上海葆隆生物科技有限公司
Shanghai Baolong Biotech Co.,ltd

We provide below pharmaceutical quality study services in house and for our clients : ( including not limited to )

API and formulation development support

  • Analysis method development and pre-validation ofHPLC,GC,isomer

  • Impurity profile confirmation,process impurity include key intermediate and specific impurity

  • Impurity and intermediates identification and partly structure characterization

  • Influence factor and impurity study of forced decomposition and aid decomposition

  • Purity, related substances and dissolution test

  • Preliminary stability test

  • Raw material, excipients testing

API and formulationrelease test

  • Analysis method confirmation of related substanceand purity

  • Testing based on quality specification ,include dissolution , identification , content, related substances ,solvent residue,rotation acidity solution clarity and color,chloride and phosphate and otherinorganic impurity ,water content , heavymetal ,ignition residue ,loss ondrying

  • Issue COA and release

Standard sample preparation

(Include impurity reference sample calibration, and first ,secondary standard sample calibration)

  • Analysis method confirmation of related substanceand purity

  • Calibration according to quality standard , andadditional test that influence on calibration results

  • Structure confirmation test ,NMQ (QNNR if necessary), UV,IR,MS

  • Writing experiment report and issue COA

  • Standard sample repack and release

Analysis method validation

include purity,related substance ,dissolution ,residue solvents ,isomers

  • Confirmationof Pre-validated method

  • Preparevalidation protocol and approval

  • Validationexperiment of analysis method

  • Write validation report and approval

Stability study

  • Confirmation of the validated analysis method

  • Prepare stability protocol and approval

  • Prepare stability test material and retained sample

  • Management of process stability experiment

  • Stability study process management

  • Stability report

Pharmaceutical quality study

(include pharmaceutical quality study part of API and formulation, provide CTD document )

  • Analysis support for API and formulationdevelopment

  • Impurity profile confirmation

  • API impurity characterization and final productcharacterization

  • Confirmation analysis method , in-process controlstandard ,make the specification draft of final product

  • Reference sample preparation

  • In process control and final product test duringpilot production for API and formulation

  • Analysis method validation

  • API and formulation release

  • Analysis method transfer

  • Stability study

  • Prepare the whole set documents of pharmaceutical quality studyand revise