Ensuring the safety, efficacy, and consistency of drug products is paramount, and robust quality control (QC) methods are the foundation of a reliable quality assurance program. Protheragen-ING Lab specializes in comprehensive pharmaceutical QC Testing, focusing on the development and validation of QC methods that meet the stringent requirements of regulatory authorities such as the FDA, EMA, and ICH.
Developing effective QC methods
Our QC method development services are designed to provide robust, accurate, and reproducible analytical methods for drug product evaluation. These services cover a wide range of techniques and methods to meet the specific needs of each client and product.
Analytical Technique Selection
We develop custom analytical methods to identify, quantify, and characterize active pharmaceutical ingredients (APIs) and excipients in pharmaceutical products. Our methods cover a wide range of analytical techniques, including chromatography (HPLC, GC), spectroscopy (UV, IR, MS), and a variety of other instrumental analyses. Our team evaluates the available options to determine the most appropriate technique based on product attributes, desired sensitivity, and regulatory requirements.
Method Optimization
Once an analytical technique has been selected, our team focuses on optimizing the method parameters to achieve the desired performance characteristics. This may include adjusting mobile phase composition, column selection, sample preparation procedures, and detection conditions to ensure accurate, precise, and reproducible results.
Method Validation
Our validation process ensures that the methods developed are reliable, reproducible, and meet regulatory guidelines. We conduct comprehensive validation studies including specificity, linearity, accuracy, precision, range, detection limit, quantification limit, robustness, and stability.
Our expertise and capabilities
Pharmaceutical QC testing encompasses a wide range of analytical techniques and procedures designed to evaluate the quality attributes of drug substances, drug products, and related materials. These tests may include:
| Stability Testing | Our stability testing services include method development for stability-indicating assays, accelerated and long-term stability studies, and photostability testing in compliance with ICH guidelines. |
| Dissolution Testing | We develop and validate dissolution testing methods to assess the release profile of solid oral dosage forms. Our dissolution testing services ensure that products meet regulatory specifications and perform consistently. |
| Impurity Profiling | We develop methods for the detection and quantification of impurities, including degradation products, residual solvents, and elemental impurities, following ICH Q3A/B/C guidelines. |
| Microbiological Testing | Our microbiological testing services include method development for sterility testing, microbial limits testing, endotoxin testing, and bioassays to ensure the microbiological quality of pharmaceutical products. |
| Strength/Potency Testing | We develop analytical methods to evaluate API concentrations and ensure that they meet regulatory requirements. |
Contact us today to learn more about our services and how we can support your product development and regulatory compliance efforts.