Pharmaceuticals & Medical Devices Deformulation Analysis

Reverse engineering plays a vital role in design and manufacturing based industry. This technique has been widely recognized in the product development cycle. Of course, the pharmaceutical and medical device industries are no exception. Our company has extensive experience in reverse engineering analysis of drugs and medical devices. We can perform geometric characterization, identification of ingredients, concentrations analysis for various drugs (including tablets, capsules, lotions, and creams) and medical devices (for example, the pre fill syringe). Then we will help you understand the properties of each aspect in depth to optimize product quality and develop new products.

There are diversified levels of deformulation analysis that may be performed on any given drug and medical device.

The contents we can analyze include:

• Major component identification: we will identify the main components and quantify them, clarify its main role in the drugs, and provide theoretical basis for the formulation engineers.

• Formula identification: we will identify and quantify all components of the system, including supplemental saline, colorants and taste masks, time release technology, and tablet coating systems.

• Medical devices shape and geometry, and also its content concentration, composition and properties.

• The determination of processing conditions, using 3D printers, computer-aided design and building digital models.

• Identification and quantitation of all impurities and process markers in the system. All of this information is needed to meet ANDA-approved standards.

Our Facilities:

• Gas Chromatography-Mass Spectrometry (GC-MS)

• Thermogravimetric Analysis (TGA)/Differential Scanning Calorimetry (DSC)

• Fourier Transform Infrared Spectrometry (TGA-FTIR)

• Liquid Chromatography-Mass Spectroscopy (LC-MS)

• Scanning Electron Microscopy-Energy Dispersive Spectrometry (SEM-EDS)

• Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES)

• Nuclear Magnetic Resonance (NMR)

• Gel Permeation Chromatography (GPC)

• Dynamic Light Scattering (DLS)

• 3D Laser Scanning

• CAI (Computer-aided Inspection) and CAV (Computer-aided Verification)

• CGI Scanning

• Computer-aided Design (CAD)

Advantages:

• Rich experience and advanced analytical and testing technology.

• The professional and detailed analysis results and reliable data.

• The shortest time and the least cost.

We have experienced and skilled scientists to provide customers a satisfactory report on the deformulation of pharmaceuticals and medical devices. We offer the latest technologies to ensure fast, cost-effective and accurate reverse engineering services. Please do not hesitate to contact us for your reverse engineering projects.