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| Product Name | PEG 400 Solubilizer, Pharmaceutical Grade, Low Peroxide Content |
| Catalog No. | ATR-SDS-0030 |
| Description | High-purity polyethylene glycol 400 (PEG 400) liquid solubilizer for pharmaceutical research, drug formulation development, and solubilization of poorly water-soluble compounds in cell-based and in vivo studies. PEG 400 is a low molecular weight (average 380-420 Da) hydrophilic polymer liquid at room temperature with excellent solubilizing capacity for hydrophobic small molecules through hydrogen bonding and hydrophobic interactions. This pharmaceutical-grade product features low peroxide (<5 ppm), low aldehyde (<10 ppm), and low water (<0.5%) content, meeting USP/NF and EP monograph specifications for excipient use in preclinical formulation development. |
| Intended Use | Solubilization of hydrophobic drug candidates for in vitro and in vivo pharmacokinetic studies; co-solvent in preclinical formulation development; vehicle for oral, topical, and parenteral (appropriately diluted) administration in animal studies. |
| Principle / Technology | PEG 400 acts as a co-solvent through hydrogen bonding between ether oxygens of PEG chain and polar groups of solute; hydrophobic ethylene backbone interacts with nonpolar regions of guest molecules; water-miscible at all proportions enabling gradual dilution into aqueous media. |
| Detection Method | Dissolve compound in PEG 400 at desired concentration (typically 10-50 mg/mL for screening); vortex or sonicate; for in vitro: dilute PEG 400 stock into assay medium (final PEG 400 ≤0.1-1% v/v); for in vivo: dilute with saline or 5% dextrose to final PEG 400 ≤40% v/v; include vehicle control. |
| Sample Type | Hydrophobic small molecule drug candidates, natural products, lipophilic fluorescent probes, fat-soluble compounds. |
| Performance Range / Specifications | Solubility enhancement of 10-1000 fold vs. aqueous buffer; typical compound loading 1-100 mg/mL in neat PEG 400; stable solutions at room temperature for months for most compounds. |
| Sensitivity / LOD | Water content <0.5% by Karl Fischer; peroxide <5 ppm; ethylene oxide <1 ppm; 1,4-dioxane <10 ppm; aldehydes <10 ppm. |
| Specificity | PEG 400 is a universal solubilizer; potential for nonspecific effects in cell-based assays at >1% v/v; some cell lines (particularly primary hepatocytes) are sensitive to PEG-induced osmotic effects. |
| Reaction Conditions / Protocol | PEG 400 is chemically stable and inert under normal storage and use conditions; avoid strong oxidizing agents which may generate peroxides. |
| Components / Formulation | Polyethylene glycol 400 (average MW 380-420 Da), stabilized with BHT (butylated hydroxytoluene) <100 ppm. |
| Storage Conditions | Store at room temperature (15-25 °C) in tightly closed container; protect from direct light and moisture; blanket with nitrogen if stored for extended periods after opening. |
| Shelf Life | 36 months from date of manufacture in unopened container. |
| Package Specifications | 100 mL, 500 mL, 1 L, 2.5 L HDPE or glass bottles. |
| Product Form | Clear, colorless, viscous hygroscopic liquid; mild characteristic odor; freezes at 4-8 °C (thaws without degradation). |
| Quality Control | Each lot tested for average molecular weight (380-420 Da), viscosity, hydroxyl value, water content, peroxide content, aldehyde content, pH, residue on ignition, heavy metals, and microbial limits per USP/NF. |
| Key Features | Pharmaceutical-grade per USP/NF/EP; low peroxide and aldehyde content; excellent solubilizer for hydrophobic compounds; water-miscible; low toxicity profile; suitable for preclinical formulation; chemically stable. |
| Purity | Polyethylene glycol ≥99% polymer content; ethylene glycol <0.1%; diethylene glycol <0.1%; peroxide <5 ppm; heavy metals <5 ppm. |
| Concentration | Neat liquid (~1.13 g/mL at 20 °C); typical working concentration 0.1-40% v/v depending on application. |
| Activity / Unit Definition | Solubilization efficiency varies with compound logP and hydrogen bonding capacity; optimal for compounds with MW 200-600 Da and logP 1-4. |
| Molecular Weight | Average 380-420 Da (HO(C2H4O)nH, n=8-9). |
| Source / Origin | Polymerized from ethylene oxide; pharmaceutical grade with strict control of residual monomers and degradation products. |
| pH Range / Optimal pH | Aqueous solution (5% w/v): pH 4.5-7.5. |
| Shipping Conditions | Ambient temperature; protect from moisture. |
| Expiration Date / Stability | 36 months at room temperature unopened; after opening, use within 12 months. Retest peroxide levels if product is >12 months old after opening. |
| Regulatory / Compliance | USP/NF, EP monograph compliant; for research and preclinical use. Not for human therapeutic use without additional pharmaceutical qualification. |
| Compatibility | Compatible with water, ethanol, glycerol, propylene glycol, and most polar organic solvents. Miscible with aqueous buffers at all proportions. Incompatible with strong oxidizing agents. May leach plasticizers from some plastics — use glass or HDPE containers for long-term storage. |
| Recommended Buffer System | Not applicable — neat liquid; dilute into desired buffer system. |
| Application Notes / Precautions | For in vitro assays, keep final PEG 400 concentration ≤1% v/v; run PEG 400 vehicle control at matched concentration. For in vivo oral gavage: PEG 400 up to 40% in saline or water is well tolerated in rodents. For IV administration: final PEG 400 should not exceed 10% v/v and must be sterile-filtered before injection. PEG 400 freezes at ~4 °C — thaw completely and mix before use. Do not use PEG 400 with compounds containing free primary amines as Schiff base formation may occur over time. |
| Batch-to-Batch Consistency | Average molecular weight within 380-420 Da; viscosity within ±10% of reference; peroxide <5 ppm; ethylene oxide and 1,4-dioxane within pharmacopeial limits per lot. |
For research use only, not for clinical use.
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