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ANI GLOBAL SOURCE IS A CULTURE OF INTEGRITY

Analytical Services


As a speciality CDMO, ANI Global Source has a full service analytical capacity that supports your late stage development programs and commercial products.

Science in pursuit of precision

Our scientists at ANI Global Source have years of experience using advanced analytical equipment to ensure precision during all our quality control testing procedures. Our facility is fully equipped with modern chemistry and microbiology laboratories that operate beyond cGMP standards. 

Everything we do analytically is integrated into our core activities. We have a structured approach that enables us to develop challenging methods for you, whether you are in need of method validation, development or transfer, using ICH guidelines. We will work to understand exactly where you are in your program and your unique needs. Whether you are working with development labs, or bringing a product to life from paper tech transfer, are in need of a stability protocol, we will make the process comprehensive and streamlined for you. 

When working with USD methodology, our team strives to understand your quality and risk profile and determine how extensive the need is for verifications and validations done for your USP. At ANI Global Source, we customize our support for you to meet exactly what your product needs. 

Laboratory Testing Services

  • Quality control (chemistry and microbiology)
  • Stability testing and ICH-compliant stability chambers
  • Analytical method development, validations and transfer
  • USP, EP, BP compendial chemistry testing
  • Non-compendial testing
  • Cleaning validation
  • Process and packaging validation
  • Environmental monitoring
  • Microbial testing

Quality Control Testing Equipment

  • Fully equipped chemistry and microbiology laboratories
  • HPLC (conductivity, UV/DAD & RI detectors)
  • Spectrophotometers (UV/VIS, IR)
  • Gas Chromatography (GC-FID)
  • USP Dissolution apparatus type 1 & 2

Stability Testing Capabilities

  • ICH compliant stability programs
  • Room temperature and accelerated chambers
  • 25°C/60%RH
  • 30°C/65%RH
  • 40°C/75%RH
  • Validated, alarmed and on backup power
  • Photostability

 

This links to a page “learn more about our capabilities “- takes us to the contact us/download a brochure page. http://www.wellspringcmo.com/resource-center/wellspring-information-brochure?hsCtaTracking=7cc79dcc-7891-4cdf-a728-3e3619046252%7C0324d9d4-d176-4760-9c85-dd4495bda306


 

Facilities & Equipment
Specialized Product  Manufacturing Capabilities
Manufacturing & Packaging
Analytical Services
Formulation Development
Technology Transfer