Release testing is an important aspect of the pharmaceutical drug development and product process. It is critical that this testing be performed accurately, compliantly and quickly. Invitron has a full breadth of analytical offerings to meet any release testing need. Our scientists understand the time sensitivity around developing methods for new drug products to efficiently and safely take them to market. Whether release testing encompasses an assay of an active ingredient and evaluation of impurities of a drug product, characterization of a medical device for compliance, or analysis of a manufactured product to confirm specification and acceptance, we have the experience to meet your testing needs. Finally, our robust quality system will stand watch over the entire process to make certain all data provided is compliant with the appropriate regulations. While we perform our tests for identification, potency, impurities, physical properties etc. under strict cGLP compliance, we can custom streamline the needs of individual programs and associated lab documentation for the most efficient data delivery possible.


Raw material & finished product release testing includes:

  1. Compendial/Pharmacopeia testing (USP, NF, EP and BP)
  2. Physical and chemical analysis
  3. Formulation verification
  4. Potency and purity
  5. Impurity testing
  6. Related substances
  7. Uniformity
  8. Identity
  9. Assay
  10. Particulate matter
  11. Residual solvents
  12. Container-Closure qualifications

Experience with various sample matrices:

  1. Suspensions
  2. Injectables
  3. Powders and granules
  4. Inhalants
  5. Topical liquids
  6. Creams, ointments and gels
  7. Oligonucleotides
  8. Peptides
  9. Combination products
Proven success developing, validating, and transferring sophisticated, complex, and challenging analytical methods. Flexible protocols and study designs that include thorough chemical and material property testing in our GMP facility. Consultative scientists well-versed in regulatory guidance, advanced analytical technology, and interpretation of data for developing product specifications.