Request A FREE 30 Minute Consultation With A PhD Scientist

REQUEST CONSULTATION

CMC Laboratory

Learn More About Our CMC Lab Services for Drug Development and Manufacturing

Our broad base of drug product development experience and wide range of formulation equipment and analytical instrumentation allows us to customize projects to meet our customer’s needs in a timely and cost efficient manner. We have experience in a wide range of small molecule and macromolecular drugs and are committed to providing our clients with only top tier technical information and results. We have a wide array of equipment and capabilities and are constantly adding more. We can determine how to best execute nearly any study that our clients require to measure the identity, strength, quality, purity, and potency of a drug product.

THE TESTS AND SERVICES THAT OUR LAB HAS CAPABILITIES FOR INCLUDE

CMC Laboratory for drug product development

Density Measurement
We quantify tapped and bulk densities of substances utilizing standard industry instrumentation.

Dissolution Testing
USP dissolution apparatus provides us the capabilities to execute the dissolution of a wide variety of dosage forms by the USP and other compendial requirements.

Formulation Preparation
We can prepare a number of formulations including oral solids (capsules, tablets), liquids (solutions, suspensions, and sterile and non-sterile forms), in addition to a variety of novel dosage forms.

HPLC/UPLC
Liquid chromatography instrumentation provides capabilities to precisely test a large range of substances to determine potency, purity, degradation, and composition.

Karl Fisher (KF) Titration
KF is a classic titration method that we use to efficiently and accurately measure the moisture content of many substances from powders to solutions.

LC-Mass Spectrometry (MS)
Our LC mass spectrometry detector provides a valuable tool for method development, impurity & degradant identification, and a variety of trouble shooting applications.

pH and Buffering
We can perform accurate pH measurement of solutions and samples over a wide range and recommend appropriate buffering systems for your drug product development and test methods.

Powder Flow Testing
This process allows us to quantify powder flow by the angle of repose, flow through and orifice, or mass flow rates.

Reference Standard Qualification
We use qualified and certified working reference standards by ID, assay (by LC or LC-MS), and moisture (Karl Fisher) testing. Aliquots are prepared, placed on stability, and re-certified as required.

Solubility Screening
This is a series of procedures that allow us to evaluate the solubility of active pharmaceutical ingredients in a number of pharmaceutically relevant solvents.

Stability Chambers
Our stability chambers are temperature and humidity controlled. They are frequently used in a variety of long-term, accelerated stability, and forced degradation studies.

V-Shell Blender
We are able to efficiently blend a variety of powders and granulations to meet our customer’s specification.

Let us help you meet the FDA’s CMC requirements for your drug development program. We can use all of the methods above (and are constantly adding more) to help you meet requirements of the U.S. FDA and other world-wide regulatory bodies. Request a meeting today to learn more about our laboratory and the services we provide.