Reverse Engineering of RLD

Reverse engineering is actually a process of drug preparation reproduction, that is, reverse analysis of the target Reference Listed Drugs (RLDs), so as to obtain key factors such as qualitative formulation, crystal form of APIs, content of excipients and preparation process. Reverse engineering projects can generate valuable data on active ingredients and excipient components that can be used for a wide range of applications. The type and dosage of excipients in generic drugs should be the same as that of the reference preparation. The purpose of reverse engineering research is to prepare a generic product with the same quality and efficacy as the RLDs. Alfa Chemistry is committed to providing reliable reverse engineering services for hundreds of the RLDs by delivering useful information to help generic drug companies accelerate their consistency evaluation.

Advantages of Reverse Engineering of the RLD

• Reduce the difficulty and workload of formulation development
• Shorten the time of development
• Increase the rate of BE adoption

Our Capabilities

Formulation Equivalence Studies

Qualitative and quantitative analysis of a variety of topical products

Equivalence studies for formulation of tablets, capsules as well as many types of controlled release products

Excipient Quantification Services

Quantitation of a range of commonly used excipients such as hydrocarbon-based ingredients, polymers, modified cellulose, and so on

Identification of the grade of material used as the excipient

Obtain the reference standards of this material to use for quantitation

Alfa Chemistry Reverse Engineering Workflow

Solid Dosage Formulations

1. Investigate the official websites of the drug regulatory authorities of the United States to determine the composition of excipients and the dosage of some excipients
2. Determine the dosage of excipients through a variety of detection methods
3. Determine the preparation process through electron microscope scanning
4. Determine whether the crystal form of the generic product is the same as the RLDs through X-ray diffraction and other methods

Injectables

1. Investigate the official websites of the drug regulatory authorities of the United States to determine the composition of excipients and the dosage of some excipients
2. Determine the amount of excipients used in the RLDs through a variety of testing tools

What We Offer?

RLD Prescription Analysis

Prescription analysis of the RLDs is an important component of preformulation studies that can provide critical information for formulation development of generic drugs. Alfa Chemistry provides routine basic analysis for our clients, including²UV-absorbing drugs, non-UV-absorbing detection solutions, and metal element detection solutions. Our experts offer high-quality reverse engineering services for the analysis of formulation composition of the RLDs.

RLD Principal Component Analysis

The analysis of the major composition of a prescription can provide useful information for the subsequent characterization of the RLDs. At Alfa Chemistry, a comprehensive analysis of the RLD prescription composition can be divided into three steps: 1. crystal forms analysis of APIs and excipients; 2. identification of main drug components (API, key excipients); and 3. quantitative testing of identified components.

Packaging Research of RLD

Drug packaging has a significant impact on the quality, safety and shelf life of drugs. We used diversified detection methods such as chromatography, mass spectrometry, and spectroscopy to detect and analyze the packaging of RLD in different dosage forms. The test results can be used as a reference for the quality and performance of generic drug packaging.

Our Advantages

• Complete data reports with supporting data and analytical details
• Each reverse engineering analysis project has a designated project manager who provides regular updates and meetings
• Alfa Chemistry supports multiple instruments such as gas chromatograph (GC), liquid chromatograph (HPLC), liquid chromatograph-tandem mass spectrometer (LC-MS/MS), gas chromatograph-tandem mass spectrometer (GC-MS), inductively coupled plasma mass spectrometer (ICP-MS), inductively coupled plasma emission spectrometer (ICP-OES), etc., which can provide comprehensive analytical services for reverse engineering of RLDs.