Laboratory Testing Services

Pharmaceutical Analysis
of raw materials and/or finished products

Pharmaceutical analysis is an integral partner to the drug development process. Medipharm Laboratories can perform a vast array of analyses on pharmaceutical products from a variety of compendiums to ensure that products are safe and effective.

Our comprehensive suite of tests help manufacturers and suppliers to determine the identity, purity, content, and stability of starting materials, inactive substances, and active pharmaceutical ingredients, including data regarding their stability, shelf life and related manufacturing processes.

Our technical capabilities include the following instrumentation, equipment, and analytical methodologies:

• High performance liquid chromatography (HPLC)
• Gas chromatography (GC)
• Infrared (IR)
• Ultraviolet/visible (UV/VIs)
• Identification of raw materials by IR, HPLC, TLC, UV, GC or wet chemistry (color or precipitate formation)
• Chromatography purity by TLC, HPLC or GC
• Microbiological analysis <61>, <2021>, <2022> and <2023>
• Stability studies ( accelerated or at room temperature)
• Verification of the whole monograph from the United States Pharmacopeia (USP)
• Dissolution and Disintegration tests
• Content uniformity <905>
• Determination of some chemical or physical properties such as:
  • acid value
  • acidity/alkalinity
  • appearance
  • boiling point
  • heavy metals
  • Iodine value
  • loss on drying
  • loss on ignition
  • melting range
  • optical rotation
  • pH
  • refractive index (RI)
  • residue on ignition
  • saponification value
  • specific gravity (SG)
  • sulfate limit
  • viscosity

Pharmaceutical assays