NATIONAL 78-1551 Specialty Starch - Anshul Life Sciences

NATIONAL 78-1551 Specialty Starch
Reduces processing time,
provides strong binding/adhesion

NATIONAL 78-1551
Pregelatinized corn starch as binder for solid dosage forms
NATIONAL 78-1551, a specially processed pregelatinized
corn starch, swells in cold water and develops
strong binding or adhesive properties. It is prepared
under carefully controlled cGMP conditions to
optimize its performance in solid dosage forms. In
addition, NATIONAL 78-1551 is whiter in color and
has cleaner taste than conventional starches.
Product Profile
Wet Granulation Binder
NATIONAL 78-1551 provides excellent binding
properties in wet granulation applications.
NATIONAL 78-1551 swells in cold water and develops
strong binding or adhesive properties, thus eliminating
the need for preparing starch pastes. In this
way, NATIONAL 78-1551 reduces processing costs
by eliminating time and expense of preparing traditional
binder solutions. When NATIONAL 78-1551
is used as a wet granulation binder, the optimum
concentration depends on the level of solvent, shear
conditions of the granulator, and the temperature of
the granulation. Furthermore, the binding properties
of NATIONAL 78-1551 are retained after conventional,
fluid-bed, and high-shear granulations.
Enhanced Tablet Properties
Improves Compressibility
Reduces Disintegration Time
Binder Selection Process
The optimum performance of NATIONAL 78-1551
depends on various factors including the physicochemical
properties of the drug, type of filler and the
process used to make granules and tablet. In a given
formulation, tablet performance is determined by
the processing conditions.
PROCESS - Wet Granulation
A
B
High/Low shear
or fluid-bed process
Binder Addition (powder)
Granulate with
water/moisture
Drying (tray/fluid bed)
Binder Addition (solution/paste)
High/Low shear
Screening

Product Specifications
Physical and Chemical Characteristics
COLOR
White to off-white
FORM
Fine powder
MOISTURE
14% maximum
pH 4.5 - 7.0
RESIDUE ON IGNITION 0.5% maximum
OXIDIZING
Complies to
SUBSTANCES
NF standards
ORGANIC VOLATILE Complies to
IMPURITIES
NF standards
SULFUR DIOXIDE 0.001% maximum
Microbiological Specifications
E. Coli Negative
Salmonella
Negative
S. Aureus Negative
Klebsiella
Negative
P. Aeruginosa Negative
Label Declaration
Pregelatinized Corn Starch NF
Who we are
National Starch and Chemical Company is an
experienced participant in the world of pharmaceuticals,
health and nutrition. For decades, our starches
have been key ingredients, as binders, disintegrants,
encapsulants, and viscosifying agents, in medications
and vitamins. We're an experienced global supplier you
can count on – one with world class manufacturing
facilities that will continue to supply consistent products
year after year.
We operate complete analytical and pilot plant facilities
around the world, including a state-of-the-art solid oral
dosage laboratory at our research headquarters in
Bridgewater, New Jersey, to help you select, test, and
scale up your formulation. As a global leader in specialty
starch research and manufacturing, we maintain
manufacturing, technical service, and sales centers
in key business centers on six continents. We are ready
to service your account in any part of the
world. For more information, visit our web site at
www.nationalstarch.com or www.excipients.com, or
contact your local National Starch and Chemical
representative.
Chemical Description
CAS Registry Number 9005-25-8
CAS Registry Name Starch
Storage and Handling
NATIONAL 78-1551 is packaged in four-ply, kraft
paper bags and fiber drums. It is recommended that
NATIONAL 78-1551 be stored in a clean, dry area at
ambient temperature and away from aromatic
material. The shelf life for NATIONAL 78-1551 is
24 months from the date of receipt

North America – Bridgewater, NJ
+1 908 685-5303
Fax +1 908-685-5489
Regional Technical Centers
Europe – Hamburg, Germany
+49 (0) 40-23915-0
Fax +49 (0) 40-23915-170
Asia/Pacific – Singapore
+65 872-5335
Fax +65 872-5988
National Starch and Chemical Company, 10 Finderne Avenue, Bridgewater, NJ 08807-3300 U.S.A.
National Starch and Chemical Information Center Tel: 1-800-797-4992 Fax: 1-609-409-5699 Internet: www.excipients.com
The information given and the recommendations made herein are based on our research and are believed to be accurate but no guarantee of their accuracy is made. In every case we urge and recommend that purchasers before
using any product in full scale production make their own tests to determine to their own satisfaction whether the product is of acceptable quality and is suitable for their particular purposes under their own operating conditions.
No representative of ours has any authority to waive or change the foregoing provisions but, subject to such provisions, our engineers are available to assist purchasers in adapting our products to their needs and to the circumstances
prevailing in their business. Nothing contained herein shall be construed to imply the nonexistence of any relevant patents or to constitute a permission, inducement or recommendation to practice any invention covered by any
patent, without the authority from the owner of this patent. We also expect purchasers to use our products in accordance with the guiding principles of the Chemical Manufacturers Association’s Responsible Care® program.
5201-00-0610-2M
© 2000 National Starch and Chemical Company