TOC testing is used to detect and quantify organic contaminants that may be present in pharmaceutical-grade water systems. It serves as a sensitive indicator of overall organic cleanliness and water system performance. TOC confirms water meets USP and cGMP quality requirements, supports clean-in-place (CIP) validation and equipment rinsing procedure, detects organic residues from raw materials, microbes, and cleaning agents, and is essential for water system qualification, routine monitoring, and OOS investigations

Measures the electrical conductivity of pharmaceutical-grade water, including Purified Water and Water for Injection (WFI). Conductivity is used to assess the ionic purity of water and detect the presence of inorganic contaminants such as salts, acids, or bases. This test is required for water system validation, routine monitoring, and regulatory compliance with USP and cGMP standards.

Measure the pH of pharmaceutical products using calibrated pH meters. pH testing is critical for verifying product stability, solubility, safety, and compliance with monograph specifications during development, manufacturing, and release.

Determine the refractive index of a liquid substance using a refractometer. This test is used to identify compounds, assess purity, and confirm concentration of solutions in compliance with USP specifications. It is commonly applied to raw materials, excipients, and finished products.

Determine the specific gravity or relative density of a liquid substance. This measurement compares the density of a sample to that of water and is used for identification, quality control, and concentration verification of raw materials and finished products in accordance with USP standards.

Validated methods for determining the water content in pharmaceutical substances and products, most commonly using Karl Fischer titration. Accurate water content measurement is essential for ensuring product stability, potency, and compliance with USP monographs.

The general requirements and system suitability guidelines for liquid chromatography (HPLC) and gas chromatography (GC). It ensures that chromatographic methods used for drug substance and product testing are accurate, reproducible, and pharmacopeially compliant. This chapter governs key parameters such as column type, flow rate, injection volume, and resolution criteria.

Identify substances using UV-Visible and Infrared (IR) spectrophotometry. These techniques are used to confirm the identity of raw materials and finished products by comparing spectral data to reference standards, ensuring they meet USP requirements. This is often performed as part of raw material qualification, identity testing, or method verification.

Conducted to determine how the quality of a drug substance or product changes over time under the influence of environmental factors such as temperature, humidity, and light. Stability programs are designed in compliance with ICH guidelines to support product development, shelf-life determination, regulatory submissions, and ongoing quality assurance. Stability studies are essential for establishing product expiration dates, determining storage conditions, and ensuring regulatory compliance in global markets.

Design and optimize robust analytical methods for accurate measurement of critical quality attributes such as potency, impurities, degradation products, excipients, and preservatives. Each method is tailored to the specific formulation and regulatory requirements. Manage the seamless transfer of validated methods from one site or organization to another through structured Method Transfer Protocols (MTPs). Our process ensures consistent performance and compliance across locations. Perform method verification to confirm suitability in your product matrix and laboratory system, in accordance with USP <1226> and regulatory guidelines. Accurate and validated methods are the foundation of pharmaceutical quality control.

Compendial testing involves analytical procedures defined in official pharmacopeias- USP/NF, EP, and JP. These standardized methods are used to assess the identity, strength, quality, purity, and performance of pharmaceutical substances, excipients, and finished products. Using pharmacopeial methods reduce the need for method validation when using harmonized procedures.

Process of proving that cleaning procedures effectively remove product residues, cleaning agents, and potential contaminants to acceptable levels. This ensures that equipment used in pharmaceutical and biotechnology manufacturing does not cross-contaminate subsequent batches. Effective cleaning validation helps to ensure compliance, patient safety, and audit readiness.