Protheragen-ING Lab provides precise and reliable pH testing services as part of our comprehensive drug physical and chemical analysis offerings. Our state-of-the-art laboratories and experienced chemists ensure that your products meet the necessary regulatory standards and maintain their intended performance.
Importance of pH testing
- Stability: The pH of a drug can affect its chemical stability, with certain compounds being more stable at specific pH ranges. Ensuring the optimal pH can prevent degradation and prolong the shelf life of the product.
- Solubility: The solubility of many drugs is pH-dependent. Accurate pH testing helps in determining the appropriate formulation to enhance solubility and bioavailability.
- Efficacy: The therapeutic efficacy of some drugs can be influenced by pH. Proper pH testing ensures that the drug maintains its intended pharmacological activity.
- Safety: Incorrect pH levels can lead to adverse reactions or reduced efficacy, impacting patient safety. Regular pH monitoring is crucial for maintaining the safety profile of the drug.
Our pH testing services
At our state-of-the-art analytical laboratory, we offer comprehensive pH testing services to meet the diverse needs of our clients.
Comprehensive Analysis
a. Raw Materials: pH testing of active pharmaceutical ingredients (APIs) and excipients to ensure quality and consistency from the start.
b. In-Process Samples: Monitoring pH during various stages of the manufacturing process to ensure optimal conditions and prevent deviations.
c. Finished Products: Final pH testing of the drug product to confirm it meets specifications before release.
Advanced Equipment
We employ a range of pH measurement techniques, including:
- Benchtop pH meters
- Portable pH probes
- Automated pH titration systems
- Ion-selective electrodes
The choice of method depends on the specific requirements of the sample, such as volume, viscosity, and chemical composition. Our equipment is regularly calibrated and maintained to adhere to stringent quality standards.
Regulatory Compliance
Our pH testing methods comply with international guidelines, including those set by the FDA, EMA, and ICH. We provide detailed reports that support your regulatory submissions and quality assurance processes.
Customized Solutions
Recognizing that different drugs may require specific testing conditions, we offer tailored pH testing protocols to meet your unique needs. Our experts work closely with you to develop and implement customized testing strategies.
Sample preparation and analysis
Our pH testing process involves the following steps:
A. Sample collection and preparation: We work closely with clients to ensure proper sampling techniques and handling procedures are followed to maintain sample integrity.
B. Calibration and method validation: Before analysis, our instruments are calibrated using certified pH standard solutions, and the testing methods are validated to meet industry standards.
C. pH measurement and reporting: The pH of the sample is measured, and the results are reported with the appropriate units, temperature, and other relevant information.
For more information about our pH testing services or to discuss your specific requirements, please contact us.