Analytical Services

 

ANALYTICAL CHEMISTRY CAPABILITIES


Raw Materials Testing

Bionex offers comprehensive raw materials testing services to the pharmaceutical industry including qualification of compendial methods, as well as development, qualification and validation of new methods. Bionex performs testing for the release of the raw materials for production or vendors’ qualification purpose. All tests are performed in accordance with USP/NF, BP, EP, JP, ACS and FCC methodologies/monographs, as well as any client-supplied or vendor-defined methods.


Finished Products Testing

Bionex offers full release or client selected testing for any type of formulation/dosage form. Bionex Analytical Chemistry Group has a broad range of experience in performing tests for in-process materials as well as finished products using either compendial methods or client supplied in-house methods. If necessary, Bionex will also offer method validation, verification, and transfer of the test methods in compliance with ICH and FDA regulatory requirements.

The tests for finished products include, but are not limited to:

  • Physical Testing
  • Dissolution Testing
  • Content/Blend Uniformity
  • Assay
  • Related Substances
  • Preservatives (for liquid dosage form)

Stability Testing and Storage

Bionex provides secure storage and stability testing of bio/pharmaceutical samples according to client specified procedures and stability protocols. Our stability chambers are setup per ICH guidelines at the storage conditions of 25°C/60%RH, 30°C/65%RH, and 40°C/75%RH. We . We can also set up stability conditions other than those specified by ICH. Bionex also offers consulting services for preparation of stability protocols, and to develop, validate, or transfer test methods for stability testing.


Impurities Testing

Impurities or related substances are usually required in testing for API release, finished product release and stability testing of degradation products. In many circumstances, special efforts are to be taken to separate, identify and quantify the impurities and related substances at certain levels satisfying the regulatory requirements. Bionex staff has extensive experience in developing and validation the analytical methods to meet your impurity testing needs.

The impurity testing includes, but is not limited to:

  • Residual Solvents/Impurities by USP <467> or customized method
  • Process Impurities/Related Compounds by compendial or customized method
  • Degradation products by compendial or customized method
  • Forced degradation study, identification and characterization of above limit degradation products
  • Tracking and trending analysis of related substances in stability studies

 

 

 

METHOD DEVELOPMENT AND VALIDATION


Method Development

Bionex staffed analytical experts with extensive experience in analytical method development, troubleshooting and validation. Our scientists have strong chemistry knowledge in combination of all chemical fields. When developing or troubleshooting analytical methods, we will consider all effects in the method such as the optimized separation conditions, selection of solvents to avoid any analyte-solvent interactions, solution stability for both assay and related substances, filter study, specificity, and sensitivity.


Method Validation

Bionex performs method validation with either full cGMP compliance per ICH guidelines Q2(R1) and USP <1225> or client directed partial validation, verification or transfer. Depending on the testing purpose of the methods, the characteristics of the method to be validated include, but some are not necessarily required, system suitability (an integral part of the method), accuracy, precision (repeatability and reproducibility), specificity, linearity, detection and quantitation limits, and robustness (deliberate variation in method conditions and solution stability). Bionex also performs method verification or transfer from or to client’s laboratories.


 

 

 
 
For more information, please call or email us at info@bionexpharma.com
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