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Elemental Impurities Testing: Understanding USP <232>, USP <233>, and ICH Q3D
Elemental impurities in drug products can enter the manufacturing process through several pathways: as residual catalysts intentionally introduced during synthesis, as contaminants from interactions with processing equipment or container/closure systems, or as impurities already present in raw material components. Unlike active pharmaceutical ingredients, elemental impurities provide no therapeutic benefit to patients. In fact, they can...
Why Cleaning Validation is Non-Negotiable in Drug Manufacturing
THE FOUNDATION What Is Cleaning Validation in Pharmaceuticals - and Why Does It Matter? When pharmaceutical equipment moves from one production run to the next, the stakes could not be higher. Trace residues of active pharmaceutical ingredients (APIs), cleaning agents, or byproducts can quietly alter a drug's strength, composition, or effectiveness - putting patients at...
Understanding USP 〈311〉 Alginates Assay: Reliable Testing Support from RM Analytical
Alginates are widely used pharmaceutical excipients known for their thickening, stabilizing, and controlled-release properties. Because these materials play a critical role in product performance and quality, accurate analytical testing is essential to ensure compliance with pharmacopeial requirements and material specifications. One of the key compendial procedures used to evaluate alginate materials is USP 〈311〉 Alginates...





