NISSO HPC SSL SL L M H

1 TECHNICAL DATA SHEETDATASHEET #:TDS-01 NISSO HPC Grades & Applications NISSO HPCSSLSLLMHV iscosity mPa s @ 20 C/2% 4001,000 4,000 Molecular Weight/GPC method~40,000~~100,000~~140,000~~620,000 ~~910,000~AvailabilityRegular Powder (40 mesh) Fine Powder (100 mesh) Super Fine Powder (330 mesh) ApplicationHigh Shear Mixer GranulationFluidized Bed GranulationDry GranulationDirect CompressionOrally Disintegrating TabletDrug Layering on Multi-Unit ParticleSolubility EnhancementFilm FormingSustained Release MatrixHydroxypropyl CelluloseUSP/NF, EP, JP= Dry/Powder Use= Wet/Solution UseNisso HPC SolubilityNisso HPC2 SolubleWater, methyl alcohol, ethyl alcohol, isopropyl alcohol, pyridine, cyclohexanone, cellosolve, acetic acidHazyAcetone, tertiary butanol , dioxane, cyclohexanol, lactic acid, methyl ethyl ketoneInsolubleAliphatic hydrocarbons, benzene, xylene, glycerin, toluene, gasolineViscosity change vs.

2 Temperature, aqueous solutionViscosity change vs. temperature, ethanol solutionViscosity change vs. concentration, aqueous solutionViscosity change vs. concentration, ethanol solutionNisso HPC Viscosity Change by Temperature, Concentration123456101001000 Viscosity (mPa s)Concentration (%)100,00010,000110897 HMLSLSSL123456101001000 Viscosity (mPa s)Concentration (%)100,00010,000110897 HMLSLSSL11020304010100 Viscosity (mPa s)Temperature ( C)100016050 HPC-HHPC-MHPC-L & SL11020304010100 Viscosity (mPa s)Temperature ( C)100016050 HPC-MHPC-LHPC-SLPowder Types, Uses and AdvantagesRegular Powder: Regular Powder type HPC is mainly used in solution form. As a binder for wet granulation applications, low viscosity grades of HPC give an excellent balance of properties to oral solid dosage tablets by imparting superior strength and elegance without compromise of the disintegration profile.

3 As a film coating agent, HPC improves film flexibility, elongation, and adhesion to the Powder: Fine Powder type HPC has better formability than Regular Powder type and is mainly used in dry powder form. Having good wettability, lower viscosity grades are used as a dry-mix binder in high shear mixer formulations. Higher viscosity grades of HPC are applicable to controlled release matrix tablet formulations by direct compression application and give better release profiles compared to other common CR Fine Powder: SFP grade offers the highest level of formability. Excellent tablet properties can be obtained at low use level in direct compression applications.

4 SFP is applicable to poorly compressible drug and high drug load formulations. Additionally, excellent tablet properties can be achieved in orally disintegration tablet (ODT) formulations by direct compression method when SFP grade is used in combination with a super HPC3 Moisture Uptake01234628410121416 Moisture content (%)Days elapsed (days)18065 HPC-L, SLHPC-M80% RH50% RHMoisture uptake at 50% /80% relative humidityNisso HPC Powder Characteristics HPC-SSLHPC-SLHPC-LHPC-MHPC-HRegular PowderBulk density loose (g/cc) density tapped(g/cc) (%)3224221617 Angle of repose(Degree)4643454344 Particle size (D10)( m) 30 65 75 8085 Particle size (D50)( m)85155160185185 Particle size (D90)( m)

5 185275355355365 HPC-SSL-SFPHPC-SL-FPHPC-L-FPHPC-M-FPHPC- H-FPFine Powder, Super Fine Powder Bulk density loose (g/cc) density tapped(g/cc) (%)4633282325 Angle of repose(Degree)5347424443 Particle size (D10)( m) 8 35 4050 50 Particle size (D50)( m)208595105110 Particle size (D90)( m)50165185190200 Softening TemperatureSoftening temperature ( C)1st transition2nd transitionHPC-H73164 HPC-M68178 HPC-L60185 HPC-SL68192 HPC-SSL75183 NISSO HPC Particle Shape HPC-SSL Super Fine PowderHPC-L Fine PowderRoundish particle shape gives better flowability. NISSO HPC has no added flow America Street Plaza88 Pine Street, 14th FloorNew York, NY 10005(T) Chemical Europe, GmbHBerliner Allee 42, 40212 Duesseldorf, Germany(T) +49-(0)-211-1306686-0(F) OfficeNippon Soda Co.

6 , Ltd2-1 2-Chome, OhtemachiChiyoda-ku, Tokyo 100-8165 Japan(T) 81-3-3245-6351(F) Copyright 2013 NISSO HPCN oticeThe information described in this sheet is believed to be accurate and is presented in good faith with no guarantee or obligation as to accuracy and no assumption of liability. Users should make their own tests to determine the suitability of products for their own particular use. NISSO makes no warranty of any kind, express or implied, including those of merchantability and fitness for particular purpose other than the material conforms to its applicable current standard Additional InformationChemical Structure, CAS Cellulose(cellulose, 2-hydroxypropyl ether)HORCH2 ORCH2 OROOOOHHORORHHHHHH R : -HCH3 HmCH2CH0orCAS No.

7 9004-64-2 SafetyHazardous Identification, First Aid Measures and Fire Fighting Measures: See MSDSA ccidental Release Measures: Sweep up, place in containers and hold for waste disposalStability/Reactivity:- Flash Point: Not Applicable- Powder Explosiveness: 65g/m3 (regular powder); 50g/m3 (fine powder, super fine powder) (lower limit)- HPC is chemically stable but must be kept away from strong oxidixing agentsCompendial SatusUSP/NF, EP, JP compliant; Food use approved 21 CFR , E463 AdditivesNisso HPC contains no silica or other additivesExpirationExpiration date is five (5) years from date of manufacturePackaging10 kg box, double lined PE bagSite of ManufactureNippon Soda Co.

8 , Ltd. Nihongi Plant 950 Fujisawa, Joetsu City Niigata Prefecture, JAPAN