(click on name below)
• DCP
• EX-CEL Microcrystalline Cellulose
• Other
D C P TM Unmilled Granular
Dicalcium Phosphate Dihydrate USP / FCC
D C P is used in formulation of tablets/capsules mainly as a directly compressible filler and binder
Amtech D C P is:
· Free-flowing
· Directly Compressible
· Stable
· Dense
· Inexpensive
compatible with other commonly used Pharmaceutical Tablet/Capsule excipients such as
starches, gums, celluloses, and pvp.
Tableting Properties of D C P:
Formula: % Weight
DiCalcium Phosphate Dihydrate 97 %
Sodium Starch Glycolate 2 %
Magnesium Stearate 1 %
Tablets were made on a 16-station Stokes B2 Tablet Press using 3/8” standard concave tooling.
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DCP Unmilled DiCalcium Phosphate Dihydrate
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A - AmTech Brand |
B- Major Brand |
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Tablet Weight (mg): |
720.2 |
705.7 |
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Thickness (mm): |
5.00 |
4.999 |
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Hardness (kp): |
9.04 |
7.46 |
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Disintegration (min.): |
Less Than 1 minute |
Less Than 1 minute |
DCP SPECIFICATIONS
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Description: |
Calcium Phosphate, Dibasic, Unmilled, USP Grade for use in direct compression. White odorless powder. |
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Formula: |
CaHPO42H2O |
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M.W.: |
172.09 |
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CAS #: |
7789-77-7 |
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Chemical & Physical: |
Identification: |
Passes A & B |
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Assay (as CaHPO42H2O): |
98.0 - 105.0% |
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Loss on Ignition: |
24.5 - 26.5% |
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Acid Insolubles: |
NMT 0.2% |
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Heavy Metals: |
NMT 30 ppm |
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Fluoride: |
NMT 50 ppm |
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Chloride |
NMT 0.25% |
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Sulfate: |
NMT 0.5% |
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Arsenic: |
NMT 3 ppm |
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Carbonate: |
No effervescence |
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Barium: |
No turbidity |
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Organic Impurities |
Passes |
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Sieve Analysis: |
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Through US #40 |
NLT 95% |
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On US #40: |
NMT 5% |
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Through US #200: |
NMT 20% |
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On US #200: |
NLT 80% |
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Microbiological: |
Yeast & Mold: |
NMT 100 |
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Total Plate Count: |
NMT 1000 |
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Bulk Density: |
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Bulk: |
0.8 - 0.9 g/ml |
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Tapped: |
0.9 - 1.05 g/ml |
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The information in this website is presented for your consideration in the belief that it is accurate and reliable. However, no warranty either expressed or implied is made and no freedom from liability from patents, trademarks, or other limitations should be inferred.
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Microcrystalline Cellulose N.F.
For Direct Compression and Wet Granulation of Tablets and Capsule Products
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VERSATILE PERFORMANCE |
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§ Acts as Excellent Wet Binder § Provides Rapid Wicking Action § Permits Faster Addition of Granulation Fluid § Promotes Uniform Drug Distribution § Allows Less Screen Blockage § Speeds Drying § Promotes Dissolution |
§ Strong Dry Binder § High Dissolution Potential § More Consistent Flow § Low Tablet Friability and Tablet Disintegration § Low Lubrication Demand § Absorbent-Oleaginous Activities Become More Flowable |
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FUNCTIONAL ADVANATAGES IN WET GRANULATION: |
FUNCTIONAL ADVANATAGES IN DIRECT DIRECT COMPRESSION: |
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§ Acts as Excellent Wet Binder § Provides Rapid Wicking Action § Permits Faster Addition of Granulation Fluid § Promotes Uniform Drug Distribution § Allows Less Screen Blockage § Speeds Drying § Promotes Dissolution |
§ Strong Dry Binder § High Dissolution Potential § More Consistent Flow § Low Tablet Friability and Tablet Disintegration § Low Lubrication Demand § Absorbent-Oleaginous Activities Become More Flowable |
UPPER COMPRESSION FORCE VS. HARDNESS
EX-CEL SPECIFICATIONS
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EX-CELÒ 101 |
EX-CELÒ 102 |
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Loss on Drying |
7.0 % max. |
7.0 % max. |
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Degree of Polymerization |
LT 350 |
LT 350 |
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Bulk Density |
0.26 - 0.32 g/cm3 |
0.30-0.36 g/cm3 |
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Particle Size Distribution |
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d10: |
LT 30 mm |
LT 50 mm |
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d50: |
40-70 mm |
90-110 mm |
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d90: |
NLT 80 mm |
NLT 160 mm |
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Identification A |
Passes |
Passes |
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Identification B |
Passes |
Passes |
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Identification C |
Passes |
Passes |
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Conductivity |
75 mS max. |
75 mS max. |
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pH |
5.0 - 7.0 |
5.0 - 7.0 |
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Residue on Ignition |
0.05 % max. |
0.05 % max. |
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Water Soluble Substances |
0.24 % max. |
0.24 % max. |
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Ether Soluble Substances |
0.05 % max. |
0.05 % max. |
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Heavy Metals |
LT 10 ppm |
LT 10 ppm |
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Organic Volatile Impurities |
Meets Requirements |
Meets Requirements |
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Total aerobic count |
less than 100/g |
less than 100/g |
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Yeasts and Molds |
less than 50/g |
less than 50/g |
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E. coli |
Absent |
Absent |
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Staphylococcus aureus |
Absent |
Absent |
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Pseudomonas aeruginosa |
Absent |
Absent |
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Salmonella |
Absent |
Absent |
The information in this website is presented for your consideration in the belief that it is accurate and reliable. However, no warranty either expressed or implied is made and no freedom from liability from patents, trademarks, or other limitations should be inferred.
For Other Excipients, Products / Svcs or Links Click Here
Omnilube V
Magnesium Stearate NF
Used mainly as a lubricant for manufacturing tablets & capsules.
Derived from vegetable source.
Comparable to competitive Magnesium Stearate in tableting characteristics.
Formula: Microcrystalline cellulose – 99.5%
Magnesium stearate – 0.5%
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Avg. Tablet Weight |
Avg. Hardness |
Weight Range |
Hardness Range |
Tablet Disintegration Times |
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Omnilube V
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520 mg |
15.4 kP |
513-528 mg |
12.9-17.4 kP |
3-4 min. |
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Major Brand Magnesium Stearate |
518 mg |
16.3 kP |
511-533 mg |
13.8-18.4 kP |
3-4 min. |
Table No. 1
The values for tablet weights, hardness, and disintegration times are close to the leading competition
OMNILUBE SPECIFICATIONS
| Description: | Omnilube V, Magnesium Stearate NF is a fine white powder used as a lubricant in tablet compacting | |
| Chemical & Physical: |
MgO |
6.8% to 8.3% |
| Loss on Drying | NMT 4.0% | |
| Identification | Passes | |
| Lead (as Pb) | NMT 0.001% | |
| Organic Volatile Impurities | Passes | |
| Microbiological: | Total Bacteria Count | NMT 1000/g |
| E. coli | Negative | |
| Salmonella | Negative | |
Omnilube V is comparable and equivalent to major competitive products in the U.S.A.
1. Compression v. ejection forces at 5 minutes and 15 minutes mix. (Fig. 1 and 2 below)
2. Hardness v. the compression forces. (Fig. 3 below)
3. Adhesion properties. (Fig. 4 below)
There are no significant differences in any of the properties evaluated
Fig. 1
Fig.2
Fig.3
Fig.4
The information in this website is presented for your consideration in the belief that it is accurate and reliable. However, no warranty either expressed or implied is made and no freedom from liability from patents, trademarks, or other limitations should be inferred.
For Other Excipients, Products / Svcs or Links Click Here
Information on the following excipients is not presented here, but is available by contact us:
PVP
Stearic Acid
Ca Sulfate
& Others
For Other Excipients, Click Here
For Other Products / Services, or Links Click Here
PO Box 33, Piscataway, NJ 08855
Tel: 732.365.0550 Fax: 732.885.1235
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Email: Amtechresources@yahoo.com |