Prescription analysis of the Reference Listed Drugs (RLDs) is an effective strategy to accelerate the process of consistency evaluation of generic drugs, as generic drugs are approved on the basis of therapeutic equivalence to the RLDs. he prescription analysis of RLD is an important part of pre-prescription research, which can provide key information for the formulation development of generic drugs. Generally speaking, the development of generic drug products starts with the prescription analysis of the RLDs, followed by the design of pharmaceutical equivalent drugs, so as to develop an effective production process.
The Role of RLD Prescription Analysis
- Accelerate the development of generic drug formulation
- Simplify the regulatory approval process
Our Capabilities
- Alfa Chemistry provides our users with routine basic analysis including UV-absorbing drugs, non-UV-absorbing detection solutions, and metal element detection solutions
- Our experts use the information of general literature resources, combined with reverse engineering research, to provide a comprehensive services for the analysis of formulation composition of the RLDs
Our Services
At Alfa Chemistry, our well-trained chemist can identify a wide range of elements, compounds and mixtures by using multiple wet chemical qualitative analytical techniques.
New drug candidates for the treatment of a variety of diseases are organic compounds, and many generic drugs on the market are also small-molecule organic molecules. Therefore, it is very important to fully study the organic components of the RLDs for the consistency evaluation of generic drugs. Alfa Chemistry provides liquid chromatography-mass spectrometry (LC/MS) and high-performance liquid chromatography (HPLC)-ultraviolet absorption analysis methods to identify organic compounds in RLDs. In addition to the above routine services, for the identification of volatile and semi-volatile organic compounds in the RLD, we offer GC/MS analysis services to analyze leachable organics in formulations.
Most generic drugs on the market are designed and manufactured in specific salt forms to improve the solubility, stability and bioavailability of the product. However, these ionic components lack the chromophores that are necessary to be able to be analyzed by absorption measurements, making their detection and quantification a challenge. As an important part of drug equivalence evaluation, Alfa Chemistry provides identification and quantitative analysis services of ionic components in the RLD preparations. Our experts provide Ion Chromatography (IC) and High Performance Liquid Chromatography to identify ionic compounds in the RLD prescription, enabling excellent detection from high to low concentrations to ensure the pharmaceutical equivalence between your manufactured generic and the RLDs.
The presence of metal elements in generic drug formulations has always been the focus of drug design and manufacturing, and the control of metal components provides maximum safety for patients. According to the recommendation of USP, Alfa Chemistry offers a complete elemental analysis solution for the RLDs including plasma spectrochemistry (Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES) and Inductively Coupled Plasma-Mass Spectrometry (ICP-MS)) and Atomic Absorption Spectroscopy(AAS). Our experts strictly follow the USP-NF process to help you quickly detect and analyze metal elements in the RLD preparations to meet FDA's requirements for the consistency evaluation of generic drugs.
Drug stability is the ability to maintain its physical, chemical, and microbiological properties. Generic drugs need to be comparable in stability to RLD to ensure efficacy and quality. We assessed the RLD's stability by measuring the stability of the dissolution curve or by examining the stability under influence, accelerated, and long-term tests.
The preparation process is a key step affecting drug quality, and drug quality comes from design rather than inspection. We investigated the preparation process of RLD by Raman imaging and SEM-EDS techniques. We help pharmaceutical companies fully understand the preparation process of RLD to accelerate their generic drug development process.
In the pre-prescription research phase, RLD properties need to be fully studied. We provide comprehensive measurements of RLD physical and chemical parameters, including appearance, clarity, pH, relative density, osmotic pressure, viscosity, visible foreign bodies, insoluble particles, Zeta potential and rotational luminosity. Our physical and chemical testing platform has a variety of advanced instruments and testing methods, and is committed to providing quality goals for generic drug research and development.
