Medical-use Ethyl Cellulose
Brief
Property
white, tasteless, odorless, non-toxic granule or powdery, it is stable in light and heat Softening temp. 135- 155°C, Melting point165- 185°C. Ethyl cellulose is soluble in common solvent, It is compatible with varieties of resins and plasticizer. The film and plastic articles made form ethyl cellulose have good mechanical strength and toughness at higher or lower temperature.
Technical requirements
1. Appearance
white to yellowish tasteless, odorless, non-toxic granule or powder.
2. Technical index
Table 1
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Items
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Index
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Aspect and Properties
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White or off-white powder or granule
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Freely soluble in alcohol, methanol, toluene, chloroform, and ethyl
acetate. Insoluble in water, glycerin, and propylene glycol.
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Identification
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Infrared absorption spectrum should be consistent with the reference substance
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Viscosity (5%, 1:4 ethanol : toluene, 25C, mPas)
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Meet the requirement of Table 2
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Ethoxyl content, %
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K-type
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N-type
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T-type
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44.0 - 47.4
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47.5 - 49.5
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49.6 - 51.0
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Ignited residue (%)
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NMT 0.4
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Loss on drying (%):
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NMT 3.0
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Heavy metals,%
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NMT 0.0010
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Arsenic salt, %
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NMT 0.0003
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Acetaldehyde, %
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NMT 0.01
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Chloride, %
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NMT 0. 1
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Solubility, %
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NLT 100
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Acidity or alkalinity
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Pass
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3. Viscosity
Table 2
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Spec.
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viscosity range mPa•s
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Spec.
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viscosity range mPa•s
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4
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3.0-5.6
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50
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40-60
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7
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5.6-8.4
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70
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56-84
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10
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8- 12
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100
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80- 120
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20
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16-24
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200
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160-240
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35
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28-42
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300
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240-360
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Note 1: Viscosity specifications can be negotiated within the limits specified in the pharmacopoeia.
4. Residual Solvent
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Item
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Specification
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Toluene , %
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NMT 0.089
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Ethanol , %
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NMT 0.5
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Diethyl ether , %
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NMT 0.5
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5. Microbial Limit
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Item
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Specification
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Total amount of Aerobicbacteria, CFU/g
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NMT 103
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Total amount of Mold and Yeast, CFU/g
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NMT 102
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Staphylococcus Aureus, CFU/g
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Pass
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Pseudomonas Aeruginosa, CFU/g
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Pass
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Escherichia Coli, CFU/g
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Pass
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Usage
Mainly used as tablet adhesive and in coating, insulation material, special coating layer, alloy adhesive, filler, slow-releasing agent and material of micro-encapsulation.
Packing
In paper bag or paper drum, fiber drumlined with PE bag, net weight 10kg / 20kg/25kg.
Storage
Closed tight, stored in dry place.
