+8615371019725
| HS Code | 689737 |
| Appearance | Fine off-white powder |
| Color | White to off-white |
| Odor | Odorless |
| Solubility | Readily soluble in cold or hot water; practically insoluble in organic solvents such as ethanol |
| Viscosity 1 Kcl Solution | 1200-1700 centipoise |
| Ph 1 Aqueous Solution | 6.0 to 8.0 |
| Endotoxins | Meets pharmacopeial limit for pharmaceutical grade |
| Assay | 91.0% to 108.0% xanthan gum on dried basis |
As an accredited Pharmaceutical Grade Xanthan Gum factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Pharmaceutical Grade Xanthan Gum is packaged in sealed 25 kg multi-layer bags with inner polyethylene liner for purity protection. |
| Container Loading (20′ FCL) | 20′ FCL loaded with Pharmaceutical Grade Xanthan Gum, packed in sealed drums/bags, palletized and secured for safe transport. |
| Shipping | Pharmaceutical Grade Xanthan Gum ships in sealed, food-grade bags or drums to prevent contamination and moisture absorption. Standard ground or air freight is suitable, with temperature-controlled transport recommended for extreme climates. Keep packaging dry, intact, and away from direct sunlight during transit to preserve purity and product integrity. |
| Storage | Store Pharmaceutical Grade Xanthan Gum in a tightly sealed, original container away from moisture, direct sunlight, and strong odors. Keep in a cool, dry, well-ventilated area at controlled room temperature. Avoid excessive humidity and heat, which may cause caking or degradation. Ensure handling tools are clean and dry to preserve product purity and stability. |
| Shelf Life | Shelf life is typically 2–3 years when stored in a cool, dry, sealed container away from light and moisture. |
In pediatric amoxicillin trihydrate dry powder for reconstitution, USP-NF Xanthan Gum monograph and Ph. Eur. 1277 grade gum is dry-blended with sucrose at a 1:10 gum-to-diluent ratio before filling into HDPE bottles. The dry blend is passed through a 90 μm sieve to reduce wetting failure during reconstitution. After addition of 100 mL purified water at 25 °C and 30 s of manual shaking, final gum concentration ranges from 0.15 to 0.35 wt% of reconstituted volume. Low-shear viscosity measured on a Brookfield LVF viscometer with spindle 3 at 12 min−1 is 180–350 mPa·s, and calculated yield stress remains above 1.8 Pa. Sedimentation volume after 7 days is not less than 0.9 in a 100 mL graduated cylinder for amoxicillin trihydrate particles with a d50 of 45 μm. Ready-to-use aluminum hydroxide/magnesium hydroxide antacid suspensions use 0.25–0.50 wt% xanthan gum hydrated through a Silverson L5M-A rotor-stator at 4,000 min−1 for 10 min after prewetting in 2 parts glycerin to prevent fish-eye formation. Benzalkonium chloride is not added above 0.05 wt% because anionic xanthan gum interacts with cationic preservatives and may form visible flocculates. Excipient release includes USP <61> and USP <62>, with total aerobic microbial count not exceeding 1,000 CFU/g and absence of Escherichia coli. Residual solvent compliance is assessed by USP <467>; elemental impurities are screened by USP <232>/<233> against ICH Q3D oral PDE limits.
In topical gel formulations containing 0.75% metronidazole or 1% hydrocortisone, xanthan gum at 0.8–1.2 wt% forms a pseudoplastic gel without a neutralization step and without the pH drift associated with carbomer homopolymer Type A. The polymer is hydrated in demineralized water at 25 °C with an IKA RE-162 overhead stirrer at 600 min−1 for 2 h; full viscosity develops after 24 h static maturation at 4 °C. Brookfield RV spindle 6 at 20 min−1 records 8,000–15,000 mPa·s. The flow curve is fitted to the power-law model with consistency index K of 8–22 Pa·sn and flow behavior index n of 0.22–0.35. Ethanol above 30 wt% causes macroscopic syneresis within 48 h; propylene glycol at 10–20 wt% is used instead for hydroalcoholic dermal vehicles. Hard-water calcium above 50 ppm increases low-shear viscosity through ionic bridging and may produce granular texture on transfer through 0.5 mm mesh filters. Finished gels are packaged in laminated aluminum tubes; viscosity is re-checked after 90 days at 40 °C and 75% RH under ICH Q1A(R2) accelerated conditions, with acceptance at ±20% of initial value.
Because fully hydrated xanthan gum cannot be passed through 0.22 μm PVDF membrane filters without blocking at differential pressures above 0.5 bar, ophthalmic vehicles are manufactured by aseptic hydration in sterile water for injection. Xanthan gum is limited to 0.2–0.4 wt% and hydrated at 40 °C under 0.45 m/s tip speed; after cooling to 20 °C, sodium chloride 0.9 wt% is added to reach osmolarity 285–310 mOsmol/L. Low-shear viscosity at 1.0 s−1 is maintained at 12–35 mPa·s to extend precorneal residence time without lid drag. Dry gum may be pre-sterilized by gamma irradiation at 25–40 kGy with dose mapping per ISO 11137-2:2015; terminal moist heat sterilization at 121 °C for 15 min is avoided because it reduces power-law consistency index K by 10–20% in comparative tests. Endotoxin in the pre-sterilized gum is controlled to less than 0.25 EU/mg by USP <85>, and finished unit-dose blow-fill-seal containers are tested for sterility by USP <71>. Terminal products include carboxymethylcellulose-containing artificial tears and contact lens rewetting drops in polypropylene unit-dose containers.
Direct compression of theophylline extended-release matrix tablets is performed with xanthan gum at 10–30 wt%, microcrystalline cellulose 20–50 wt%, and magnesium stearate 0.5 wt% added after 3 min of pre-lubrication mixing. A 16-station rotary tablet press with 8 mm round concave tooling compresses the mixture to 80–150 N breaking force; ejection force remains below 0.6 kN when press relative humidity is below 60% RH. Over-lubrication is controlled by limiting total final mixing time to 3–5 min; extended blending with magnesium stearate above 5 min reduces gel-layer wetting and increases T80 by 20–30%. Dissolution is run according to USP <711> Apparatus 2, paddle speed 50 min−1, in 900 mL pH 6.8 phosphate buffer at 37 °C. At 10 wt% xanthan gum, erosion dominates and T80 is commonly 8–12 h; at 30 wt%, diffusion through a swollen gel layer extends T80 beyond 18 h. The hydrated gel layer reaches 1.2–2.0 mm thickness after 2 h as measured by light microscopy on cross-sectioned tablets. Wet granulation is avoided because high-shear particle size enlargement reduces gel strength and produces lot-to-lot release variability greater than 15% RSD in T80. Korsmeyer-Peppas exponent n values between 0.55 and 0.70 indicate non-Fickian release controlled by polymer relaxation and erosion. Terminal product candidates include theophylline monolithic tablets and verapamil hydrochloride sustained-release formulations; published data for specific commercial formulations is limited.
For mucoadhesive buccal films, solvent casting uses a 0.5–1.0 wt% xanthan gum aqueous phase blended with glycerol at 8–12% of polymer mass. The solution is vacuum-defoamed at 100 mbar for 30 min to eliminate air bubbles that create film defects. A micrometer-adjusted casting knife sets wet film thickness at 0.8 mm; drying at 40 °C for 6 h gives residual moisture below 10% w/w and dry film thickness of 60–120 μm. Tensile properties measured by ASTM D882-12 on a TA.XTplus texture analyzer give ultimate tensile strength of 10–25 MPa and elongation at break of 5–15%. Mucoadhesive force against porcine buccal mucosa, measured with a 25 mm cylindrical probe at 0.5 N contact force for 60 s, ranges from 15 to 30 g. Xanthan gum is combined with hydroxypropyl cellulose in a 3:1 ratio to balance mucoadhesion and flexibility; the anionic gum is not combined with chitosan above 0.1 wt% because electrostatic complexation produces immediate precipitate and casting defects. Terminal configurations include lidocaine 10 mg oral ulcer films and triamcinolone acetonide 0.1% w/w buccal adhesive patches, both packaged in cold-form foil blisters with desiccant to limit moisture uptake below 0.5% over 24 months.
Amorphous wound hydrogels are formulated with 1.2–2.0 wt% xanthan gum, 10 wt% glycerol as humectant, and 0.15 wt% sodium chloride to produce a transparent gel with storage modulus G′ of 40–120 Pa at 1 Hz and 25 °C on a strain-controlled rheometer with 40 mm parallel plates. The gel is filled into amber LDPE tubes and terminally sterilized by gamma irradiation at 25–40 kGy; dose absorption is mapped by ISO 11137-2:2015, and the finished device must maintain pH 6.0–7.5. Radiation-induced main-chain scission reduces viscosity in a dose-dependent manner, so a 10% xanthan gum overage is incorporated when assigned absorbed dose exceeds 30 kGy. Biological evaluation follows ISO 10993-5:2009 for cytotoxicity, ISO 10993-10:2010 for skin irritation, and ISO 10993-11:2017 for acute systemic toxicity; endotoxin release is governed by USP <161> for medical devices. The absence of chemical crosslinkers avoids residual monomer and initiator leachables, but the physical network collapses when polyvalent cations exceed 10 mM, which excludes calcium-containing wound cleansers. Batch records follow 21 CFR 820 design controls. Terminal products include amorphous hydrogel wound filler for dry necrotic wounds and sheet hydrogel contact layers laminated to polyurethane film backing.
Maintaining suspension homogeneity in 60% w/v barium sulfate oral contrast media requires a low-shear yield stress above 1.5 Pa. Xanthan gum is added at 0.20–0.35 wt% of final suspension and hydrated under −0.8 bar vacuum with an IKA HBR 4 digital stirrer at 800 min−1 for 20 min to deaerate simultaneously. Apparent viscosity at 50 s−1 and 25 °C is held at 150–300 mPa·s; release testing rejects batches above 400 mPa·s because excessive viscosity delays gastric emptying. A 75 μm full-pass screen is placed in the transfer line to remove undispersed gum agglomerates before bottling into 500 mL PET containers. The formulation must comply with the current USP-NF Barium Sulfate monograph and with USP <429> for raw barium sulfate particle size, where the sulfate is pre-milled to d50 2 μm. pH is adjusted with 0.1 N sodium hydroxide to 6.5–7.5. Sedimentation volume after 48 h is not less than 0.95 in a 100 mL graduated cylinder, and redispersion requires no more than 5 manual inversions. Terminal products include barium sulfate oral suspension for CT colonography and double-contrast upper gastrointestinal imaging.
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Pharmaceutical Grade Xanthan Gum is a high-molecular-weight anionic polysaccharide produced by aerobic fermentation of Xanthomonas campestris strain NRRL B-1459 or an equivalent production strain. The polymer is recovered by pasteurization, precipitation with isopropanol, mechanical dewatering, drying, and controlled milling. Supplier designations such as XG-PH-200, XG-PH-325, and XG-PH-LE denote 200-mesh, 325-mesh, and low-endotoxin pharmaceutical variants rather than compendial categories. A representative 200-mesh material passes not less than 90% through a 75 µm sieve and may show a tapped bulk density of 0.60–0.90 g/cm³. The polymer has a reported molecular weight range of 2×10⁶ to 20×10⁶ Da, with a characteristic triple-helix ordered conformation that is sensitive to ionic strength and temperature. The molecule consists of a 1,4-linked β-d-glucose backbone with trisaccharide side chains containing d-mannose and d-glucuronic acid; the pyruvic acid substitution level is compendially controlled because it influences charge density and interaction with galactomannans.
Compendial compliance is defined by the USP-NF xanthan gum monograph and Ph.Eur. 1277. Typical release specifications include pH 6.0–8.0 in a 1% aqueous dispersion, loss on drying not more than 15.0%, total ash not more than 16.0%, acid-insoluble ash not more than 1.0%, and pyruvic acid not less than 1.5% on the dried basis. Residual isopropanol is controlled below 0.075% for low-endotoxin variants and below 0.5% for oral excipient grades under ICH Q3C class 3 solvent guidance. The powder is hygroscopic and should be stored at ≤25 °C and ≤60% relative humidity in closed containers; if ambient moisture exceeds 60%, pre-drying at 60 °C for 1 h may be required to prevent caking and delayed hydration during aqueous dispersion.
Food-grade xanthan gum complies with 21 CFR 172.695, FCC, or JECFA criteria, but is not routinely tested to the harmonized pharmacopoeial limits for elemental impurities, microbial enumeration, or specified pathogens. Technical grades may contain residues of fermentation nutrients, defoamer, or recovery solvents that render them unsuitable for finished drug products. Pharmaceutical grade material must satisfy USP <232> and USP <233> elemental impurity requirements based on ICH Q3D option 1. Typical supplier certificates of analysis may report lead at ≤2 ppm, arsenic at ≤3 ppm, cadmium at ≤1 ppm, and nickel at ≤10 ppm. Microbial quality is tested by USP <61> and USP <62>: total aerobic microbial count ≤1000 CFU/g, total yeast and mold count ≤100 CFU/g, and absence of Escherichia coli, Salmonella species, and Staphylococcus aureus. Pharmaceutical grade documentation includes allergen statements, fermentation substrate origin, residual solvent data under USP <467>, and change-control notification, which are not uniformly available from food-grade or technical suppliers.
| Attribute | Technical grade | Food grade | Pharmaceutical grade |
|---|---|---|---|
| Compendial monograph | None | FCC / JECFA | USP-NF, Ph.Eur. 1277 |
| Bioburden control | Uncontrolled | Variable | ≤1000 CFU/g TAMC; ≤100 CFU/g TYMC |
| Endotoxin testing | Not performed | Not routine | USP <85>; oral grade typically ≤100 EU/g |
| Elemental impurities | Uncontrolled | Limited testing | USP <232>, USP <233>, ICH Q3D option 1 |
| Residual solvents | Variable | May meet food limits | USP <467>, ICH Q3C |
| Documentation | Minimal | Certificate of analysis | Full compendial CofA, change control, validation support |
In suspension vehicles, pharmaceutical grade xanthan gum functions as a shear-thinning suspending agent at 0.2–0.5% w/w and as a controlled-release matrix former at 5–15% w/w in direct-compression or wet-granulated tablets. The gum hydrates in cold water; full viscosity development in deionized water at 25 °C is generally achieved within 30–60 min under propeller agitation of 500–800 rpm. Dispersion should be carried out by pre-blending the powder with glycerin, propylene glycol, or another water-miscible non-solvent to separate particles, or by using an eductor to wet the powder into a high-velocity liquid stream. Once hydrated, a 1% solution in 1% potassium chloride measured on a Brookfield RVT viscometer at 20 rpm and 25 °C may show apparent viscosity of 1200–1600 mPa·s. The solution displays a power-law index n of approximately 0.20–0.35 over 0.1–100 s⁻¹ under ISO 3219 or ASTM D2196-20 procedures. High-shear rotor-stator processing above 3000 rpm should be minimized because chain scission can reduce thickening efficiency. In tablet formulations, the gum forms a gel layer on the dosage form; dissolution should be tested under USP <711> apparatus 2 at paddle speed 50 rpm when xanthan gum is used as a matrix former, because dissolution is controlled by gel-layer erosion rather than immediate disintegration.
Compared with microcrystalline cellulose/carboxymethylcellulose sodium co-processed suspending vehicles, xanthan gum provides higher aqueous viscosity per unit mass at low concentration but less thixotropy. Compared with carbomer, xanthan gum does not require neutralization to form a viscous solution; however, carbomer gels are typically clearer, and xanthan gum solutions may show turbidity from fermentation residues if not filtered. Compared with carrageenan, xanthan gum is less prone to syneresis after freeze-thaw cycling, but its response to calcium differs. Compared with acacia or tragacanth, pharmaceutical grade xanthan gum has tighter bioburden control and more reproducible lot-to-lot viscosity because fermentation and alcohol precipitation are controlled unit operations. Acacia typically requires 10–30% for emulsification, whereas xanthan gum stabilizes emulsions through continuous-phase viscosity at 0.1–0.3%.
Low-endotoxin pharmaceutical grades are evaluated by the limulus amebocyte lysate kinetic chromogenic method under USP <85> or Ph.Eur. 2.6.14. Oral excipient grades commonly carry an endotoxin limit of ≤100 EU/g. Mucosal, ophthalmic, and inhalation feasibility grades may specify ≤10 EU/g or ≤5 EU/g; each lot must be supplied with a certificate of analysis that includes the actual value and spike recovery. For sterile product development, dry-heat depyrogenation of xanthan gum powder is not recommended because carbohydrate degradation occurs above 150 °C; published data for dry-heat processing of this specific excipient is limited. Gamma irradiation above 25 kGy may reduce molecular weight and viscosity; if irradiation is used, final formulation viscosity must be confirmed rather than assumed. Preservative compatibility should be tested because xanthan gum is anionic and can interact with cationic antimicrobial agents such as benzalkonium chloride at concentrations above 0.02%, potentially reducing available preservative; antimicrobial effectiveness testing under USP <51> is required for multidose topical or oral liquids.
| Attribute | Standard or method | Typical pharmaceutical acceptance criterion |
|---|---|---|
| Apparent viscosity | Ph.Eur. 1277, USP-NF | ≥600 mPa·s for 1% solution in 1% KCl |
| pH of aqueous dispersion | Ph.Eur. 1277 | 6.0–8.0 |
| Loss on drying | USP <731> | ≤15.0% |
| Total ash / acid-insoluble ash | USP <281> | ≤16.0% / ≤1.0% |
| Pyruvic acid | Ph.Eur. 1277 | ≥1.5% on dried basis |
| Microbial limits | USP <61>, USP <62> | TAMC ≤1000 CFU/g; TYMC ≤100 CFU/g; specified pathogens absent |
| Elemental impurities | USP <232>, USP <233>, ICH Q3D | Option 1 limits for oral formulations |
| Bacterial endotoxins | USP <85> / Ph.Eur. 2.6.14 | Low-endotoxin grade ≤10 EU/g; oral grade ≤100 EU/g |
| Residual solvents | USP <467>, ICH Q3C | Isopropanol ≤0.5% or ≤0.075% by grade |
Xanthan gum maintains viscosity in the presence of many electrolytes, unlike carboxymethylcellulose sodium, which can be more sensitive to high salt. Addition of 0.1 M sodium chloride to a 1% xanthan gum solution increases low-shear viscosity and yield stress by stabilizing the ordered conformation; however, addition of calcium at 0.5% w/v may cause localized gelation or haze in unbuffered systems. Viscosity is stable between pH 4.0 and 10.0; below 3.0, acid-catalyzed hydrolysis can reduce molecular weight during long-term storage at 40 °C. The gum does not require neutralization, unlike carbomer, but it also does not produce the same high-yield transparent gel. Its shear-thinning behavior is stronger than hypromellose, providing lower viscosity during pouring and higher viscosity at rest. The ratio of apparent viscosity at 2 s⁻¹ to 50 s⁻¹ for pharmaceutical grade xanthan gum is typically 5–10, whereas hypromellose vehicles may show 2–4. Published data for direct comparisons in complex multi-component systems is limited; formulation screening should include controlled-stress rheometry rather than relying on single-point viscosity alone.
In direct-compression and wet-granulation operations, the powder should be incorporated before hydrophobic lubricants such as magnesium stearate because lubricant coatings on gum particles delay hydration. Twin-screw wet granulation using gravimetric feeders at a powder feed rate of 2–5 kg/h and liquid-to-solid ratio 0.15–0.25 can densify formulations without over-granulating; however, shear intensity must be validated because xanthan gum solutions may shear thin and recover incompletely if polymer chains are fractured. In semi-solid manufacturing, a planetary mixer with vacuum capability of -0.8 bar and sweep speed 20–40 rpm is preferable to high-speed dispersers when processing gels above 1.5% gum concentration. If air entrapment occurs, vacuum deaeration at ≤40 °C reduces bubble size without thermal degradation. For continuous oral suspension production, inline viscosity monitoring at 25 °C with a vibrating fork viscometer set to 20–100 mPa·s may be used as a process analytical technology control, but the method must be correlated to oscillatory yield stress because single-point viscosity does not capture low-shear suspension capacity.
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