Generating generic drugs aims to achieve the same quality and efficacy as Reference Listed Drugs (RLDs). Using reverse engineering technology to study RLD in various aspects and angles can effectively reduce the difficulty of generic drug development, shorten the R&D time and improve the success rate of human bioequivalence tests.
Stability refers to the ability of an active drug substance or preparation to maintain its physical, chemical, biological, and microbiological properties. The purpose of drug stability tests is to investigate the law of drug change with time under the influence of set temperature, humidity and light, to provide a scientific basis for the production, packaging, storage and transportation conditions of drugs, and to establish the expiry date of drugs with reference to the test results.
Our Services
Our company has extensive experience in RLD reverse analysis and generic drug consistency evaluation. We are committed to helping generic drug manufacturers complete the full range of RLD analyses and accelerate the process of generic drug approval. We suggest that the stability of RLD should be investigated at the stage of reverse engineering research of RLD, especially the RLD that is sensitive to light, humidity and temperature and easy to oxidize according to literature reports or research data.
The specifications of the purchased RLD describe the storage conditions and expiry date of the drug, from which the expected stability of the RLD can be inferred. Refer to the RLD specification or data research to design the conditions and time points of the stability investigation. The results of RLD stability investigations can be used to guide the development of generic drugs, effectively avoid potential risks and reduce research workload.
Our Methods for Researching RLD Stability
- Stability of the RLD dissolution curve
NMPA suggests that for RLD with unstable physical and chemical properties, it is necessary to investigate the stability of the RLD dissolution curve to support the repeatability of laboratory review results.
The dissolution curve measures the pseudo-synthesis curve of multiple points, which is more intuitive, more sensitive and more real than the single dissolution degree in the expression of drug dissolution behavior trend, intrinsic quality, and changes in raw materials, prescription ratio and process parameters in the drug production process.
Our company will conduct an adequate risk assessment of RLD and your self-developed generic drug, and reasonably design a stability test strategy, such as specific test conditions and sampling time. We will save time and cost while ensuring an accurate assessment of RLD's dissolution curve stability.
The influence factor test, the accelerated test, and the long-term test can be conducted on RLD. Since the stability test of RLD has not been clearly required by national regulations, it is only necessary to carry out individual tests or individual factors. Our company can provide you with RLD stability test inspection indicators according to the dosage form. You can choose pH, solution color, character, content, related substances, water and so on. We will fully consider the amount of RLD, the degree of value and other factors, for targeted investigation and evaluation.
Our Capability
- Quantitative analysis of various RLD excipients (injection, oral solution, suspension, solid preparation, etc.), such as inorganic salts, sugar alcohols, organic acids, cellulose, etc
- Professional working background
- Declared multiple generic drug types for several generic drug manufacturers
- Standardized quality assurance system to ensure data accuracy, integrity, authenticity, and traceability
- Efficient workflow
