2-((3Ar,4S,6R,6As)-6-Amino-2,2-Dimethyltetrahydro-3Ah-Cyclopenta[D][1,3]Dioxol-4-Yloxy)Ethanol L-Tartaric Acid BP EP USP Pharma Grade: What Is It?

Molecular Structure and Formula

Precision matters once you start working with 2-((3Ar,4S,6R,6As)-6-Amino-2,2-Dimethyltetrahydro-3Ah-Cyclopenta[D][1,3]Dioxol-4-Yloxy)Ethanol L-Tartaric Acid at the pharma grade required for BP, EP, and USP standards. The substance comes with a mouthful of a name, but a closer look at its molecular framework provides a lot of context. The backbone includes a cyclopenta[d][1,3]dioxol ring fused with dimethyl and amino groups, paired with an ethanol component, complexed with L-tartaric acid. Each element in the structure brings a function, especially in complex pharmaceutical synthesis, where stereochemistry and purity carry major weight. The molecular formula brings together carbon, hydrogen, nitrogen, and oxygen atoms in specific configurations. In the hands of chemists, these patterns form the basis for discussions around chiral purity, stability, and solubility. L-tartaric acid salt introduces chirality, influencing everything from how an active compound behaves in the body to how it stands up to regulatory scrutiny.

Material Specifications and Physical Properties

People who’ve worked with pharmaceutical-grade chemicals notice that “grade” isn’t just a label. It means every batch comes with stricter controls and documentation. This particular compound most often appears as a solid: pale flakes, crystalline powder, sometimes even as dense pearls or small granular crystals depending on the crystallization and post-processing stages the manufacturer follows. The feel can be slightly waxy, reflecting the presence of the dimethyl groups, and storage often has to keep the substance dry to avoid hydrolysis or caking. For folks handling it, density matters as powders settle differently compared to flakes and pearls, affecting everything from measuring to mixing. Specification sheets for pharma grade include more than an assay - they cover melting range, residual solvent analysis, microbial limits, and particle morphology. All those details drive what goes on in production, helping companies meet not just local but international benchmarks.

HS Code, Safety, and Hazard Information

Every time raw materials cross borders, the HS Code makes tracking, classifying, and taxation possible for customs authorities. For 2-((3Ar,4S,6R,6As)-6-Amino-2,2-Dimethyltetrahydro-3Ah-Cyclopenta[D][1,3]Dioxol-4-Yloxy)Ethanol L-Tartaric Acid, chemical importers and users lean on the HS Code to align on global logistics and paperwork, including safety disclosures. Handling brings another layer: looking at safety datasheets, this compound can be hazardous or harmful depending on processes, worker protection, and downstream usage. I remember months spent on the shop floor reviewing safety labels — “irritant,” “harmful if swallowed” — each supported by Real World scenarios in labs. Personal protective equipment moves from optional to required, especially given some amino derivatives can pose respiratory or skin exposure risks. Emergency procedures sometimes get overlooked by new hires until training drives home the consequences. Storing this chemical safely means watching temperature and moisture, plus labeling for flammability if solvents are involved.

Chemical Properties and Uses in Raw Material Supply

Chemistry teams go into detail, sometimes obsessively, over properties like solubility, pH, and reaction stability. This substance dissolves readily in water and some polar organic solvents, which improves its suitability for many syntheses. It acts as an intermediate in the creation of pharmaceutical actives, often functioning as both a building block and a chiral resolver. Dosing, scaling, and Purity Assurance come up again and again in production meetings. Each property, from the density of a dry crystal to the clarity of a solution, plays into how companies scale up from grams in the lab to kilograms for industry. Raw material buyers want not just a certificate of analysis, but assurance that every shipment aligns with regulatory standards, whether it’s headed for an oral dosage form or an injectable therapeutic. Trends in green chemistry also ask whether these starting materials come from sustainable sources, focusing on solvent use and byproducts that impact the environment.

Addressing Industry Challenges and Solutions

Tighter regulations in pharmacology have raised the bar for suppliers and buyers. Designations like BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) go beyond paperwork – inspectors want full traceability from raw material through finished product. Issues crop up with counterfeiting, substandard batches, and supply chain disruptions, prompting companies to demand both digital and physical trace trails. From my own work with regulatory teams, clear labeling, digital inventory systems, and central documentation take time to implement but stop dozens of errors and mis-shipments every month. Companies looking for better solutions invest in staff training, hygienic warehouse operations, and real-time temperature monitoring. Meanwhile, collaboration between raw material suppliers and end-users accelerates — open communication about property changes, process tweaks, and regulatory updates can mean the difference between product recalls and smooth launches.