Analytical Chemistry and Physical Testing

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Analytical Chemistry and Physical Testing services play an important role in the drug development process and during the manufacturing of pharmaceutical products. Analytical testing is used to identify the chemical composition and molecular structure of each individual substance contained in a drug product. This knowledge provides insight into a drug’s performance and safety. Testing may even reveal contamination in the manufacturing production process or highlight other, previously unknown risks with the formulation. Concerns about drug safety, costly development programs, complex manufacturing, and increased regulatory requirements are all issues that can be addressed through a better understanding of your product or manufacturing process, which, can be achieved through performing the correct analytical studies and generating robust data.

Infinity Laboratories provides high quality analytical data delivered on time. Our experienced chemists along with state-of-the art instrumentation will satisfy all your analytical needs. Our internal QA group routinely audits each of our areas for strict compliance with cGMP requirements. We have the size and capacity to meet the most demanding turnaround time requirements. We are experienced in testing all types of raw materials, utilities, solid dosage forms and immediate release products, to controlled release products, liquids, suspensions, and niche formulations such as aerosol and transdermal products.

Test

Method

  • Antimicrobial AgentsUSP 341
  • Appearance EvaluationVisual
  • Chemical Potency/Purity/IDUSP 621
  • Container Closure Integrity TestingUSP 1207
  • Dosage UniformityUSP 905
  • Material Identification (FTIR)USP 197
  • Melting RangeUSP 741
  • Method DevelopmentUSP 1225
  • Particulate Matter in InjectablesUSP 788
  • pHUSP 791
  • Specific & Optical RotationUSP 781
  • Water Content (Karl Fisher)USP 921
  • Elemental ImpuritiesUSP 232/233
  • Residual SolventsUSP 467

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