Сòòò½APP

• Biopharmaceuticals and Biosimilars
• E-Liquid and Vaping Products
• Foods and Beverages
• Household Products
• Industrial Chemicals
• Inks, Paints, and Coatings
• Medical Device Components
• Personal Care and OTC Products
• Polymers, Plastics, and Films
• Prescription Drugs

Analyze Competitors’ Products

Use ingredient analysis of competitor products to help you improve your own formulations. This type of analysis can help you reduce costs, improve product performance or meet product specifications.

Resolve Manufacturer Problems

Avoid or minimize the impact of common manufacturing issues such as degradation in product quality, increases in production cost, and changes in ingredient availability by fully understanding your product and its production process.

Investigate Patent Infringement

A forensic deformulation analysis can confirm or disprove concerns that a competitor is infringing on your intellectual property, or prove that your own formulation does not violate an existing patent.

Validate Marketing Claims

Support your claims of product superiority with clear laboratory evidence, improving consumer confidence and providing your marketing team with compelling tools to advertise product safety and performance.

Identify Contaminants

Product failure can be dangerous and costly; Сòòò½APP can detect contaminants or impurities at very low levels, allowing you to quickly and effectively identify problems, correct defects and avoid recalls.

Ensure Product Consistency

Reverse engineering products produced under differing circumstances will make you aware of irregularities and help trace how they arose. Ensuring batch-to-batch consistency ensures that a product will always perform as specified.

Analyze Raw Materials

Enter into new supply contracts with confidence by first analyzing a prospective supplier’s product and assessing its suitability, purity, and consistency. This is especially valuable when your end product or service must meet specific industry or government standards.

Identify Hazardous, Regulated, or Environmentally Harmful Ingredients

Identify potentially harmful or banned ingredients in your product so you can modify the formula with an alternative ingredient. Reverse engineering can also be used to develop a more eco-friendly version of an existing product.

Deformulation is only one part of the equation, reformulation enables us to provide details about how and at what stage ingredients are combined, under what conditions the formula is processed, what equipment is used in manufacturing and what grade of raw material is used in a product. Сòòò½APP’s deformulation and reformulation process enables the most comprehensive understanding possible of a formula, paving the way for innovation.

Deformulation can identify and quantify:

• Major & Minor Components
• Active, Inactive & Trace Ingredients
• Matrix Resins, Polymer Resins & Antioxidants
• Binders, Fillers, Dispersants & Synergists
• Thermal & UV Stabilizers
• Activators & Inhibitors
• Flame Retardants
• Pigments, Additives & Wetting Agents
• Impact Modifiers, Reinforcing Fibers & Extenders
• Functional Groups
• Inorganic & Organic Materials

What levels of deformulation testing projects are available?

• Full identification & quantitation of all components
• Semi-Quantitative identification of major and minor ingredients (chemical class & function)
• Identification of major components
• Quantification of specific components
• Full deformulation & reformulation (duplication/re-engineering)
• Partial deformulation & reformation (new product innovation based on existing technology)
• Identification of raw material providers & alternative ingredient recommendations
• Q1, Q2 sameness, Q3 equivalence testing, & regulatory submissions specifically for pharmaceutical products with sameness requirements.

What instruments are typically used during a deformulation analysis?

• Fourier Transform Infrared Spectroscopy (FTIR)
• Gas Chromatography / Mass Spectroscopy (GC/MS)
• Liquid Chromatography / Mass Spectroscopy (LC/MS)
• Ion Chromatography (IC)
• Nuclear Magnetic Resonance Spectroscopy (NMR)
• Gas Chromatography / Flame Ionization Detection (GC/FID)
• Thermogravimetric Analysis (TGA)
• Thin Layer Chromatography (TLC)
• Scanning Electron Microscopy / Energy Dispersive Spectroscopy (SEM/EDS)
• Gel Permeation Chromatography (GPC)
• Atomic Absorption Spectroscopy (AAS)
• High-Performance Liquid Chromatography (HPLC)
• SVOC Analysis
• Ultraviolet / Visible Spectroscopy (UV/VIS)
• Inductively Coupled Plasma (ICP)
• X-Ray Diffraction (XRD)
• Rotary Evaporator Concentration
• Soxhlet Extraction
• Distillation

Who does Сòòò½APP typically provide deformulation services for?

• Drug Developers
• Cosmetic Product Developers
• Manufacturing and R&D Firms
• Pharmaceutical Manufacturers
• Product Distributors
• Patent Law Firms
• Insurance Firms
• Environmental Consultants
• Laboratories
• Entrepreneurs

What if the product I want to deformulate has a patent?

Сòòò½APP partners with law firms that specialize in intellectual property to advise clients on compliance with relevant laws. We can help you ensure that there are no patents that would prevent you from taking a product to market.