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Parenteral drug development & stability testing

Recipharm’s state-of-the-art parenteral facilities offer integrated product development and sterility testing to support the development and the approval of injectable drugs for most region in the world. Our early phase capabilities help pharmaceutical and biotech companies accelerate timelines, reduce risk, and ensure a smooth transition to GMP manufacturing.  

Whether you are developing generics, NCEs or proof-of-concept injectables, we support robust formulation design across solutions, suspensions, and lyophilised powders. Our scientists apply Quality by Design (QbD) principles and proven technical expertise to optimise formulations for clinical success.

Our formulation development capabilities include:

  • Solubility profiling, pH stability, and excipient screening
  • Custom design of isotonic, buffered, and co-solvent-based formulations
  • Feasibility batches for solutions, suspensions, and lyophilised products
  • Scientific approach using ReciPredict
  • Lab-scale mixing, filtration, and freeze-drying cycle optimisation
  • Accelerated and long-term ICH stability studies
  • Compatibility assessments for vials, ampoules, stoppers, and delivery systems
  • Tech-transfer into a GMP facilities


Sterility and analytical testing includes:

  • Pharmacopoeia testing
  • Method development and validation
  • Stability testing
  • Validated sterility and endotoxin testing
  • Viable and non-viable particulate analysis
  • Extractables, leachables, nitrosamine, and container closure integrity testing


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Partner with Recipharm for your parenteral drug development services

From formulation design to clinical readiness, Recipharm offers the technical foundation for safe, scalable injectable product development with our parenteral development and stability testing services. Contact us to discuss how we can support your next project.
 

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