DATASHEET #: TDS-01
Hydroxypropyl Cellulose
USP/NF, EP, JP
TECHNICAL DATA SHEET
Availability
Nisso HPC Grades & Applications
NISSO HPC
SSL
SL
L
M
H
Viscosity mPa•s @ 20˚C/2%aq
2.0 – 2.9
3.0 – 5.9
6.0 – 10.0
150 – 400
1,000 – 4,000
Molecular Weight/GPC method
~40,000~
~100,000~
~140,000~
~620,000~
~910,000~
Regular Powder (40 mesh)
Fine Powder (100 mesh)
Super Fine Powder (330 mesh)
High Shear Mixer
Granulation
Fluidized Bed
Granulation
Application
Dry Granulation
Direct Compression
Orally Disintegrating
Tablet
Drug Layering on
Multi-Unit Particle
Solubility Enhancement
Film Forming
Sustained Release
Matrix
= Dry/Powder Use
= Wet/Solution Use
Powder Types, Uses and Advantages
Regular 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. As a film coating agent, HPC improves film flexibility, elongation,
and adhesion to the tablet.
Fine 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 polymers.
Super Fine Powder: SFP grade offers the highest level of formability. Excellent tablet properties can be obtained at low use level
in direct compression applications. 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 disintegrator.
Nisso HPC Solubility
Soluble
Water, methyl alcohol, ethyl alcohol, isopropyl alcohol, pyridine, cyclohexanone, cellosolve, acetic acid
Hazy
Acetone, tertiary butanol , dioxane, cyclohexanol, lactic acid, methyl ethyl ketone
Insoluble
Aliphatic hydrocarbons, benzene, xylene, glycerin, toluene, gasoline
Nisso HPC Viscosity Change by Temperature, Concentration
Viscosity change vs. concentration, aqueous solution
100,000
SL
M
SSL
100,000
10,000
L
Viscosity (mPa•s)
Viscosity (mPa•s)
10,000
H
Viscosity change vs. concentration, ethanol solution
1000
100
10
H
SL
M
SSL
L
1000
100
10
1
1
1
2
3
4
5
6
7
8
9
10
1
2
3
4
Concentration (%)
5
6
7
8
9
10
Concentration (%)
Viscosity change vs. temperature, aqueous solution
Viscosity change vs. temperature, ethanol solution
1000
1000
Viscosity (mPa•s)
Viscosity (mPa•s)
HPC-H
HPC-M
100
HPC-L & SL
10
1
HPC-L
HPC-SL
10
1
1
10
20
30
Temperature (˚C)
Nisso HPC
HPC-M
100
40
50
60
1
10
20
30
40
50
60
Temperature (˚C)
2
Fine Powder,
Super Fine Powder
Regular Powder
Nisso HPC Powder Characteristics
HPC-SSL
HPC-SL
HPC-L
HPC-M
HPC-H
Bulk density loose
(g/cc)
0.38
0.38
0.40
0.44
0.42
Bulk density tapped
(g/cc)
0.55
0.50
0.52
0.52
0.50
Compressibility
(%)
32
24
22
16
17
Angle of repose
(Degree)
46
43
45
43
44
Particle size (D10)
(µm)
30
65
75
80
85
Particle size (D50)
(µm)
85
155
160
185
185
Particle size (D90)
(µm)
185
275
355
355
365
HPC-SSL-SFP
HPC-SL-FP
HPC-L-FP
HPC-M-FP
HPC-H-FP
Bulk density loose
(g/cc)
0.18
0.31
0.33
0.38
0.36
Bulk density tapped
(g/cc)
0.33
0.47
0.46
0.49
0.49
Compressibility
(%)
46
33
28
23
25
Angle of repose
(Degree)
53
47
42
44
43
Particle size (D10)
(µm)
8
35
40
50
50
Particle size (D50)
(µm)
20
85
95
105
110
Particle size (D90)
(µm)
50
165
185
190
200
Nisso HPC Particle Shape
HPC-L Fine Powder
Roundish particle
HPC-SSL Super Fine Powder
shape gives
better flowability.
Nisso HPC has
no added flow
agents.
Moisture Uptake
Softening Temperature
Moisture uptake at 50% /80% relative humidity
18
Softening temperature
(° C)
16
80% RH
Moisture content (%)
14
12
10
HPC-L, SL
HPC-M
8
50% RH
6
4
1st
transition
2nd
transition
HPC-H
73
164
HPC-M
68
178
HPC-L
60
185
HPC-SL
68
192
HPC-SSL
75
183
2
0
0
1
2
3
4
5
6
Days elapsed (days)
Nisso HPC
3
Additional Information
Chemical Structure,
CAS No.
Hydroxypropyl Cellulose
(cellulose, 2-hydroxypropyl ether)
H
O
CH2OR
OR
OR H
O
H
H
H
O
H
OR
H
H
OR
H
O
CH2OR
•R : -H
or
CH3
CH2 CH 0
H
m
CAS No. 9004-64-2
Safety
Compendial Satus
Additives
Hazardous Identification, First Aid Measures and Fire Fighting Measures: See MSDS
Accidental Release Measures: Sweep up, place in containers and hold for waste disposal
Stability/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 agents
USP/NF, EP, JP compliant; Food use approved 21 CFR 172.870, E463
Nisso HPC contains no silica or other additives
Expiration
Expiration date is five (5) years from date of manufacture
Packaging
10 kg box, double lined PE bag
Site of Manufacture
Nippon Soda Co., Ltd.
Nihongi Plant
950 Fujisawa, Joetsu City
Niigata Prefecture, JAPAN
Notice
The 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 specifications.
www.nissoexcipients.com
Head Office
U.S./Canada
Europe
Nippon Soda Co., Ltd
Nisso America Inc.
Nisso Chemical Europe, GmbH
2-1 2-Chome, Ohtemachi
Wall Street Plaza
Berliner Allee 42, 40212
Chiyoda-ku, Tokyo 100-8165 Japan
88 Pine Street, 14th Floor
Duesseldorf, Germany
(T) 81-3-3245-6351
New York, NY 10005
(T) +49-(0)-211-1306686-0
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(T) 212-490-0350
(F) +49-(0)-211-328231
info@nippon-soda.co.jp
info@nissoamerica.com
info@nisso-chem.de
TDS-01
Version 1.6
© Copyright 2013 Nisso HPC