Analytical Chemistry and Method Development

The Role of Analytical Development in Pharma

Analytical chemistry plays a critical role in regulatory compliance, as regulatory agencies require that pharmaceutical companies provide evidence of the quality, safety, and efficacy of their products. Analytical methods must therefore be well developed and validated according to regulatory guidelines and standards, and the data generated by these methods must be robust, accurate, and reliable.

The main goal of pharmaceutical analytical development is to ensure that pharmaceutical products are of high quality, safe, and effective. This involves developing and validating analytical methods that can accurately and reliably measure the properties of the pharmaceutical compound or product. These methods are used throughout the drug development process, from early-stage development through commercialization and post-market surveillance.

CMC Pharma has a team of analytical chemists who are experts in method development, validation, and execution.

This includes the development of analytical methods by U/HPLC/ LC-MS and other techniques as well as the development and validation of potency and related substances with stability-indicating methods.

Equipment Includes:

UHPLC
ICH Stability Chambers
UV/Vis Spectrophotometer
Karl Fisher Titrator
Osmometer
Analytical Balances

Glove Boxes
Balance Enclosures
Tap Densitometer
Flowability Meter
Dissolution Apparatus
And More

Analytical Method Development

Our team develops and optimizes Analytical Methods to develop, evaluate and test drug products, API, and excipients. Robust analytical methods are critical to evaluate quality attributes such as potency, impurities, and stability. We utilize a wide variety of analytical techniques commonly found in pharmaceutical development labs, including U/HPLC, MS, UV, Dissolution, Osmolarity, Karl Fisher, and GC.

Method Validation Services

CMC Pharma Method Validation procedures follows ICH and GMP guidelines to ensure that analytical test methods produce repeatable, precise, and accurate results. Validated test methods may be used for cGMP studies, and the data generated may be used in filings with the U.S. FDA for product approval and other regulatory submissions.

Execution of Analytical Methods

Analytical methods are used for routine product release testing, stability studies, formulation development, and more. When a client-provided or compendial (USP) method is first established in our labs, method familiarity is performed on test samples to ensure accuracy, precision, specificity, and linearity, for example.

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With decades of experience testing pharmaceutical drug products, we provide clients with skillful analytical chemistry expertise.

Robust analytical methods are the cornerstone of drug product testing, ensuring the safety, efficacy, and quality of pharmaceutical products. These methods provide the precision and accuracy necessary to detect impurities, confirm ingredient identity, and quantify the active pharmaceutical ingredient (API) content. Reliable analytical testing is critical for demonstrating batch-to-batch consistency, which is essential for regulatory compliance and patient safety. Without validated, reproducible methods, pharmaceutical companies risk releasing substandard products, facing regulatory delays, or encountering costly recalls.

The experienced team at CMC Pharma regularly test APIs, drug products, excipients, and reference standards while executing a wide variety of analytical methods. These include Karl Fisher, osmolarity, dissolution, in vitro release testing, and others. Our scientist are also highly experienced with a large number of USP tests.

Commonly Performed Analytical Tests Include:

Purity & Potency

Purity and potency testing ensures pharmaceutical products contain the correct amount of active ingredients and are free from harmful impurities. It verifies dosage accuracy, detects contaminants, and confirms product efficacy, ensuring patient safety and regulatory compliance.

Release Testing

Pharmaceutical release testing ensures drug products meet regulatory standards for identity, potency, purity, and quality before reaching patients. Release testing should be performed on each batch, verifying consistency, detecting impurities, and confirming dosage accuracy.

Dissolution

Dissolution testing measures the rate and extent of drug that is released under standard conditions, simulating the drug product’s behavior in the body after administration. The drug release of the active ingredient in the solution is measured, ensuring consistent bioavailability, proper absorption, and therapeutic effectiveness.

Karl Fisher

Karl Fischer testing accurately measures water content in pharmaceutical products, ensuring stability and preventing degradation, which is essential for maintaining product quality and shelf life.

Osmolarity

Osmolarity testing ensures pharmaceutical products have the correct concentration of dissolved particles, preventing cell damage and ensuring compatibility with biological systems, which is vital for patient safety and product efficacy.

Viscosity

Viscosity testing verifies the thickness and flow properties of pharmaceutical formulations, ensuring consistency, proper dosing, and optimal performance in drug delivery systems.

Whether you need to develop robust analytical methods or require routine testing, Contact CMC Pharma to learn how we can help you advance your development program.

cGMP-Compliant Testing & Quality Assurance

At CMC Pharma, we prioritize quality and regulatory compliance by offering cGMP-compliant analytical testing and development services. Our laboratories are fully equipped to perform Good Manufacturing Practice (GMP) testing, ensuring that pharmaceutical products meet the stringent standards required by regulatory authorities, including the FDA and other global agencies.

Our cGMP testing capabilities support batch release and stability studies providing the robust data necessary for regulatory submissions. With validated methods and state-of-the-art instrumentation, we ensure the accuracy, reliability, and reproducibility of test results.

Explore Our Other Drug Development Lab Services: