Pharmaceutical Excipients
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pharmaceutical excipients
Ascorbic Acid (Vitamin C, Pharmaceutical Grade)
CAS: 50-81-7
Pharmaceutical grade Ascorbic Acid (Vitamin C) is used as an antioxidant stabilizer in oral, parenteral, and topical formulations to prevent oxidative degradation of susceptible APIs and excipients. It scavenges free radicals and reduces dissolved oxygen, protecting formulations during manufacturing and storage. It also finds use as a pH adjuster and as an active ingredient in nutraceutical and vitamin C supplement products.
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Benzyl Alcohol (Pharmaceutical Grade Preservative)
CAS: 100-51-6
Pharmaceutical grade Benzyl Alcohol is an aromatic alcohol used as an antimicrobial preservative and solvent in injectable, topical, and oral formulations. At concentrations of 0.9–2.0%, it is effective against a broad spectrum of microorganisms. It also provides mild local anesthetic properties that reduce injection site pain in parenteral products.
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Calcium Stearate (Pharmaceutical Grade)
CAS: 1592-23-0
Pharmaceutical grade Calcium Stearate is a calcium salt of stearic acid used as a tablet lubricant and glidant. It provides effective lubrication at concentrations of 0.5–2% and is particularly suited for formulations where magnesium ions must be avoided. It has a less pronounced negative effect on tablet hardness and dissolution compared to magnesium stearate.
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Carnauba Wax (Pharmaceutical Grade)
CAS: 8015-86-9
Pharmaceutical grade Carnauba Wax is a natural plant wax obtained from the leaves of the Brazilian Copernicia prunifera palm. In pharmaceutical manufacturing, it is used as a tablet polishing agent to impart a high-gloss finish to sugar-coated and film-coated tablets. Its high melting point (82–86°C), hardness, and water resistance also make it useful as a sustained-release matrix lipid and protective coating component.
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Cellulose Acetate Phthalate (CAP)
CAS: 9004-38-0
Cellulose Acetate Phthalate (CAP) is a widely used enteric coating polymer that remains intact in gastric acid but dissolves above pH 6.0 in the intestine. It provides effective protection of acid-sensitive APIs from gastric degradation and enables targeted drug delivery to the small intestine. It can be applied from organic solvent solutions or aqueous dispersions.
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Citric Acid (Pharmaceutical Grade)
CAS: 77-92-9
Pharmaceutical grade Citric Acid is a tricarboxylic acid used as a pH adjuster, buffering agent, chelating agent, and acidulant in a wide range of oral, parenteral, and topical formulations. Its ability to chelate divalent metal ions makes it particularly effective as a metal-sequestering antioxidant synergist. It is also an essential component of effervescent tablet formulations.
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Colloidal Silicon Dioxide (Aerosil 200)
CAS: 7631-86-9
Colloidal Silicon Dioxide (Aerosil 200) is a fumed amorphous silica with a surface area of approximately 200 m²/g, used as a glidant and adsorbent in pharmaceutical formulations. At low concentrations (0.1–0.5%), it significantly improves powder flow by reducing inter-particle friction. It is also used as a suspending agent and thickener in liquid and semisolid preparations.
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Copovidone VA64 (Kollidon VA64)
CAS: 25086-89-9
Copovidone VA64 is a copolymer of vinylpyrrolidone and vinyl acetate in a 6:4 ratio, known commercially as Kollidon VA64. It combines the excellent binding properties of PVP with the plasticizing effect of PVA, making it ideal for hot melt extrusion (HME) and spray-drying applications for amorphous solid dispersion formation. It is widely used to enhance bioavailability of BCS II and IV drugs.
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Corn Starch (Pharmaceutical Grade)
CAS: 9005-25-8
Pharmaceutical grade Corn Starch is a natural polysaccharide derived from maize, widely used as a disintegrant, binder, and diluent in tablet and capsule formulations. It swells rapidly upon contact with water, promoting tablet disintegration and drug release. It is inexpensive, widely available, and compliant with major pharmacopoeial standards.
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Croscarmellose Sodium (Ac-Di-Sol)
CAS: 74811-65-7
Croscarmellose Sodium is a crosslinked polymer of carboxymethylcellulose sodium used as a superdisintegrant in solid oral dosage forms. It provides rapid and efficient tablet disintegration through a combination of swelling and wicking mechanisms, and is effective at low concentrations (1–5%). Compliant with USP/NF, EP, and JP monographs.
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Crospovidone (PVPP)
CAS: 9003-39-8
Crospovidone (crosslinked polyvinylpyrrolidone, PVPP) is a highly efficient superdisintegrant that functions primarily through a wicking mechanism rather than swelling. It is insoluble in water and organic solvents, making it chemically stable and compatible with a wide range of APIs. It is effective at low concentrations and produces rapid, consistent tablet disintegration.
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Dibasic Calcium Phosphate (DCP)
CAS: 7757-93-9
Dibasic Calcium Phosphate (DCP) is a widely used inorganic diluent and filler for tablets and capsules, valued for its excellent compressibility and high drug loading capacity. It is chemically inert, non-hygroscopic, and compatible with most APIs. Available in both anhydrous and dihydrate forms to suit various formulation requirements.
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Ethylcellulose N10 (EC N10)
CAS: 9004-57-3
Ethylcellulose N10 is a water-insoluble cellulose ether with a 5% toluene/ethanol viscosity of approximately 10 mPa·s, used as a film coating material for sustained-release applications and as a binder in sustained-release matrix tablets. It forms robust, moisture-resistant films that are impermeable to water, enabling precise control of drug diffusion.
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Eudragit E PO (Basic Butylated Methacrylate Copolymer)
CAS: 24938-16-7
Eudragit E PO is a cationic copolymer based on dimethylaminoethyl methacrylate that dissolves below pH 5.0 in gastric fluid, making it a gastro-soluble polymer. It is widely used as a taste-masking and moisture-protective film coating for tablets and pellets. It also finds application as a binder and hot melt extrusion carrier for solubilization of poorly soluble drugs.
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Eudragit L100 (Methacrylic Acid Copolymer Type A)
CAS: 25212-88-8
Eudragit L100 is an anionic copolymer of methacrylic acid and methyl methacrylate used as an enteric coating polymer, dissolving at pH 6.0 and above. It provides reliable protection against gastric acid and enables targeted drug release in the duodenum and jejunum. It is applied from organic solvent or aqueous dispersion coating systems.
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Eudragit RS PO (Ammonio Methacrylate Copolymer Type B)
CAS: 33434-24-1
Eudragit RS PO is a water-insoluble copolymer with low permeability, based on neutral methacrylic esters with a small proportion of quaternary ammonium groups. It swells in contact with water and controls drug release through diffusion, providing pH-independent sustained release. It is commonly used in pellet and matrix tablet formulations for extended drug delivery.
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Ferric Oxide Red (Iron Oxide Red)
CAS: 1309-37-1
Pharmaceutical grade Ferric Oxide Red (Iron Oxide Red, E172) is an inorganic iron oxide pigment used as a colorant in tablet coatings, capsule shells, and pharmaceutical preparations. It provides stable, light-fast red-brown coloration and is insoluble in water, ensuring color consistency throughout the shelf life. It is also used in cosmetics and food products.
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Glycerin (Pharmaceutical Grade)
CAS: 56-81-5
Pharmaceutical grade Glycerin (glycerol) is a trihydric alcohol used extensively as a humectant, solvent, sweetener, and plasticizer in oral, topical, parenteral, and ophthalmic formulations. Its hygroscopic nature, high water miscibility, and low toxicity make it a versatile excipient for liquid and semisolid preparations. It is also used as a suppository base and as a lubricant in capsule fill operations.
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Glyceryl Behenate (Compritol 888 ATO)
CAS: 18641-57-1
Glyceryl Behenate (Compritol 888 ATO) is a mixture of glycerol mono-, di-, and tribehenate used as a lipid matrix former for sustained-release tablets and pellets, and as a lubricant in solid dosage forms. Its high melting point (65–77°C) enables melt granulation and hot melt extrusion processes. It provides pH-independent controlled release by forming a lipid barrier around the drug.
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Hydroxypropyl Cellulose LF (HPC LF)
CAS: 9004-64-2
Hydroxypropyl Cellulose LF is a low-viscosity grade of HPC with a 2% aqueous viscosity of approximately 75–150 mPa·s, primarily used as a binder in tablet and granule formulations. It dissolves in both water and organic solvents and exhibits thermoplastic properties, making it suitable for hot melt extrusion processes in addition to conventional manufacturing.
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Hydroxypropyl Methylcellulose E5 (HPMC E5)
CAS: 9004-65-3
Hydroxypropyl Methylcellulose E5 (HPMC E5) is a low-viscosity grade of HPMC with a 2% aqueous solution viscosity of approximately 5 mPa·s, widely used as a film coating agent, binder, and viscosity modifier. Its excellent film-forming properties and solubility in both water and organic solvents make it suitable for immediate-release coating and tablet binding applications.
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Hydroxypropyl Methylcellulose K4M (HPMC K4M)
CAS: 9004-65-3
HPMC K4M is a high-viscosity, sustained-release grade of hydroxypropyl methylcellulose with a 2% aqueous viscosity of approximately 4000 mPa·s. It forms a robust gel barrier upon hydration, controlling drug diffusion and enabling extended drug release profiles. It is the cornerstone excipient in hydrophilic matrix tablet technology.
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Hypromellose Acetate Succinate (HPMCAS)
CAS: 71138-97-1
Hypromellose Acetate Succinate (HPMCAS) is a cellulose derivative used as an enteric coating polymer and as a carrier in amorphous solid dispersions (ASD) for bioavailability enhancement. It dissolves above pH 5.5 to 6.8 depending on the grade (LF, MF, HF), providing targeted intestinal drug release. It is the most widely used polymer for spray-dried dispersions of poorly soluble drugs.
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Lactose Anhydrous
CAS: 63-42-3
Lactose Anhydrous is the water-free form of lactose, offering lower moisture content and superior flowability for direct compression applications. It is the excipient of choice for moisture-sensitive APIs and high-speed tableting operations. Compliant with USP/NF, EP, and JP pharmacopoeial standards.
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Lactose Monohydrate
CAS: 5989-81-1
Lactose Monohydrate is a natural disaccharide sugar widely used as a filler and diluent in tablet and capsule formulations. It provides good flow, compressibility, and compatibility with a wide range of active pharmaceutical ingredients. Available in various particle size grades to suit different manufacturing processes.
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Magnesium Stearate (Pharmaceutical Grade)
CAS: 557-04-0
Pharmaceutical grade Magnesium Stearate is the most widely used lubricant in tablet and capsule manufacturing, preventing sticking of materials to punch faces and die walls during compression. It is used at low concentrations (0.25–2%) and is compatible with a broad range of APIs. Both vegetable-derived and synthetic grades are available to meet diverse regulatory and halal/kosher requirements.
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Mannitol (Pharmaceutical Grade)
CAS: 69-65-8
Pharmaceutical grade Mannitol is a sugar alcohol excipient used extensively as a diluent and bulking agent in tablet, lyophilized, and parenteral formulations. Its low hygroscopicity, pleasant taste, and cooling sensation make it ideal for chewable and orally disintegrating tablets. Compliant with USP/NF, EP, JP, and ChP standards.
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Methylparaben (Pharmaceutical Grade)
CAS: 99-76-3
Pharmaceutical grade Methylparaben (methyl 4-hydroxybenzoate) is a widely used antimicrobial preservative in oral, topical, and parenteral formulations. It exhibits broad-spectrum antimicrobial activity and is typically used in combination with propylparaben for synergistic effect. It is effective over a wide pH range (4–8) and is soluble in water and most organic solvents.
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Microcrystalline Cellulose PH101
CAS: 9004-34-6
Microcrystalline Cellulose PH101 is a purified, partially depolymerized cellulose widely used as a binder and filler in solid dosage forms. With a fine particle size of approximately 50 µm, it offers excellent compressibility and flow properties for wet granulation and direct compression. It is a USP/NF and EP compliant excipient with proven safety and functionality in pharmaceutical manufacturing.
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Microcrystalline Cellulose PH102
CAS: 9004-34-6
Microcrystalline Cellulose PH102 is a larger-particle-size grade of MCC with a median particle diameter of approximately 100 µm, providing superior flowability compared to PH101. It is optimized for direct compression applications where blend flowability is critical. Fully compliant with USP/NF, EP, and JP monographs.
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Poloxamer 188 (Pluronic F68)
CAS: 9003-11-6
Poloxamer 188 (Pluronic F68) is a nonionic block copolymer of polyoxyethylene and polyoxypropylene with an average molecular weight of approximately 8400 Da. It functions as a wetting agent, emulsifier, and solubilizer in oral, parenteral, and topical pharmaceutical formulations. Its unique amphiphilic structure enables micelle formation to improve solubilization of poorly water-soluble APIs.
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Poloxamer 407 (Pluronic F127)
CAS: 9003-11-6
Poloxamer 407 (Pluronic F127) is a high-molecular-weight nonionic block copolymer with an average MW of approximately 12,600 Da, exhibiting thermoresponsive gelation properties—flowing as a liquid at low temperatures but forming a gel at body temperature. This unique property makes it ideal for in situ gelling formulations, controlled-release depot systems, and topical vehicles.
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Polyethylene Glycol 4000 (PEG 4000, Pharmaceutical Grade)
CAS: 25322-68-3
Pharmaceutical grade PEG 4000 is a solid-grade polyethylene glycol with an average molecular weight of 3500–4500 Da, used as a binder, plasticizer, lubricant, and solubilizer in solid and semisolid dosage forms. Its waxy consistency and water solubility make it suitable for melt granulation, tablet coating, and suppository bases. It is non-irritating and biocompatible for multiple administration routes.
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Polyethylene Glycol 6000 (PEG 6000, Pharmaceutical Grade)
CAS: 25322-68-3
Pharmaceutical grade PEG 6000 is a higher-molecular-weight solid polyethylene glycol with an average MW of 5500–7500 Da, offering increased viscosity and a higher melting point compared to PEG 4000. It is used as a suppository base, tablet binder, film coating plasticizer, and melt granulation carrier. Its water solubility and biocompatibility make it suitable for diverse oral and rectal formulations.
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Polysorbate 80 (Tween 80, Pharmaceutical Grade)
CAS: 9005-65-6
Pharmaceutical grade Polysorbate 80 (Tween 80) is a widely used nonionic surfactant and emulsifier for oral, parenteral, and topical dosage forms. It effectively solubilizes and wets hydrophobic APIs and is used to stabilize emulsions, microemulsions, and nanosuspensions. It is also employed in biopharmaceutical formulations to prevent protein aggregation.
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Polyvinyl Acetate Phthalate (PVAP)
CAS: 50865-01-5
Polyvinyl Acetate Phthalate (PVAP) is an enteric coating polymer that remains stable in acidic gastric conditions but dissolves rapidly at pH 5.0 and above, making it suitable for early intestinal drug release. It can be applied as an organic solvent solution or aqueous dispersion and exhibits excellent resistance to moisture uptake during storage.
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Povidone K30 (PVP K30)
CAS: 9003-39-8
Povidone K30 (polyvinylpyrrolidone K30) is a synthetic water-soluble polymer with a K-value of 27–33, widely used as a binder in wet granulation and as a film-forming agent in coating applications. Its excellent solubility in water and various organic solvents makes it versatile for both aqueous and solvent-based processes. Compliant with USP/NF, EP, JP, and ChP standards.
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Povidone K90 (PVP K90)
CAS: 9003-39-8
Povidone K90 is a high-molecular-weight grade of polyvinylpyrrolidone with a K-value of 85–95, providing stronger binding and higher viscosity than lower K-value grades. It is particularly suitable for formulations requiring robust granule strength, sustained-release matrices, and ophthalmic preparations. Compliant with USP/NF, EP, JP, and ChP pharmacopoeias.
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Pregelatinized Starch
CAS: 9005-25-8
Pregelatinized Starch (PCS) is a modified starch in which the native starch granules have been partially or fully disrupted by heating in the presence of water, then dried. It functions as a multifunctional excipient providing binding, disintegrating, and flow-enhancing properties, and is suitable for direct compression, wet granulation, and dry granulation processes.
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Propylene Glycol (Pharmaceutical Grade)
CAS: 57-55-6
Pharmaceutical grade Propylene Glycol (1,2-propanediol) is a versatile, generally recognized as safe (GRAS) solvent and humectant used in oral, parenteral, topical, and inhalation formulations. It effectively dissolves a wide range of poorly water-soluble APIs, acts as a plasticizer for film coatings, and serves as a preservative co-solvent in liquid formulations.
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Propylparaben (Pharmaceutical Grade)
CAS: 94-13-3
Pharmaceutical grade Propylparaben (propyl 4-hydroxybenzoate) is an antimicrobial preservative used in combination with methylparaben to provide synergistic broad-spectrum antimicrobial protection in oral, topical, and parenteral formulations. Its higher lipophilicity compared to methylparaben makes it effective against fungi and lipophilic organisms. It is effective at low concentrations (0.01–0.1%).
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Sodium Benzoate (Pharmaceutical Grade)
CAS: 532-32-1
Pharmaceutical grade Sodium Benzoate is the sodium salt of benzoic acid, used as an antimicrobial preservative in oral liquid, topical, and cosmetic formulations. It is most effective in acidic formulations (pH 2–5) where it exists predominantly as the active undissociated benzoic acid form. It is also used as a solubilizer for caffeine and as a food-grade flavoring agent.
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Sodium Hydroxide (Pharmaceutical Grade)
CAS: 1310-73-2
Pharmaceutical grade Sodium Hydroxide is a strong alkali used as a pH adjuster and alkalizing agent in oral, parenteral, topical, and ophthalmic formulations. It is employed to achieve the desired pH for optimal API stability and patient tolerability. Pharmaceutical grade material meets stringent purity requirements for heavy metals and other impurities.
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Sodium Starch Glycolate (Explotab)
CAS: 9063-38-1
Sodium Starch Glycolate is a sodium salt of carboxymethyl ether of starch, used as a superdisintegrant in tablet and capsule formulations. It absorbs water rapidly, causing significant swelling that disrupts tablet structure and enables rapid drug release. It is effective at low levels (2–8%) and is compatible with water-soluble and water-insoluble APIs.
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Sodium Stearyl Fumarate (Pruv)
CAS: 4070-80-8
Sodium Stearyl Fumarate (Pruv) is a highly effective tablet lubricant that is notably less sensitive to over-lubrication than magnesium stearate, making it ideal for moisture-sensitive and extended mixing conditions. It is particularly valuable in formulations with APIs susceptible to hydrolysis, as it does not generate stearic acid or magnesium ions.
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Sorbitol (Pharmaceutical Grade)
CAS: 50-70-4
Pharmaceutical grade Sorbitol is a polyhydric sugar alcohol used as a diluent, humectant, and sweetener in oral and topical pharmaceutical formulations. It is available in both crystalline and liquid forms and is valued for its mild sweetness, good solubility, and compatibility with various APIs. Compliant with USP/NF, EP, JP, and ChP pharmacopoeias.
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Stearic Acid (Pharmaceutical Grade)
CAS: 57-11-4
Pharmaceutical grade Stearic Acid is a saturated fatty acid used as a tablet and capsule lubricant, with slightly less sensitivity to over-lubrication than magnesium stearate. It is also used as a binder in wax matrix sustained-release tablets and as a coating agent. Available in multiple grades differing in stearic acid content to meet various pharmacopoeial specifications.
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Talc (Pharmaceutical Grade)
CAS: 14807-96-6
Pharmaceutical grade Talc is a purified, hydrated magnesium silicate used as a glidant, lubricant, and anti-tacking agent in tablet, capsule, and film coating formulations. It improves powder flowability and reduces adhesion during coating. Pharmaceutical grade talc is asbestos-free and meets stringent purity specifications for oral and topical use.
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Tartrazine (FD&C Yellow No. 5)
CAS: 1934-21-0
Tartrazine (FD&C Yellow No. 5, E102) is a water-soluble lemon-yellow azo dye used as a colorant in oral pharmaceutical formulations, food products, and cosmetics. It provides bright, stable coloration and is used at very low concentrations (0.001–0.1%) in tablets, capsules, and liquid preparations. Its use requires declaration on the label in many jurisdictions due to allergy considerations.
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Titanium Dioxide (Pharmaceutical Grade)
CAS: 13463-67-7
Pharmaceutical grade Titanium Dioxide (TiO2) is a white inorganic opacifier used in tablet film coatings, capsule shells, and topical preparations to provide opacity, whiteness, and UV protection. It is chemically inert, non-absorbable, and non-toxic when used in approved pharmaceutical applications. It can be combined with other colorants to achieve a wide range of tablet colors.
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