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Alginate/Sodium alginate/Alginic acid Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable

    • Product Name: Alginate/Sodium alginate/Alginic acid Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable
    • Factroy Site: Yudu County, Ganzhou, Jiangxi, China
    • Price Inquiry: admin@ascent-chem.com
    • Manufacturer: Ascent Petrochem Holdings Co., Limited
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    Specifications
    HS Code 890890
    Product Name Alginate/Sodium alginate/Alginic acid Pharma Grade API
    Api Type Pharmaceutical grade alginate, sodium alginate, and alginic acid
    Common Names Sodium alginate, Alginic acid, Alginate
    Synonyms Sodium alginate, Alginic acid sodium salt, Algin, Kelp alginate, Sodium polymannuronate
    Chemical Name Sodium alginate: Sodium salt of alginic acid; Alginic acid: Poly(mannuronic acid-co-guluronic acid)
    Cas Number Sodium alginate: 9005-38-3; Alginic acid: 9005-32-7
    Molecular Formula Sodium alginate: (C6H7NaO6)n; Alginic acid: (C6H8O6)n
    Molecular Weight Variable depending on degree of polymerization; typically 10,000 to 600,000 Da
    Appearance White to pale yellow or light brown powder, granules, or fibrous solid
    Odor Odorless to slight characteristic odor
    Taste Tasteless to slightly salty
    Solubility Sodium alginate soluble in water forming viscous colloidal solution; alginic acid practically insoluble in water but soluble in alkaline solutions; both insoluble in ethanol, ether, and chloroform
    Ph Sodium alginate 1% w/v aqueous solution typically 6.0 to 8.0; alginic acid dispersion acidic
    Viscosity Varies by grade and concentration; typical 1% w/v sodium alginate solution at 20°C is 20 to 2,000 mPa·s or higher
    Assay Purity Typically 90.0% to 105.0% on dried basis according to pharmacopoeial monograph
    Sterility Injectable grade sterile; oral, tablet, capsule, and granule grades non-sterile
    Particle Size Available as fine powder, granular, or sieved grades; typical 45 to 150 µm or as specified
    Bulk Density Typical 0.3 to 0.8 g/cm³ depending on grade and particle size
    Tapped Density Typical 0.4 to 1.0 g/cm³ depending on grade
    Flowability Poor to moderate for fine powders; improved in granular grades
    Compressibility Good binding and gelling properties; used as binder and disintegrant in tablets and capsules
    Grade Pharma Grade; Oral Grade; Injectable Grade; sterile and pyrogen-free grade available
    Pharmacopoeia Compliance Complies with USP/NF, EP, BP, JP, or ChP monographs as applicable
    Application Tablet binder, capsule excipient, granule binder, controlled-release matrix, hydrogel, wound dressing, drug delivery vehicle, injectable hydrogel component
    Dosage Forms Tablet, Capsule, Granule, Injection
    Route Of Administration Oral, Injectable
    Packaging Fiber drum with PE bag inside, 25 kg net; injectable grade in sterile containers or aseptic bags
    Storage Conditions Store in a cool, dry, well-ventilated place protected from moisture and light; keep containers tightly closed
    Shelf Life Typically 24 to 36 months when stored properly in unopened containers
    Regulatory Status Pharmaceutical API/excipient manufactured under GMP; DMF/CEP may be available depending on supplier
    Origin Source Derived from brown algae such as Laminaria, Macrocystis, and Ascophyllum, or bacterial biosynthesis
    Residual Solvents Controlled according to ICH Q3C; commonly below limits
    Elemental Impurities Controlled according to ICH Q3D or pharmacopoeial requirements
    Bioburden Oral grade typically low; injectable grade controlled and monitored
    Pyrogenicity Injectable grade pyrogen-free or non-pyrogenic as specified
    Injection Suitability Injectable grade is sterile, pyrogen-free, low-endotoxin, and suitable for parenteral formulations
    Oral Suitability Oral grade is suitable for solid and liquid oral dosage forms
    Viscosity Grade Low, medium, and high viscosity grades available; e.g., 20 to 200 mPa·s, 200 to 800 mPa·s, 800 to 2,000 mPa·s or higher
    Gelling Agent Forms gels in presence of calcium ions or under acidic conditions
    Film Formation Forms films and fibers; used in wound dressings and sustained-release coatings
    Biocompatibility Generally biocompatible and biodegradable; suitable for pharmaceutical and biomedical applications
    Ph Stability Sodium alginate stable over pH 5 to 10; may precipitate at low pH
    Thermal Stability Stable at room temperature; avoid excessive heat during processing
    Chemical Stability Stable under normal storage; may degrade under strong oxidizing conditions
    Compatibility Compatible with many excipients; may interact with cationic drugs, calcium salts, and polycations
    Solubility In Organic Solvents Insoluble in ethanol, acetone, ether, and chloroform
    Water Solubility Sodium alginate freely soluble in water; alginic acid practically insoluble in water
    Salt Formation Sodium alginate is the sodium salt; alginic acid is the free acid form
    Degree Of Polymerization Variable; determines viscosity and molecular weight
    M G Ratio Ratio of mannuronic acid to guluronic acid varies by source and affects gel strength and properties
    Calcium Content Low unless calcium alginate grade; affects gelling
    Antimicrobial Preservative None typically added; preservative-free unless specified
    Antioxidant None typically added; may be stabilized with antioxidants if required
    Color White to off-white or pale yellow
    Form Powder, granule, or fibrous
    Angle Of Repose Typically 30 to 50 degrees depending on grade
    Moisture Sorption Hygroscopic; absorbs moisture from air
    Viscosity Stability Viscosity may decrease upon prolonged storage or heating
    Sterilization Method Injectable grade may be sterilized by aseptic processing or filtration; terminal sterilization may affect viscosity
    Sterility Assurance Level SAL 10^-6 for sterile injectable grade
    Pyrogen Limit Passes pyrogen test as per pharmacopoeia for injectable grade

    As an accredited Alginate/Sodium alginate/Alginic acid Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

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