Formulation Quality Research

Formulation Quality Research

Alta Stomatology is a leading oral disease drug research and development company committed to advancing the field of stomatology through innovative formulations and rigorous quality research. At Alta Stomatology, we recognize the critical importance of formulation quality research in the development of effective oral disease drugs. Our team of experienced scientists and researchers is committed to conducting comprehensive formulation quality research. We provide a range of services including preparation analytical method development, analytical method validation, stability studies, and microbial detection to support the formulation quality research process and ensure the safety and efficacy of oral disease drugs. If you have any needs, please feel free to contact us.

Formulation Quality Research

Our Services

Formulation Analytical Method Development

At Alta Stomatology, our experienced team can develop and optimize analytical methods for analyzing the formulations of oral disease drugs based on the properties of the drugs, various pharmacopeias, literature, etc. We utilize state-of-the-art equipment and technology to develop robust and reliable methods to identify and quantify active ingredients, excipients, and impurities in pharmaceutical formulations, ensuring accurate and precise results.

Analytical Method Validation

The validation of analytical methods is crucial for determining the reliability and applicability of analytical methods commonly used in drug analysis. At Alta Stomatology, we offer comprehensive analytical method validation services for formulating drugs to treat oral diseases. Our validation includes specificity, linear range, accuracy, precision, detection limit, quantitation limit, ruggedness, and system suitability, among others, by pharmacopeial requirements to ensure the effectiveness, accuracy, precision, and robustness of the analytical methods. Through rigorous validation studies, we ensure the quality and integrity of the analytical data generated during the drug development and manufacturing process.

  • Enantiomeric Analysis Method Validation
  • Substance Analysis Method Validation
  • Uniformity of Content Analysis Method Validation
  • Content Determination Method Validation
  • Microbial Analysis Method Validation
  • Dissolution Rate Determination Method Validation
  • Bacterial Endotoxin Detection Method Validation
  • Impurity Content Determination Method Validation

Stability Studies

Stability studies play a critical role in determining the shelf life and storage conditions of oral disease drugs. Alta Stomatology offers comprehensive stability studies to evaluate the physical, chemical, and microbiological stability of oral disease drug formulations under various environmental conditions. Our state-of-the-art analytical instrumentation enable us to monitor and assess the stability of drug products over extended periods. By conducting systematic stability studies, we help our clients establish appropriate storage recommendations and shelf-life specifications to ensure the efficacy and safety of oral disease drugs throughout their lifecycle.

  • Design of stability study for different oral disease drug dosage forms
  • Study the physicochemical properties and stability of different oral disease drug dosage forms over time, and analyze the data trends
  • Evaluate the shelf life of oral disease drugs

Microbial Detection

Microbial contamination poses a significant risk to the safety and efficacy of the drugs, especially for oral disease drug formulations that come into direct contact with the oral cavity. At Alta Stomatology, we offer microbial detection services to identify and quantify microbial contaminants in drug formulations. We use validated methods and techniques for microbial testing, including bacterial and fungal identification, endotoxin testing, and preservative efficacy testing. Our microbial detection services help ensure the safety and quality of oral disease drugs by preventing microbial contamination.

  • Bacterial inhibition test of oral disease drugs
  • Sterility testing of sterilized preparations
  • Microbial limit testing of non-sterile preparations

Why Choose Alta Stomatology?

  • Expertise and Experience

At Alta Stomatology, we have a team of highly qualified scientists and researchers with extensive experience in formulation quality research. Our team has a deep understanding of the unique challenges and requirements of oral disease drug development and can provide expert guidance and support throughout the research process.

  • State-of-the-Art Facilities

We have state-of-the-art facilities equipped with the latest analytical equipment and technology to support our formulation quality research services. Our laboratories are designed to meet the highest standards of quality and compliance, allowing us to deliver accurate and reliable results for our clients.

  • Customized Solutions and Flexibility

Recognizing the diverse needs of our clients, we offer customized solutions tailored to specific project requirements. Whether it's method development, validation, stability testing, or microbial detection, we collaborate closely with clients to design personalized strategies that align with their objectives.

For research use only. Not intended for any clinical use.
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