Analytical Development

Analytical Development

Products
Analytical Development
Analytical Development

Information

BioDuro-Sundia's Analytical Testing team offers high quality analytical services including method development and validation, qualification of reference standards, testing and release studies, stability studies, and CMC dossier preparation services. Drug Substance cGMP Compliant Method Development & Validation Starting materialsIntermediatesAPIsQualification of reference standardsAPI Characterization Physical propertiesImpurities identificationStructure elucidation & confirmationChemical characterizationAPI Testing & Release Drug Substance specification support Analytical support for Formulation Development Stability Management & Testing (according to ICH/FDA/CFDA guidelines) Stability indicating method validation & transferPreparation & Approval of stability protocolSample managementSample testingData & trend analysis & preparationanalytical training, documentation & internal auditStability Conditions include 20C5C25C/60%RH30C/65%RH30C/60%RH40C/75%RH50CPhotostabilityDrug Product Method Evaluation Development & Optimization Method Transfer & Validation Drug Product specification & Support Stability Studies Siemens APOGEE Monitoring SystemFull generator backupDrug product, drug substance, placeboTesting Capabilities: XRPD; Dissolution; Karl FisherDrug Product Testing & ReleaseAssay/impurities testing & method validationDissolution testing and method validationBlend/content uniformity testing & method validationCleaning verification/validationProtocol designLong term stab...
Service Categories
  • Laboratory and Analytical Services
    Distribution Areas
    OceaniaEast Asia (e.g. China, Japan, Korea)Europe - EU countriesSouth America (e.g. Brazil, Colombia)
    BioDuroBioDuro, an Advent portfolio company, is a CRDMO with a 30-year proven track record. Headquartered in Irvine, California, BioDuro employs more than 2,000 scientists with deep expertise in small- and large-molecule discovery, development, and manufacturing. We provide fully integrated drug discovery services spanning chemistry, biology, and pharmacokinetics (DMPK), along with comprehensive IND-enabling capabilities, including both drug substance and drug product development.

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