Sacubitril Calcium BP EP USP Pharma Grade: Properties, Structure, and Detailed Description

What is Sacubitril Calcium BP EP USP Pharma Grade?

Sacubitril Calcium BP EP USP Pharma Grade serves as a vital raw material in pharmaceutical applications, developed with strict quality standards to meet compendial requirements established by BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia). This form of Sacubitril emerges as an off-white to pale yellow crystalline solid or powdered substance, depending on the batch preparation and processing environment. Each batch delivers reliable consistency, granting manufacturers an ingredient that stands up to monitoring and regulation. The chemical is not volatile and does not produce significant dust under normal handling, which reduces risks in production areas and maintains safer air quality for staff.

Products and Applications

Primary use of Sacubitril Calcium centers on its role in the creation of cardiovascular medications, especially those used to manage heart failure. Partnered most notably with valsartan, Sacubitril forms part of the angiotensin receptor neprilysin inhibitor (ARNI) combination, which has shown a positive impact in clinical studies by reducing risks associated with cardiovascular-related mortality and hospital admissions. Pharma-grade quality assures impurity profiles align with regulatory expectations, helping to protect patient safety and streamline drug approval processes. The pharma sector relies on reliable sources of this compound for medicine formulation, with demand tied directly to the growth in heart failure cases worldwide—a tough reality that puts added importance on supply chain stability and purity assurance.

Chemical Structure and Molecular Formula

Molecular structure of Sacubitril Calcium involves the calcium salt form of Sacubitril, which itself is a prodrug. The core molecule carries both carboxyl and amide group substituents, granting it physical and chemical stability required for use in solid dosage forms. The official chemical formula of Sacubitril Calcium sits as C24H25NO5.Ca, representing the single calcium ion coordinated with the organic backbone. This structure brings good solubility in compatible solvents, offering straightforward incorporation into both granulation and direct compression manufacturing processes. Chemists confirm the structure through validated techniques like IR, NMR, and Mass Spectrometry, securing proper identification for regulatory submission.

Physical Properties and Forms

Sacubitril Calcium BP EP USP Pharma Grade most often arrives as a pale yellow powder, though some suppliers offer the substance in microcrystalline or even pearlized solid forms to accommodate specific processing needs. Flake and solid block material are less common, since the texture of the powder makes it suitable for rapid dissolution and even blending. Density within the range of 1.1 to 1.2 grams per cubic centimeter presents a solid basis for weighing and formulation, and the powder flows well under proper storage, reducing possibility of caking or material loss in large scale transfer. Melting point exceeds 140°C, giving it good heat tolerance during preparation and packaging.

Specifications and Regulatory Identification

Quality assurance comes through specification sheets outlining allowable impurity levels, moisture content limits below 0.5%, and strict residual solvent thresholds as per ICH guidelines. Standard packaging sizes may include 1kg, 5kg, or 25kg drums with tamper-evident seals to avoid contamination, each labeled with origin, batch number, manufacturing and expiry date. HS Code for Sacubitril Calcium aligns with 2933.39, which covers heterocyclic compounds containing nitrogen hetero-atom(s) only. Certificates of Analysis issued with every lot document assay values typically above 99%, matching the needs of pharma formulators and regulatory inspectors alike.

Molecular Characteristics and Material Handling

Most manufacturers derive Sacubitril Calcium from established synthetic routes beginning with raw materials like amino alcohols and protected carboxylic acid derivatives. Key to consistent output is robust raw material sourcing, solvent recovery, and waste stream management to prevent environmental contamination. Finished product is neither explosive nor flammable under typical transport and use. Still, those interfacing with the compound wear gloves, goggles, and dust masks since powder contact with eyes, inhalation, or skin absorption can pose minor risks, which are well documented on accompanying MSDS sheets. Though not classified as hazardous according to major transport authorities, careful labeling and storage in cool, dry areas preserve material quality and user safety.

Safety, Hazardous Nature, and Environmental Impact

Sacubitril Calcium does not rank as a dangerous or severely hazardous chemical under standard GHS classification, although repeated or prolonged exposure can cause mild irritation. Facilities minimize accidental release through proper spill containment trays, sealed containers, and regular staff training. Waste disposal guidelines prohibit flushing residual material or water solutions down public drains, channeling rinsates to authorized chemical disposal contractors. Broad experience in scale-up and tech transfer phase of this material has taught the value of clear communication, safety data transparency, and environmental respect across production cycles, answering the growing global demand for sustainable, safe pharmaceutical ingredient manufacturing.