| HS Code | 265605 |
| Product Name | LACTEL 50:50 DL-PLG (B6010-1) Biomedical PLGA Copolymer |
| Catalog Number | B6010-1 |
| Composition | 50:50 D,L-lactide-co-glycolide |
| Cas Number | 26780-50-7 |
| Form | Powder |
| Color | White to off-white |
| Inherent Viscosity | 0.55-0.75 dL/g in HFIP |
| Molecular Weight Mw | 50,000-75,000 Da |
| Glass Transition Temperature Tg | 45-50 °C |
| Solubility | Soluble in dichloromethane, chloroform, ethyl acetate, DMF, DMSO |
| Storage Temperature | -20 °C |
| Residual Monomers | <1.0% |
| Water Content | <0.5% |
| Heavy Metals | <10 ppm |
| Residue On Ignition | <0.1% |
As an accredited LACTEL 50:50 DL-PLG (B6010-1) Biomedical PLGA Copolymer factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Supplied as 1 g in an amber glass vial, sealed under nitrogen, with desiccant and foil pouch for moisture protection. |
| Container Loading (20′ FCL) | 20′ FCL: LACTEL 50:50 DL-PLG (B6010-1) Biomedical PLGA Copolymer, packed in sealed drums, palletized, moisture-protected, and shipped under controlled conditions. |
| Shipping | LACTEL 50:50 DL-PLG (B6010-1) is shipped as a non-hazardous, non-regulated solid at ambient temperature in sealed, moisture-resistant containers. It should be protected from heat, moisture, and light. No special transport labels are required. Upon receipt, store at -20°C under dry conditions. Handle in accordance with good laboratory practices. |
| Storage | Store in a tightly sealed container at -20°C, preferably under dry inert gas (nitrogen or argon). Protect from moisture, light, and heat. Keep in a desiccator to prevent hydrolysis; allow vials to equilibrate to room temperature before opening to avoid condensation. Avoid repeated freeze-thaw cycles. For short-term handling, keep cool and dry. |
| Shelf Life | Shelf life is typically 24 months when stored desiccated at −20°C, protected from moisture, heat, and light. |
For microsphere-based long-acting injectable formulations, LACTEL 50:50 DL-PLG (B6010-1) is processed by oil-in-water emulsion-solvent extraction rather than melt pelletizing because the amorphous 50:50 DL-PLG architecture must remain below its glass transition during particle solidification. In a production-scale batch, the copolymer is dissolved in dichloromethane at a concentration between 10% w/w and 20% w/w depending on target dispersed-phase viscosity; the drug substance is either co-dissolved for hydrophobic payloads or dispersed as a micronized solid for solid-in-oil-in-water processing. Emulsification is performed with a rotor-stator homogenizer operating between 5,000 rpm and 15,000 rpm, and droplet size is reduced further by transfer into an aqueous poly(vinyl alcohol) continuous phase under axial-flow impeller agitation. The controlling conflict in this process is the inverse relationship between residual solvent and burst release: a hard, solvent-depleted particle shell reduces dichloromethane retention but can shrink surface pores and delay water ingress, whereas rapid solvent extraction may leave a porous crust that elevates the first-hour release percentage. Polymer-to-drug mass ratios are adjusted between 10:1 and 30:1 when the API is a highly potent peptide or small molecule, but the actual ratio is formulation-specific and requires release screening. Residual dichloromethane is measured by headspace gas chromatography according to USP 467, with the ICH Q3C Class 2 limit of 6.0 mg/day guiding the final drying endpoint. Particle size distribution is verified by laser diffraction under ISO 13320:2020; in-process photomicrographs of internal morphology are generated by scanning electron microscopy after cryofracture. Sterilization of the finished microspheres is commonly attempted with gamma irradiation at 25 kGy, but the ester-terminated B6010-1 backbone can undergo chain scission under irradiation, shifting molecular weight distribution and accelerating release; terminal sterilization therefore requires dose-mapping and post-irradiation dissolution testing rather than a fixed release specification. The raw resin should be dried under vacuum at 25 °C for at least 24 h after exposure to relative humidity above 60%, because sorbed water participates in ester hydrolysis during both solvent-based and melt-based processing. Batch-to-batch variance in inherent viscosity is a practical limitation: release rates from microspheres with identical sieve fractions may differ when the starting copolymer molecular weight shifts, so a dissolution test using a USP apparatus 4 flow-through cell is used to align each lot with the reference profile. The terminal product is a sterile lyophilized cake of microspheres in a vial, reconstituted with an aqueous vehicle and administered through a 21-gauge needle.
In situ forming implants based on B6010-1 use N-methyl-2-pyrrolidone or dimethyl sulfoxide as water-miscible solvent, with polymer content typically between 30% w/w and 50% w/w to produce a syringeable viscous solution. The injection force through a 21-gauge needle rises nonlinearly as polymer content exceeds 40% w/w; for a fixed needle length, pressure drop is measured on a universal tensile testing apparatus equipped with a syringe compression fixture. When the solution contacts phosphate-buffered saline at 37 °C, countercurrent water ingress and solvent egress initiate liquid-liquid phase separation, forming a two-layer depot: a dense, solvent-lean outer skin and a solvent-rich interior that continues to consolidate over 24 h to 48 h. Rapid N-methyl-2-pyrrolidone loss solidifies the outer shell but can capture residual solvent pockets inside the implant, creating an uneven release surface. The critical compositional variable is plasticization of the 50:50 DL-PLG matrix by the organic solvent, which lowers the glass transition from approximately 45–50 °C toward body temperature. Compliance during development requires evaluation of residual N-methyl-2-pyrrolidone according to ICH Q3C because NMP is listed as a Class 2 solvent with a permitted daily exposure of 5.3 mg/day; analytical quantification is by gas chromatography per USP 467. Biological evaluation follows ISO 10993-1:2018, with implantation tests under ISO 10993-6:2016 and local tolerance endpoints. The end product is a single-use prefilled syringe or vial containing the sterile polymer-solvent solution, which is injected subcutaneously or intramuscularly and forms a monolithic depot in situ.
When nanoparticle drug delivery is the intended route, B6010-1 is processed by nanoprecipitation or emulsion-diffusion rather than high-shear emulsification alone. A typical organic phase contains the copolymer and a poorly water-soluble drug in acetone, ethanol, or a water-saturated ethyl acetate mixture; the organic phase is injected into an aqueous stabilizer solution of poloxamer 188, poly(vinyl alcohol), or polysorbate 80 under controlled stirring. Particle size is governed by the solvent-to-water diffusion coefficient, the polymer concentration in the solvent phase, and the phase ratio; for intravenous candidate formulations, the hydrodynamic diameter is commonly maintained below 200 nm to avoid splenic filtration. The ester-terminated character of B6010-1 makes it preferable to acid-terminated alternatives when the encapsulated payload contains amine or peptide groups that are susceptible to acylation at low pH. The nanoparticle dispersion is concentrated by tangential-flow filtration or ultracentrifugation, then lyophilized with a cryoprotectant such as trehalose at a cryoprotectant-to-polymer mass ratio near 1:1 to prevent aggregation during reconstitution. Residual moisture after lyophilization is measured by coulometric Karl Fischer titration and is typically controlled below 5% w/w because higher water content reduces the storage stability of the amorphous PLG matrix. Particle size and zeta potential are measured by dynamic light scattering and electrophoretic light scattering according to ISO 13320:2020 and ISO 13099-2:2012, respectively. Sterility is evaluated by USP 71, bacterial endotoxin by USP 85, and particulate matter by USP 788. The end product is a sterile lyophilized nanoparticle powder for reconstitution with water for injection or isotonic saline, with a nominal dose adjusted for surface-associated drug.
B6010-1 is extruded into monolithic rods, pellets, or calendered sheets for subcutaneous implantation when twin-screw compounding replaces solvent casting. The amorphous 50:50 DL-PLG has no crystalline melting transition, so thermal processing is conducted close to the glass transition, with barrel zone temperatures generally profiled below 100 °C and the die head held just above the glass transition of 45–50 °C. A co-rotating intermeshing twin-screw extruder with gravimetric feeding, vacuum venting below -0.08 MPa, and strand die geometry is typical for continuous compounding; for small preclinical batches, a laboratory-scale conical twin-screw mixer with a recirculation channel is used. The polymer must be vacuum-dried at 25 °C for 48 h before extrusion because sorbed moisture causes bubble formation and melt viscosity reduction. Drug loading is limited by the plasticization response: a poorly water-soluble API at 10% w/w to 30% w/w can be melt-dispersed, but loadings above 40% w/w frequently reduce extrudate strand integrity and produce die-face build-up. Mechanical evaluation of extruded rods is performed according to ASTM D638-14 with adaptation for small-diameter specimens, and in vivo implantation of the finished rod requires ISO 10993-5:2009 cytotoxicity assessment and ISO 10993-6:2016 local tissue response evaluation. The extrudate is oriented by controlled strand tension to reduce internal voids, then cut into rod segments of defined length using a rotary cutter with cooled blades to avoid frictional heating. Final residual solvent is not relevant for this melt route if no solvent is used, but water content is verified by Karl Fischer titration before packaging under nitrogen in heat-sealed barrier pouches. The end product is a terminally sterile implant rod delivered with a trocar or a preloaded insertion device.
| Solvent | ICH Q3C class | Permitted daily exposure | Analytical method | Process route |
| Dichloromethane | Class 2 | 6.0 mg/day | USP 467 GC-HS | Microsphere, spray coating |
| N-Methyl-2-pyrrolidone | Class 2 | 5.3 mg/day | USP 467 GC | In situ forming implant |
| Chloroform | Class 2 | 0.6 mg/day | USP 467 GC-HS | Porous scaffold casting |
| Tetrahydrofuran | Class 2 | 7.2 mg/day | USP 467 GC-HS | Nanoparticle precipitation |
| Acetone | Class 3 | 50 mg/day | USP 467 GC | Nanoparticle precipitation |
| Ethyl acetate | Class 3 | 50 mg/day | USP 467 GC-HS | Spray coating |
B6010-1 is applied as a drug-eluting absorbable coating on metallic or polymeric implant surfaces by ultrasonic spray coating followed by low-temperature vacuum drying. The coating solution typically combines the copolymer and a lipophilic API in ethyl acetate or dichloromethane at a polymer concentration of 2% w/v to 8% w/v, with a polymer-to-drug mass ratio from 3:1 to 9:1 to balance coating adhesion and release rate. Ultrasonic nozzles operating at 25 kHz to 120 kHz generate droplets with median diameters below 50 μm, allowing layered deposition and minimizing coalescence defects on complex geometries. The main process failure is edge webbing: excess solvent accumulation on curved regions produces thick, brittle rims that crack under physiological flexural loading. Coating thickness is measured by optical or stylus profilometry, and adhesion is evaluated by a tensile pull-off test following ASTM D4541-17 adapted for curved specimens. Residual ethyl acetate is controlled under the ICH Q3C Class 3 limit of 50 mg/day and measured by gas chromatography with headspace sampling; if dichloromethane is used, the Class 2 limit of 6.0 mg/day applies. For blood-contact devices, the finished coating must undergo hemocompatibility evaluation according to ISO 10993-4:2017, including complement activation and thrombogenicity endpoints. Particulate matter from the coating is monitored using USP 788 for injectable components. The end product is a coated implant, such as a cardiovascular stent, bone fixation pin, or wound closure device, with an absorbable polymer coating intended to release an antiproliferative or antimicrobial agent locally.
Salt-leached porous scaffolds from B6010-1 are produced by solvent casting and particulate leaching when rapid resorption is required for soft-tissue void filling or drug-releasing wound contact. The copolymer is dissolved in chloroform or dichloromethane at 5% w/v to 15% w/v, mixed with sodium chloride or sucrose particles sieved to a defined size fraction, cast into molds, and dried under controlled airflow. The salt-leached scaffold is then soaked in deionized water for 24 h to 48 h, with water changes every 6 h to remove the porogen. The resulting pore architecture is interconnected but heterogeneous, with pore size governed by the sieved salt fraction and pore throat size governed by salt packing density. Mechanical properties are lower than those of semi-crystalline poly(L-lactide) scaffolds, so the 50:50 DL-PLG scaffold is not indicated for load-bearing defects; it is used as a cell carrier or drug-releasing void filler in soft-tissue or bone graft adjunct applications. Compliance for this application includes ISO 10993-5:2009 for cytotoxicity, ISO 10993-6:2016 for implantation, and ISO 10993-10:2021 for sensitization; if the scaffold is manufactured in a cleanroom, the environment is validated according to ISO 13485:2016. The end product is a freeze-dried or vacuum-dried porous scaffold supplied in a sterile pouch and hydrated immediately before surgical placement.
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LACTEL 50:50 DL-PLG (B6010-1) is an ester-terminated poly(DL-lactide-co-glycolide) supplied as a white to off-white powder for biomedical matrix applications. The catalogue designation B6010-1 identifies the standard-viscosity member of the 50:50 DL-PLG series; the same comonomer ratio is also available with acid end caps and with lower or higher inherent viscosity grades for different release and processing requirements. The 0.55–0.75 dL/g inherent viscosity window of B6010-1 is commonly selected when the formulation requires enough chain length to form coherent microspheres, films, rods, or foamed scaffolds without creating excessively high solution viscosity for sterile filtration of process intermediates. In pharmaceutical development, the material is used as a biodegradable carrier in injectable microspheres, subcutaneous implants, intraocular drug delivery matrices, and tissue-engineering scaffolds produced by solvent casting, electrospinning, or melt processing. Because PLGA degrades by bulk hydrolysis, the polymer must be handled as a moisture-sensitive intermediate; storage below -20 °C in sealed desiccated containers is standard.
The release profile of B6010-1 is controlled through the certificate of analysis, which should report the DL-lactide:glycolide ratio, inherent viscosity, end-group functionality, residual monomer, residual solvent, and moisture content. The nominal molar ratio is 50:50 DL-lactide:glycolide, but the accepted batch-specific ratio may be specified as a narrow band around the nominal value; measurement is by proton nuclear magnetic resonance integration. Inherent viscosity is specified at 0.55–0.75 dL/g using a dilute-solution capillary viscometry method aligned with ISO 1628-1:2021 for polymer solution viscosity. The glass transition temperature of dry 50:50 PLGA typically lies between 40 °C and 50 °C by differential scanning calorimetry; the exact value changes with residual solvent and thermal history. Residual moisture is normally determined by Karl Fischer titration, and melt processing should not begin when moisture exceeds 0.2 wt%. Residual solvent limits are not fixed by the polymer grade alone; they must be set against the intended finished-device monograph or ICH Q3C criteria.
| Parameter | Specification / typical value | Reference method or standard |
|---|---|---|
| Comonomer ratio | 50:50 DL-lactide:glycolide nominal | 1H NMR |
| End group | Ester-terminated | Manufacturer CoA |
| Inherent viscosity | 0.55–0.75 dL/g | ISO 1628-1:2021-aligned capillary viscometry |
| Glass transition | 42–50 °C dry polymer, batch-dependent | DSC at 10 °C/min |
| Residual moisture | Below 0.2 wt% before melt processing | Karl Fischer titration |
| Storage | -20 °C in desiccated sealed container | Manufacturer storage recommendation |
The ester terminal group in B6010-1 reduces the initial concentration of free carboxylic acid relative to the acid-capped analogue B6001-1. This difference influences early-stage hydrolysis in aqueous media and can extend the induction period before appreciable molecular weight loss is observed. In emulsion-based microencapsulation, an acid-capped PLGA of the same 50:50 ratio and 0.55–0.75 dL/g viscosity may generate a more acidic polymer phase immediately after solvent evaporation, which can affect acid-labile active pharmaceutical ingredients. B6010-1 does not completely prevent acid generation; once water diffuses into the matrix and cleaves ester bonds, new terminal carboxyl groups are formed and autocatalysis proceeds. The practical benefit is a more neutral starting condition for the organic phase and often a more reproducible early-release phase when the formulation is transferred from laboratory to controlled-environment manufacturing.
Hydrolytic degradation of B6010-1 follows bulk erosion rather than surface erosion because water diffusion into the amorphous polymer phase is rapid compared with ester hydrolysis. At 37 °C, water uptake plasticizes the matrix and lowers the effective glass transition below the incubation temperature, increasing chain mobility. The 50:50 ratio contains enough glycolide to make the polyester amorphous and hydrolytically labile; degradation is faster than 75:25 or 85:15 PLGA because the higher glycolide content increases the density of relatively hydrophilic glycolate ester units. For comparative in vitro degradation tests, protocols often follow ASTM F1635-16 in phosphate-buffered saline at 37 °C; however, the measured molecular weight half-life is not a single-valued property of the polymer because geometry, porosity, and medium exchange rate alter internal acid accumulation. Dense implants can develop a low-pH core and undergo faster internal chain scission than the surface, while thin films and fine microspheres allow acid diffusion and degrade more uniformly.
Compared with semicrystalline poly(L-lactide-co-glycolide) grades, B6010-1 remains amorphous after solvent casting and compression molding because the DL-lactide sequence disrupts stereoregular chain packing. This lowers modulus and strength relative to lactide-rich grades, but it removes crystallinity-driven phase separation and spherulite formation during drying. For lipophilic drugs, the amorphous matrix can reduce crystallization-induced drug exclusion; for hydrophilic drugs, the bulk erosion pattern can create continuous release pathways rather than surface-limited diffusion. The trade-off is a shorter load-bearing window, which makes B6010-1 less suitable for orthopedic fixation devices where 85:15 PLGA or poly(L-lactide) is selected for retaining mechanical strength over several months.
| Grade / product | Comonomer ratio | End group | Inherent viscosity | Processing consequence |
|---|---|---|---|---|
| B6001-1 | 50:50 | Acid | 0.55–0.75 dL/g | Higher initial acidity; faster early hydrolysis; acid-labile actives may require buffering excipients |
| B6010-1 | 50:50 | Ester | 0.55–0.75 dL/g | Reduced initial carboxylic acid; more neutral organic phase; slower early release induction in some systems |
| B6010-2 | 50:50 | Ester | 0.15–0.25 dL/g | Lower melt viscosity and slower solvent evaporation; short-chain release kinetics; used for fine microspheres |
| B6010-5 | 50:50 | Ester | 0.45–0.55 dL/g | Intermediate viscosity; useful when 0.55–0.75 dL/g creates excessive atomization backpressure |
| Lactide-rich PLGA | 75:25 or 85:15 | Ester | Grade-dependent | Slower degradation; increased strength retention; may be semicrystalline at higher L-lactide content |
Gel permeation chromatography of B6010-1 samples often shows a unimodal molecular weight distribution with a polydispersity index between 1.5 and 2.0, typical for linear PLGA produced by ring-opening polymerization. A shoulder or broadening at the low molecular weight tail is taken as evidence of hydrolytic or thermal degradation during storage or processing. In manufacturing, incoming-lot GPC overlays are compared at fixed retention time windows; a shift in the main peak below the accepted window can cause faster release and lower microsphere yield. Because the polymer is amorphous, the GPC signal is not confounded by crystalline dissolution issues that can occur with L-lactide-rich PLGA.
For hot-melt extrusion and injection molding, B6010-1 must be dried before heating. Vacuum drying at 25–30 °C for 12–24 h or use of a desiccant dryer with a dew point below -40 °C is common; Karl Fischer titration should confirm moisture below 0.2 wt%. Melt processing temperatures for this viscosity grade are generally restricted to 100–140 °C, and residence time should remain below 5 min. Above 150 °C, thermal chain scission and ester interchange accelerate, causing a measurable reduction in molecular weight and a decrease in melt strength. Twin-screw extruders with L/D ratios between 25:1 and 40:1, vented barrels, and low-shear screw profiles are preferred for drug-polymer blends because they limit stagnant zones and provide controlled temperature uniformity. Injection molding machines used with B6010-1 require low-compression screws and back pressures that avoid excessive shear heating; melt temperature should be monitored at the nozzle rather than inferred from barrel set points.
In solvent-based microsphere and nanoparticle manufacturing, B6010-1 is dissolved in dichloromethane or chloroform at polymer concentrations commonly between 5 wt% and 20 wt%, depending on target particle size and emulsion rheology. Single-emulsion oil-in-water processing is used for poorly water-soluble active pharmaceutical ingredients, while double-emulsion water-oil-water processing is required for water-soluble peptides and proteins. High-shear homogenization or rotor-stator dispersion at 5 000–15 000 rpm is used to form the primary emulsion; the median particle size is then controlled by the shear rate, continuous-phase viscosity, and the ratio of polymer solution to aqueous phase. Solvent extraction with cold water or ethanol reduces hardening time and can produce a denser particle skin, while slow solvent evaporation tends to produce a more porous interior. A batch at the lower end of the 0.55–0.75 dL/g specification may require an increase in polymer concentration or a reduction in homogenizer speed to maintain the same particle size distribution as a batch at the upper end.
Electrospinning of B6010-1 from chlorinated solvents produces nonwoven fibrous mats for soft-tissue scaffolds; solution concentration must be adjusted with conductivity and vapor pressure to avoid bead formation. Salt-leaching and phase-inversion methods produce open-pore constructs, but residual salt or solvent must be reduced to accepted biomedical limits. In all of these routes, the polymer’s inherent viscosity affects the transition from droplet or jet to solid fiber or particle. Tight incoming-lot viscosity control below the 0.55–0.75 dL/g range is therefore more important than exact molecular weight averaging in routine production.
Residual lactide and glycolide monomer in B6010-1 should be verified against the certificate of analysis before use in injectable formulations. Elevated monomer content can plasticize the matrix, reduce glass transition temperature, and increase the initial burst release. Residual chloroform or dichloromethane is controlled by gas chromatography; the applicable limit depends on route of administration and is typically taken from ICH Q3C or pharmacopoeial general chapters. Vacuum drying after microsphere fabrication at 25–30 °C for 12–48 h reduces solvent content, but drying protocols must be balanced against particle aggregation and surface film formation.
Terminal sterilization of B6010-1-containing implants and microspheres requires dose-setting studies because gamma irradiation at normal doses can reduce molecular weight and alter release. A reference dose of 25 kGy, applied under ISO 11137-1:2006 with dose setting per ISO 11137-2:2013, may produce chain scission and free-radical oxidation in the polyester. The extent of degradation depends on moisture, oxygen, antioxidant content, and packaging density; dose mapping in loaded containers is necessary to avoid regions of local overdosing. Ethylene oxide sterilization is an alternative but the polymer must be degassed to meet residual ethylene oxide and ethylene chlorohydrin limits under ISO 10993-7:2008. Aseptic processing of the final solid is not feasible for most melt-processed or solvent-cast matrices; filtration of the polymer solution may be used before particle hardening, but terminal sterilization decisions must be integrated with in-process bioburden control.
Storage and handling of B6010-1 after terminal sterilization should preserve the low moisture content achieved during drying. Sealed glass or foil pouches are held at -20 °C; containers are brought to room temperature before opening to prevent condensation. Repeated freeze-thaw cycles increase water adsorption and should be avoided. For finished biomedical devices, the biological safety of the polymer cannot be certified solely by the polymer supplier; the final device must be evaluated under ISO 10993-1:2018, with test selection based on contact duration and tissue type. Cytotoxicity, sensitization, irritation, and implantation tests are commonly required for a subcutaneously implanted microsphere or rod. Residual solvent and monomer levels are part of the finished-product specification, not the raw-polymer CoA alone.
