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The product conforms
to the standards of USP / NF, BP / EP, JP
US-DMF
No. 6821
TYPES
& ADDITIONAL INHOUSE SPECIFICATIONS OFFERED
|
TYPE
|
TYPICAL
Particle size
|
PARTICLE
Moisture Distribution
|
BULKDENSITY
(Max) %
|
g/ml
|
| |
|
|
|
|
|
101
|
50
(microns)
|
+60
mesh NMT 1.0 %
+200 mesh NMT 30.0%
|
7.0
%
|
0.26
- 0.31
|
|
102
|
90
(microns)
|
+60
mesh NMT 8.0 %
+200 mesh NLT 45.0%
|
7.0
%
|
0.28
- 0.33
|
|
103
|
50
(microns)
|
+60
mesh NMT 1.0 %
+200 mesh NMT 30.0%
|
3.0
%
|
0.26
- 0.31
|
|
105
|
20
(microns)
|
+60
mesh NMT 0.1 %
+400 mesh NMT 1.0%
|
5.0
%
|
0.20
- 0.30
|
|
112
|
90
(microns)
|
+60
mesh NMT 8.0 %
+200 mesh NLT 45.0%
|
1.5
%
|
0.28
- 0.34
|
|
113
|
50
(microns)
|
+60
mesh NMT 1.0 %
+200 mesh NMT 30.0%
|
2.0
%
|
0.27
- 0.34
|
|
200
|
180
(microns)
|
+60
mesh NLT 10.0 %
+100 mesh NLT 50.0%
|
5.0
%
|
0.29
- 0.36
|
|
301
|
50
(microns)
|
+60
mesh NMT 1.0 %
+200 mesh NMT 30.0%
|
5.0
%
|
0.34
- 0.45
|
|
302
|
90
(microns)
|
+60
mesh NMT 8.0 %
+200 mesh NLT 45.0%
|
5.0
%
|
0.35
- 0.45
|
| |
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PERFORMANCE
OF ALFACEL-PH IN TABLETING
|
|
ADVANTAGES
|
|
FUNCTIONS
|
| |
|
|
| Chemical
Purity |
|
Non
reactive organic ingredients, extremely low level of
inorganic & organic contaminants. |
| |
|
|
| Binder |
|
High
hardness level, low friability, excellent compression. |
| |
|
|
| Disintegrant |
|
Promotes
rapid disintegration |
| |
|
|
| Co-lubricant |
|
Requires
less lubricant than other typical binders. |
| |
|
|
The amount
of Alfacel-P used in the direct compression tableting depends on the flow
& compression characteristics of the formulation's other ingredients.
Normally about 20 percent of the formulation is Alfacel-P, but the typical
range is from 10 to 50 percent.
When added to
granulations, generally 15 percent is used, it is often added to both
the wet mass and the dried granulation before compression. As with direct
compression, the use level ranges widely from under 10 percent to much
higher levels, depending on the application.
ENCAPSULATION
WITH ALFACEL MCC
The newer technology for manufacturing capsule dosage forms has created
another area for the application of ALAFACEL. The properties imparted
to a formulation by ALFACEL are ideal for processing on high speed, gravity
fill equipment. As a binder, ALFACEL is especially useful in formulations
which are compressed before insertion into the hard gelatin capsule.
DISCLAIMER
PATENTS
Reliance Cellulose Products Limited does not warrant against infringement
of patents of third party by reason of any uses made of the product in
combination with other material or in the operation of any process, and
purchasers assume all risks of patent infringement by reason of any such
uses, combination, or operation.
WARRANTY
Because of the numerous factors affecting results, Reliance Cellulose
Products ingredients are sold on the understanding that purchasers will
make their own tests to determine suitability of these products for their
particular purpose. The several uses suggested by Reliance Cellulose Products
limited are presented only to assist our customers in exploring possible
applications. All information and data presented are believed to be accurate
and reliable, but are presented without the assumption of any liability
by Reliance Cellulose Products Limited. The information contained in this
pamphlet is intended to be general in nature.
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