For pharmaceutical manufacturers and product developers, the quality of raw materials is non-negotiable. Lidocaine Hydrochloride (CAS 73-78-9), a staple in both local anesthesia and cardiac antiarrhythmic therapies, demands rigorous adherence to quality standards. Understanding these specifications is vital for ensuring the efficacy, safety, and regulatory compliance of the final drug product.

The primary benchmark for pharmaceutical-grade Lidocaine Hydrochloride is often the United States Pharmacopeia (USP) standard, with USP36 being a commonly referenced version. This standard outlines critical parameters that must be met, including appearance, pH, optical rotation, heavy metal limits, sulphated ash content, water content, residual solvents (like acetone and butyl alcohol), and bacterial endotoxins. A typical specification for Lidocaine Hydrochloride is that it appears as a white powder without smell and possesses a bitter taste.

The assay is a crucial indicator of purity and potency. For Lidocaine Hydrochloride, the assay typically ranges from 89.5% to 102.0%. This means that a batch of the material should contain at least 89.5% and no more than 102.0% of the active Lidocaine Hydrochloride by weight, based on the specific analytical method employed.

When sourcing Lidocaine Hydrochloride, buyers should always request a detailed Certificate of Analysis (CoA) from their supplier. This document will certify that a particular batch meets the specified quality standards. It’s important to verify that the CoA aligns with USP36 or other relevant pharmacopeial standards. For instance, limits on heavy metals are typically set at ≤5ppm, and sulphated ash at ≤0.5%, ensuring minimal inorganic impurities.

Water content is another important parameter, usually specified to be between 3.1% and 4.6%. Residual solvents like acetone and butyl alcohol must also be below specified limits, often ≤0.5%, to prevent contamination and potential toxicity.

For procurement managers looking to buy Lidocaine Hydrochloride, partnering with manufacturers who can consistently provide material that meets these stringent specifications is key. While price is always a consideration, the ability of a supplier to guarantee quality and provide thorough documentation is paramount. When inquiring about Lidocaine Hydrochloride price, ensure that the quotes reflect material that meets USP standards. It's advisable to look for a reputable manufacturer that specializes in pharmaceutical intermediates and can offer stable, long-term supply agreements.

In essence, the quality of Lidocaine Hydrochloride directly impacts the performance and safety of pharmaceuticals. Diligent attention to USP specifications, assay requirements, and supplier reliability is essential for any organization involved in its procurement and formulation.