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Analytics

Accurate and precise analytical results
when you need them.

ROPACK PHARMA SOLUTIONS’ EXPANDED ANALYTICAL CAPABILITIES SUPPORT YOUR SOLID ORAL DOSAGE PROJECT AT EVERY STAGE OF DEVELOPMENT.

From early strategic investigative work on possible formulations to the development and implementation of methods and the generation of regulatory submission data, our team of experienced scientists will work – and communicate – with you at every step. We offer preform, drug characterization, method development, validation and stability testing services to meet your challenging analytical needs and timelines in a cGMP-compliant laboratory.

PREFORMULATION

formulation_devFollowing an agreed-upon formulation strategy, we perform preformulation studies to generate data that will lead to the key valuation milestones for your drug candidate. These studies may include the characterization and determination of the following:

  • Excipient compatibility
  • Forced degradation studies
  • Polymorph screenings
  • Physicochemical properties
  • Particle size morphology
  • Alternate formulation evaluation
  • Packaging evaluation studies 
DRUG CHARACTERIZATION

drug_charIn today’s age of QbD, an early understanding of the physiochemical properties of drug substances, excipients and finished products is crucial. Through the use of advanced analytical testing systems, Ropack Pharma Solutions provides strategies for the optimization of your drug product development.

  • Evaluation of quality attributes
  • API qualification
  • Assessment of lot-to-lot variability
  • Assistance in quality investigations and CAPAs
METHOD DEVELOPMENT AND VALIDATION

method_devOur cGMP lab performs method development and validation for a broad spectrum of pharmaceutical compounds and dosage forms during various drug development stages, including methods for:

  • Chromatography techniques (HPLC, UPLC, GC)
  • Stability-indicating assay and/or related substances methods for API and drug products
  • Dissolution
    • Immediate release
    • Controlled release (ER, MR, DR, SR)
  • Cleaning residual methods
ANALYTICAL RELEASE TESTING

analytical_relWe can support your product through its lifecycle from pre-IND to commercial product, including routine analysis such as CTM release and stability testing. 

  • API and finished product release testing
  • Clinical supply release testing
STABILITY TESTING

stability_testingICH-compliant stability storage temperatures and, where applicable, humidity control, with many intermediate options available.

  • Ambient and accelerated stability at various temperatures and durations, in accordance with relevant ICH guidelines
  • Photostabilty
  • Thermal cycling
  • Comparator product

THE ROPACK PHARMA SOLUTIONS ADVANTAGE

Ropack Pharma Solutions is committed to be your trusted manufacturing and packaging partner. Outsource your pharmaceutical or nutraceutical products to us with confidence.

  • A unique International Serialization Hub
  • 400+ cGMP cold storage locations
  • cGMP-compliant facilities totaling more than 241,000 sq. ft.
  • Temperature- and humidity-controlled facilities
  • Three level 9 security vaults with biometric access for controlled substances
  • Controlled substance management
  • Dedicated project manager