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Glyceryl behenate CAS:77538-19-3 Product Introduction
DEFINITION
Glycerol dibehenate EP10.0 / Glyceryl dibehenate NF38 / Glyceryl behenate CP2020 /Eicosadioate
PACKAGING
1kg/bag, 5kg/carton, 20kg/drum
Bag in cardboard drum 20 kg (polyethylene bag).
Sample available upon request.
APPEARANCE:
White or off-white powder or hard wax block; it has a slight odor. Soluble in chloroform and almost insoluble in water or ethanol.
ORIGIN OF THE RAW MATERIALS
The product is manufactured from raw materials of strictly vegetable origin.
DESCRIPTION
– CAS: 77538-19-3 (or 91052-55-0) (or 30233-64-8) (or 94201-62-4)
– EINECS: 278-717-5 (or 293-216-1) (or 250-097-0) (or 303-650-6)
ADDITIONAL TESTS
Average particle size: D97=187µm
SOLUBILITIES AT 20°C(Eur. Ph.)
– Ethanol 96°: Partly soluble in hot ethanol 96°
– Chloroform, Methylene chloride: Soluble under heating conditions
– n-Hexane: Insoluble
– Water: Insoluble
– Mineral oils: Insoluble
QUALITY STANDARD: ChP2020; USP43-NF38; EP9.0; GB1886.65-2015
| TEST | SPECIFICATION | ||
| Melting Point | 65～77℃ | ||
| Acid Value | NMT 4 mg KOH/g | ||
| Saponification Value | 145-165 mg KOH/g | ||
| Iodine Value | NMT 3 gl2/100g | ||
| Peroxide Value | NMT 6 meqO2/kg | ||
| Free Glycerin | NMT 1.0% | ||
| Water Content | NMT 1.0% | ||
| Residue On Ignition | NMT 0.1% | ||
| Total Ashes Content | NMT 0.1% | ||
| Nickel Content | NMT 1 Ppm | ||
| Heavy Metals(Pb) | NMT 10 ppm | ||
| Arsenic Content | NMT 2 ppm(expressed in AS2O3) | ||
| Palmitic Acid(C16) | NMT 3.0% | ||
| Stearic Acid(C18) | NMT 5.0% | ||
| Arachidic Acid(C20) | NMT 10.0% | ||
| Behenic Acid(C22) | NLT 83.0% | ||
| Erucic Acid(C22:1) | NMT 3.0% | ||
| Lignoceric Acid(C24:0) | NMT 3.0% | ||
| Monoglycerides | 15.0-23.0% | ||
| Diglycerides | 40.0-60.0% | ||
| Triglycerides | 21.0-35.0% | ||
| Residual Solvents (EP/NF) | Production without solvents | ||
FIELD OF USE
This product is a pharmaceutical ingredient. It is recommended for use in pharmaceutical
formulations administered by oral, topical and/or rectal/vaginal routes.
USES
Dermal drug delivery: consistency agent (thickener) for silicone gelling agents and emulsions
Oral drug delivery: modified-release agent.
Oral drug delivery: lubricant for tablets and capsules.
Oral drug delivery: excipient for direct compression.
Taste masking agent
Emulsifier in food.
Daily chemical products such as facial cleanser, toner, shampoo, toothpaste
| Application | Dosage/ % | Examples | ||
| Sustained release skeleton material |
>10.0 | Loratadine and Pseudoephedrine Sulfate Sustained Release Tablets | ||
| Fat-soluble coating material | >10.0 | |||
| Lubricants for tablets, etc | 1.0-3.0 | Captopril Tablets | ||
| Taste-masking agent | Amoxicillin Dry Suspension | |||
| Adhesives for tablets, etc | 1.0-3.0 | |||
| Thickeners for gels, emulsions, etc | 1.0-15.0 | |||
Glyceryl behenate BENEFITS:
As a sustained release skeleton material:
Suitable for a wide range of tabletting process: direct tabletting, wet granulation, dry granulation and hot melt granulation; PH-independent drug release; Burst-free drug release related to ethanol; Drug release through diffusion mechanism to avoid burst effect; Without digestion and high physiological tolerance.
As a lubricant:
No effect on disintegration time and drug release; Improve compressibility in tablet and capsule production; Do not interfere with drug testing; Do not reduce tablet hardness; Acid drugs can use it.
SAFETY: Generally considered non-toxic and non-irritating.
STORAGE RECOMMENDATIONS
Store the product in its original packaging sealed tightly, protected from light and moisture. Store at a temperature inferior or equal to 30 °C. During storage at high temperature (> 35°C), there is a risk of powder caking. Product has a shelf-life of 2 years under the recommended storage conditions and should not be used after its expiry date.
SHELF LIFE: 2 years.
Related Products——Pharmaceutical excipients
| Product | CAS |
| CROSCARMELLOSE SODIUM | 74811-65-7 |
| Methylparaben | 99-76-3 |
| Triethanolamine | 102-71-6 |
| Butylated hydroxyanisole | 25013-16-5 |
| 2-Phenoxyethanol | 122-99-6 |
| Glyceryl Monolinoleate | 26545-74-4 |
| OLEIC ACID OLEYL ESTER | 3687-45-4 |
| Diethylenetriaminepentaacetic acid | 67-43-6 |
| Butylated Hydroxytoluene | 128-37-0 |
| Polyvinylpyrrolidone | 9003-39-8 |
| 3-Hydroxy-2-methyl-4H-pyran-4-one | 118-71-8 |
| Ethyl acetate | 141-78-6 |
| Hydrogenated castor oil | 8001-78-3 |
| Triethyl citrate | 77-93-0 |
| Diethyl phthalate | 84-66-2 |
| Methyl salicylate | 119-36-8 |
| Phenethyl alcohol | 60-12-8 |
| Benzyl alcohol | 100-51-6 |
| m-Cresol | 108-39-4 |
| ALUMINUM MONOSTEARATE | 7047-84-9 |
| 1,3-Butanediol | 107-88-0 |
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