Our company provides professional formulation quality research services to our customers. Our experts have decades of experience working with a wide range of ICH and CFDA regulations and guidelines. We have helped many customers successfully complete pre-drug preparation and drug formulation studies. We can provide reliable data for filings.
Service Overview
Below are the key elements of Our company's preparation quality research service.
Method Development and Validation
- In the process of drug synthesis and storage, we choose assays with high specificity, sensitivity, and reproducibility because of the small amount of the substance in question.
- For drugs without standards, we perform analytical methods and optimize them according to drug properties, product characteristics, FDA, national pharmacopeias, literature, etc.
- For the research in the existing national standard drugs, we can not mechanically apply the existing national standards, we need to develop products with the goal of consistent safety and efficacy with the marketed products, and develop individual standards for specific varieties.
- According to the drug characteristics, ICH and national pharmacopeia requirements, we complete the required analytical method validation, including enantiomeric method validation, relevant substance analysis method validation, content uniformity method validation, content determination method validation, microbial method validation, dissolution determination method research, drug bacterial endotoxin detection, and impurity content determination.
Stability Studies
Stability studies are one of the main elements of drug quality control research and are closely related to drug quality research and the establishment of quality standards. It is stage-specific and runs through the whole process of drug research and development.
- We design stability studies according to different placement conditions for different dosage forms of products.
- We cover different study items according to different dosage forms of products.
- We select different packaging materials according to different dosage forms.
- We examine the time points based on the physicochemical properties and stability trends of the drug.
We provide stability study protocol design, project management, stability sample storage and testing, data trend analysis, and drug shelf life assessment.
Microbiological Testing
- Bacteria inhibition test of drugs.
- Sterility check method for sterile preparations.
- Microbial limit inspection of non-sterile preparations.
Research Capabilities
Our company is experienced in quality studies of inhalation formulations, topical dermal formulations, and ophthalmic drugs.
| Inhalation Preparations | In addition to conventional physicochemical indicators, special tests are included, such as aerodynamic particle size distribution, microparticle dose, delivery agent homogeneity, as well as delivery rate and total delivery volume. |
| Topical Skin Preparations | - Formulation pH.
- Water activity.
- Undissolved drug/dissolved drug ratio.
- Rheological properties.
- Yield stress values.
- Linear viscoelastic response.
- Viscosity curves.
- Linear viscoelastic range.
- In vitro release behavior and in vitro permeation behavior (IVPT/IVRT).
- Particle size and droplet size distribution determination.
- Microbiological examination method establishment.
- Bacteriostatic potency method establishment.
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| Ophthalmic Drugs | Our company has many years of practical experience and a well-instrumented testing system to fine tune the operation and testing of the eyes of experimental animals. |
If you want to know more about service details, please feel free to contact us.
It should be noted that our service is only used for research, not for clinical use.
