aurigene Pharmaceutical Services is
one of the leading contract research organization (CRO)
provides the best contract research manufacturing
You are about to leave Aurigene Pharmaceutical Services and affiliates website. Aurigene Pharmaceutical Services assumes no responsibility for the information presented on the external website or any further links from such sites. These links are presented to you only as a convenience, and the inclusion of any link does not imply endorsement by Aurigene Pharmaceutical Services.
If you wish to continue to this external website, click Proceed.
Leaving already?
Don't forget to join us at
CPHI Worldwide 2023.
October 24th-26th, 2023 | Barcelona, Spain
Get ready to accelerate your drug’s journey to the market