Analytical Development

Analytical Development
Product Description

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 materials
  • Intermediates
  • APIs
  • Qualification of reference standards
API Characterization
  • Physical properties
  • Impurities identification
  • Structure elucidation & confirmation
  • Chemical characterization
API Testing & Release

Drug Substance specification support

Analytical support for Formulation Development

Stability Management & Testing (according to ICH/FDA/CFDA guidelines)
  • Stability indicating method validation & transfer
  • Preparation & Approval of stability protocol
  • Sample management
  • Sample testing
  • Data & trend analysis & preparation
  • analytical training, documentation & internal audit
Stability Conditions include 
  • 20°C
  • 5°C
  • 25°C/60%RH
  • 30°C/65%RH
  • 30°C/60%RH
  • 40°C/75%RH
  • 50°C
  • Photostability
Drug Product
Method Evaluation Development & Optimization
Method Transfer & Validation

Drug Product specification & Support

Stability Studies
  • Siemens APOGEE Monitoring System
  • Full generator backup
  • Drug product, drug substance, placebo
  • Testing Capabilities: XRPD; Dissolution; Karl Fisher
Drug Product Testing & Release
  • Assay/impurities testing & method validation
  • Dissolution testing and method validation
  • Blend/content uniformity testing & method validation
  • Cleaning verification/validation
  • Protocol design
  • Long term stability testing
  • In-use stability testing
  • Accelerated stability testing
  • Forced degradation studiesTemperature cycling
  • Storage conditions: 25ºC/60% RH; 30ºC/65% RH; 40ºC/75% RH; 2-8ºC; -20ºC
  • Siemens APOGEE Monitoring System
  • Full generator backup
  • Drug product, drug substance, placebo
  • Testing Capabilities: XRPD; Dissolution; Karl Fisher

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BioDuro

  • US
  • 2018
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Contract Service
View company profile
Categories
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BioDuro

  • US
  • 2018
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Contract Service
View company profile

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