The selection of reference preparations is the first phase in the consistency evaluation of generic drugs, which is of great significance to the quality evaluation of generic drugs. For generic drug manufacturers, the determination of reference preparations has become an important task in the consistency evaluation, whether it is for the development of generic drugs or quality evaluation of generic drugs. Generic drug manufacturers need to clarify the information of reference preparations and select appropriate reference preparations. By studying the characteristics of the reference preparations, we help you investigate the basic performance that the formulation should achieve. In addition to selecting and evaluating the reference preparations, Alfa Chemistry also provides quality control services for raw materials to ensure that your APIs and excipients can meet the demands of generic drug development.
What is Reference Preparation?
Reference preparation refers to a control drug used for the evaluation of the quality and efficacy consistency of the generic drug. In general, reference preparations are reference listed drug or the internationally recognized drug of the same kind.
Our Services
Determination of Reference Preparations
Domestic marketed reference listed drugs are preferred, which refer to the first domestic and foreign drugs approved for marketing, and have complete and sufficient safety and effectiveness data as the basis for marketing. If the reference listed drug is not marketed in the United States or there is evidence that the reference listed drug does not meet the conditions of the reference preparation, we choose a generic drug that has been approved for marketing in the United States and has obtained the status of the reference preparation.
Inspection of Raw Materials
- Determination of the legal origin of raw materials
- Inspection of raw materials and excipients with reference to Pharmacopoeia standards or other relevant standards
Inspection of Reference Preparations
In the consistency evaluation, the quality of the reference preparation should be guaranteed. At Alfa Chemistry, our experts carry out a comprehensive testing of the reference preparation, and the test items are not limited to the proposed formulation quality standards:
- A range of quality attributes such as shape, crystal form (raw material), moisture, dissolution or release, content, related substances
- Intra-batch and batch-to-batch uniformity of the reference preparation, and related statistical analysis of the average value and standard deviation
- Solid oral preparation: Determination of dissolution curve of the reference preparation
- Pharmaceutical preparations sensitive to the pH value: Determination of the pH value of the 5% suspension
- Liquid preparations: Detection of viscosity, osmotic pressure and pH value
Alfa Chemistry's Advantages
- We have accumulated rich experience in successfully selecting a variety of reference preparations for cooperative pharmaceutical companies.
- Additional consulting services: consistency evaluation policy, reference preparation selection, technical consultation.
- Alfa Chemistry performs project design and research in accordance with the relevant regulations and guidelines of the FDA and its subordinate departments.
