Erythromycin, 6-O-methyl-, 4-O-beta-D-galactopyranosyl-D-gluconate (salt) stands out as a modified macrolide antibiotic compound, developed from the well-documented base of erythromycin. Its chemical framework features a 6-O-methyl modification alongside a galactopyranosyl-gluconate sugar segment conjugated at the 4-O position, contributing to its distinct characteristics as both a pharmaceutical ingredient and research material. The molecular formula for this compound varies with the counter-ion present, often appearing as a sodium or potassium salt for better water solubility and easier handling in both lab and industrial environments. This modification to the erythromycin scaffold not only influences solubility and antimicrobial activity but also tunes the compound’s interaction profile with various substrates and excipients in formulation science.
The presence of methyl and sugar moieties doesn’t just make a difference on paper. Modifications like these tend to change the molecule’s polarity, absorption behavior, and even the range of bacterial strains it can suppress. In my time working on formulation projects, handling chemically modified erythromycins showed clear impacts—both in terms of powder flow during manufacturing and the final product’s shelf stability. Density, hygroscopicity, and reaction with common solvents tell the handler what to expect during mixing or solution preparation.
Manufacturers and suppliers frequently offer Erythromycin, 6-O-methyl-, 4-O-beta-D-galactopyranosyl-D-gluconate (salt) in various physical forms, including solid flakes, powder, pearls, and occasionally as a crystalline solid or aqueous solution. I have seen how the physical form can make or break a development batch. Fine powders produce good dispersions in liquids, but they generate dust, which isn’t just messy—it represents loss and could be a safety hazard if handled without proper ventilation. Flakes or pearls are easier to weigh and often show less caking over time, a boon when handling in humid climates. Crystalline solids generally exhibit more defined melting points, typically indicating higher purity. Density typically ranges above 1 g/cm³, with variances depending on hydration state and crystal morphology. As a rule, maintaining low water content helps in long-term storage, resisting degradation and reducing clumping in bulk containers.
Physical characteristics stretch beyond handling. Raw material quality gets dented if suppliers slip on storage conditions during shipping, leading to fatally flawed batches. The compound’s surface area, porosity, and particle size distribution all affect dispersibility in solution or matrix. Some forms dissolve easily in ethanol or water (when counter-ions favor ionization), while others dissolve reluctantly, requiring stirring, gentle heating, or co-solvents. These processing quirks shape the usability of the product in both research-scale and full industrial operations.
The molecular structure of Erythromycin, 6-O-methyl-, 4-O-beta-D-galactopyranosyl-D-gluconate (salt) showcases the classic 14-membered lactone ring of erythromycin, adorned with a methyl group at the 6-O position, which makes it less susceptible to acid-mediated degradation in the stomach—an advantage found through hard lessons in antibiotic formulation. Attachment of the 4-O-beta-D-galactopyranosyl-D-gluconate segment creates additional hydrogen-bonding sites, influencing how the molecule interacts with solvents and other molecules. This impacts not only the molecular weight, which surpasses 1000 g/mol in its salt form, but also its partition coefficient and permeability.
I have spent years working alongside analytical teams, so it’s natural to check data like melting point (often above 120°C for the crystal, though this depends on hydrate form), specific rotation, and solubility parameters. We count on these hard numbers to predict batch-to-batch consistency and see shifts if someone slips up in the synthetic route. The empirical formula and HS Code (Harmonized System Code) play a role in global trade, giving customs groups and supply chain teams a handle for legal import and export, while also standardizing reporting in regulatory documentation. Exact codes depend on national databases, though antibiotics of this class often use 2941.10 or similar.
Every specification sheet I’ve encountered spells out appearance, purity by HPLC (often over 98% for pharmaceutical applications), water content, and assay. Typical bulk shipment containers hold around 25 kg of the raw material solid, with smaller samples available in jars or vials for research labs. Specifications also flag impurities and hazardous degradants.
Handling safety starts with knowing the basic chemical hazards. The molecule belongs to the macrolide antibiotic class, and, though effective as a pharma ingredient, exposure can trigger allergic reactions, especially in sensitive individuals. As a raw material, it’ll irritate eyes and mucosa if airborne dust becomes a problem. Standard practice involves gloves, goggles, and, for heavier duty work, respirators. It’s not just about personal safety—I’ve watched operators lose valuable material through cross-contamination of equipment or poor cleaning, driving up costs and risking batch rejection.
The material qualifies as harmful if inhaled, swallowed, or with skin contact, based on product safety data sheets. Waste disposal must comply with chemical waste regulations due to antibiotic content, avoiding unintentional environmental contamination and antibiotic resistance selection.
Manufacturing this modified erythromycin salt calls for several high-purity raw materials: parent erythromycin, methylating agents (for the 6-O position), activated galactopyranosyl and gluconic acid derivatives for the glycosylation step, and high-quality base (such as sodium or potassium hydroxide) for neutralization into the salt form. Getting clean raw materials sets the ground rules for a low-impurity final product. Inconsistent precursors yield out-of-specification batches, which create recall issues and dent plant profit margins.
Regulations on antibiotics keep shifting as resistance trends emerge globally. Production runs must stay within GMP (Good Manufacturing Practice) guidelines, and downstream users rely on transparent sourcing. Finished product labels and documentation need to clearly cite molecular formula, batch number, HS Code, net weight, and hazard identifiers. Compliance isn’t just for bureaucrats; I have seen regulatory inspectors flag non-compliance on packaging or paperwork, bringing production floors to an expensive halt.
Quality assurance hinges on frequent analytical testing. Investing in reliable HPLC, mass spectrometry, and automated water content analysis pays for itself, protecting supply chains and keeping client trust high. Automatic closed handling systems can reduce dust hazards and minimize contact risk for operators. Packaging in moisture-barrier bags or drums lined with desiccant helps manage storage and shelf life, especially in regions with high humidity.
Training remains key for both production staff and downstream handling teams. Proper education about the risks and safe management practices goes a long way—much further than compliance checklists alone. On the environmental side, closed waste management systems and validated deactivation protocols mean spent or spilled material leaves no trace in local waterways or landfill.
For product development, early consultation with regulatory experts and documentation teams saves endless headaches. Nailing raw material quality, shipping condition monitoring, and clear communication between sourcing and QA teams tightens up overall performance, keeps costs competitive, and ensures that the finished product reaches patients or researchers safely and in top condition.
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