Professional Documents
Culture Documents
Product Guide
Global Leader in Immediate Relief
Antacid Actives
Peptic ulcers are open sores that develop on the inside lining
of the stomach, upper small intestine or esophagus. The most
common symptoms of a peptic ulcer are heartburn and pain.
567
1
4
2
3
Al(OH)3 + 3HCl
AlCl3 + 3H2O
Mg(OH)2 + 2HCl
MgCl2 + 2H2O
CaCO3 + 2HCl
4
3
Same neutralization
capacities, but at
different speeds.
Lower esophagus
sphincter closed
20
30
40
50
60
Time (Mins)
Aluminum Compounds
Aluminum Hydroxide
Aluminum hydroxide is a typical antacid active. It can be
used alone or in combination with magnesium hydroxide to
obtain the desired acid neutralizing capacity (ANC). Aluminum
hydroxide as an antacid is not exactly an aluminum
hydroxide, (Al(OH)3). Aluminum hydroxide gels are amorphous
in nature and contain carbonate in the gel structure. The
presence of carbonate increases the reactivity of the
aluminum, allowing for its acid neutralizing capacity, making
it a more effective antacid.
Our line of aluminum hydroxide gels provides options to our
customers based on various assays and viscosities to meet
their suspension formulation needs.
Whether produced by a wet granulation or direct compression
process, we offer a portfolio of aluminum powders varying
in density and particle size distribution to meet your antacid
tablet requirements.
Our line of aluminum hydroxide gels and powders is available
worldwide and provides the consistent quality required for
pharmaceutical use. The aluminum assay for all products is
not less than 76.5% on an Al(OH)3 basis or not less than 50%
on an Al2O3 basis.
Aluminum Phosphate
In gel form, aluminum phosphate (AlPO4) functions by
coating the stomach wall. It does not neutralize stomach
acids. Aluminum phosphate absorbs gall salts and stomach
gas. Since the product does not chelate alimentary phosphate,
it does not deplete phosphorus from the stomach.
Boehmite
Boehmite is a crystalline form of aluminum hydroxide. Unlike
the amorphous form of aluminum hydroxide gel, Boehmite
does not dissolve in hydrochloric acid (HCl). Boehmite
protects the stomach wall by absorbing stomach acid and
creating a high viscosity gel. It has low aluminum solubility.
Boehmite antacid active is considered an aluminum hydroxide,
but is not chemically Al(OH)3. It is an aluminum oxyhydroxide:
AlO(OH), xH20. Composed of fibrous primary particles of a few
nanometers, Pseudo-Boehmite has adsorption properties
and a large surface area.
Magnesium Compounds
Carbonated Compounds
Magnesium Hydroxide
Like aluminum hydroxide, magnesium hydroxide is also a
typical antacid active; both are often combined, offering
a good neutralizing and pH buffering effect and compensating
their side effects. It is also used as a laxative active
(Milk Of Magnesia).
Calcium Carbonate
SPI Pharma manufactures directly compressible (DC) calcium
carbonate products for swallow and chewable tablets that
have high functionality and create a superior mouthfeel.
Aluminum/Magnesium Compounds
Aluminum Hydroxide Magnesium Carbonate
Aluminum hydroxide magnesium carbonate (AHMC),
Al(OH)3-2x(CO3)x / MgCO3, is a co-processed active ingredient
combining aluminum hydroxide and magnesium carbonate.
Our AHMC 0611 grade is specifically designed for rehydration
from the powdered form to a smooth, viscous, non-separating
suspension.
Preformulated Combinations
CoDried Powders
DC CoDried powders are preformulated products for a
more simple, quick and cost effective manufacturing process
of immediate relief antacid tablets. An improved, smooth
mouthfeel is created by porous, spherical particles with
uniform size distribution. This delivers a uniform and
homogenous dosage. The process is very consistent because
it utilizes CoDried technology, creating the same composition
from one granule to another.
CoBlend Suspensions
CoBlend is a customized preformulated product designed to
simplify the manufacturing process, improve taste and reduce
cost in the production of immediate relief antacid suspensions.
An improved, smooth mouthfeel is created by blending the
actives with sorbitol.
You can choose between our two grades, 0600 and 0652,
which vary in assay ratio between aluminum hydroxide and
magnesium carbonate to meet your needs for antacid tablets.
SPI Pharma can customize this ratio and particle size.
Magaldrate
Magaldrate, Al5Mg10(OH)31(SO4)2,xH20, is a basic aluminum
and magnesium compound possessing a layer structure
connected by water and sulfate bridges. It is crystalline by
nature. This unique crystal lattice structure results in the high
reactivity for magaldrate. The antacid effectiveness of
magaldrate can be used to treat peptic ulcers because it
neutralizes gastric acid very quickly while buffering the pH
(keeping it between 5-6), even in the presence of proteins and
pepsin. Magaldrate can also absorb large quantities of bile
acids which prevent these acids from attacking the mucous
membranes.
Magaldrate is a highly reactive antacid designed for the
formulation of suspensions and tablets. The gel is available as
10 or 20% suspension. We offer a powder form as well.
Table Of Contents
Antacid Comparison Chart
10
12
15
18
19
21
Laxative Products
29
30
31
33
47
Aluminum
Hydroxide Gels
& Powders
Description
Action
Neutralizing effect
Protective effect
Magnesium
Hydroxide Gels
& Powders
Calcium
Carbonate
Powders
Magaldrate
Gels &
Powders
Aluminum
Phosphate
Gel
Boehmite Gel
Suspensions
From Powders
(Use of Suspending Agents
Recommended)
Aluminum
Hydroxide
Powders
Magnesium
Hydroxide
Powders
0200 P.10
0325 P.10
5100 P.10
5200* P.10
5300 P.10
Aluminum
Hydroxide
Pumpable Gels
Magnesium
Hydroxide
Pastes
*Resuspendable Grade
Aluminum
Hydroxide
Magnesium
Carbonate
Powder
Magaldrate
Powder
0611* P.11
LV 9 P.13
LV 13 P.13
Hyper 10 P.13
Hyper 12 P.13
Aluminum
Hydroxide
Viscous Gels
Flogel* P.14
LVM P.14
Magnesium
Hydroxide
Pastes
*Pumpable Gel
*Pumpable Gel
Magaldrate
Gels
Visco 6* P.15
Visco 9 P.15
LVM P.17
M P.17
MG12* P.17
*Pumpable Gel
10% P.14
20% P.14
Magaldrate
Gels
10% P.17
20% P.17
Preformulated
CoBlend
Pumpable
Gels
*Micronized
7000 P.11
Aluminum
Phosphate Gel
Boehmite Gel
NLP 14 P.15
Preformulated
CoBlend
Pumpable
Gels
Antacid Suspensions
Grade
Grade
Grade
Dense powder,
USP, EP, Low lead
0200
Fine powder,
USP, EP
0.68-0.84
5100 is free flowing and blends very well with other ingredients.
It is low lead (<125 ppb).
0.16-0.25
0325
Denser powder,
USP, EP
5100
Grade
0.30-0.40
5200
Resuspendible powder,
USP, EP
0.60-0.75
Grade
5300
Dense powder,
USP, EP
0.60-0.90
10
Grade
0611
% Aluminum as Al2O3
39.0-44.0
Magaldrate Powder
Grade: 7000
Magaldrate is a highly reactive antacid designed for
formulation of suspensions and tablets. The high reactivity
of the product is a result of its unique crystal structure.
Grade
Apparent Density (g/mL)
NMT 0.20
% Magnesium as MgO
7000
% Magaldrate Assay
90.0-105.0
0.60-0.90
6.0-9.0
AHMC 0611 is specifically designed for rehydration from
the powdered form to a smooth, viscous, non-separating
suspension.
11
Antacid Suspensions
Grade
AMS 138
Ingredients
Al/Mg/Sorbitol
1.38
AMS 035
Ingredients
Al/Mg/Sorbitol
0.35
d(0.1):
118.887 m
d(0.5):
492.782 m
Grade
AMS 106
Ingredients
d(0.9):
Al/Mg/Sorbitol
1.06
CoBlend
AMS 123
Ingredients
Al/Mg/Sorbitol
Pass (%)
Grade
1.23
12
CoBlends
small particle
size yields
a good
mouthfeel.
100
90
80
70
60
50
40
30
20
10
0
Mean: 6.854
0.100
1.000
10.00
Size (microns)
100.0
1000
Simple Manufacturing
Process with
CoBlend Suspension
CoBlend
Manufacturing Process
with Separate Antacid
Suspension Components
Grade
LV 9
% Assay as Al(OH)3
12.5-15.3
% Assay as Al2O3
8.2-10.0
Viscosity
Add Water
Homogenization
Grade
LV 13
% Assay as Al(OH)3
19.1-21.4
Add Suspending Agent*
% Assay as Al2O3
12.5-14.0
Viscosity
Grade
Hyper 10
% Assay as Al(OH)3
13.0-15.3
Final Blend with suspending
agent*, flavor, preservatives,
other excipients and water
to produce desired antacid
concentration
QC for Release
QC for Release
Bottling Equipment
Bottling Equipment
Antacid Suspension
Antacid Suspension
% Assay as Al2O3
8.5-10.0
Viscosity
Grade
Hyper 12
% Assay as Al(OH)3
NLT 18.3
% Assay as Al2O3
NLT 12
Viscosity
13
Antacid Suspensions
Magaldrate Gels
Grade
Flogel
% Mg(OH)2 Assay
29.0-33.0
NMT 500
10%
Grade
% Magaldrate Assay
9.8-10.5
%Mg(OH)2 @ 100%
49.2-66.6
Grade
LVM
% Mg(OH)2 Assay
29.0-33.0
Grade
32.1-45.9
Viscosity, as-is, Haake mPas
NLT 50
20%
800-1800
% Magaldrate Assay
20.0-23.0
%Mg(OH)2 @ 100%
49.2-66.6
14
% Al(OH)3 @100%
% Al(OH)3 @100%
32.1-45.9
Viscosity, as-is, Haake mPas
NLT 50
Antacid Suspensions
Aluminum Phosphate
This product contains 20% aluminum phosphate (AlPO4) and
functions by coating the stomach wall. It does not neutralize
stomach acids. Aluminum phosphate absorbs gall salts and
stomach gas. Since the product does not chelate dietary
phosphate, it does not deplete phosphate from the stomach.
Grade
Gel 520
Characteristics
Pumpable Suspension
% Aluminum as AlPO4
19.0-21.0
Visco 6
Grade
% Assay as Al(OH)3
8.4-9.9
Boehmite Gel
Boehmite is a crystalline form of aluminum hydroxide. Unlike
the amorphous form of aluminum hydroxide gel, Boehmite
does not dissolve in Hydrochloric Acid (HCl). Boehmite protects
the stomach wall by absorbing stomach acid and creating a
high viscosity gel.
Grade
5.5-6.5
Viscosity
Visco 9
Grade
% Assay as Al(OH)3
NLP 14
% Assay as Al2O3
NLT 13.6
% Assay as Al2O3
NLT 8.9
Viscosity
Characteristics
% Al2O3 Content
Pumpable Suspension
14.0-16.0
15
Antacid Suspensions
Grade
AMS 106
Ingredients
CoBlend
Simple Manufacturing
Process with
CoBlend Suspension
Manufacturing Process
with Separate Antacid
Suspension Components
Al/Mg/Sorbitol
1.06
Grade
AMS 138
Ingredients
Al/Mg/Sorbitol
1.38
Homogenization
Blend to achieve
proper viscosity
Pass (%)
16
934.307 m
CoBlends
small particle
size yields
a good
mouthfeel.
100
90
80
70
60
50
40
30
20
10
0
Mean: 6.854
0.100
Add Water
1.000
10.00
Size (microns)
100.0
1000
QC for Release
QC for Release
Bottling Equipment
Bottling Equipment
Antacid Suspension
Antacid Suspension
Magaldrate Gel
Grade
10%
LVM
% Mg(OH)2 Assay
29.0-33.0
Grade
% Magaldrate Assay
Viscosity @ 7.75% cps
800-1800
Grade
% Mg(OH)2 Assay
29.0-33.0
%Mg(OH)2 @ 100%
49.2-66.6
Grade
1400-3000
32.1- 45.9
Viscosity, as-is, Haake mPas
NLT 50
20%
% Magaldrate Assay
Grade
9.8-10.5
% Al(OH)3 @100%
20.0-23.0
%Mg(OH)2 @ 100%
49.2-66.6
% Al(OH)3 @100%
32.1- 45.9
Viscosity, as-is, Haake mPas
NLT 50
MG12
% Mg(OH)2 Assay
10.0-14.0
1900-3000
17
Tablet
Wet Granulation
Aluminum
Hydroxide
Powders
0200* P.19
0325 P.19
Magnesium
Hydroxide
Powders
5100 P.19
5300 P.19
Aluminum
Hydroxide
Magnesium
Carbonate
Powders
0600 P.20
0652 P.20
Magaldrate
Powder
18
7000 P.20
Direct Compression
(No need for binder)
Aluminum
Hydroxide
Powder
Magnesium
Hydroxide
Powders
0312* P.26
*Binder needed,
Chilsonated
MS90 P.25
5112* P.25
*Binder needed,
Chilsonated
Preformulated
DC CoDried
Powders
AHMT1938 P.26
AHMH2743 P.26
AHMH3535*P.26
Calcium
Carbonate
Powders
CM90 P.21
CS90 P.22
CS95 P.23
Vitasmooth P.24
Antacid Tablets
Wet Granulation
Grade
Grade
Dense powder,
USP, EP, Low lead
0.16-0.25
0325
Denser powder,
USP, EP
5100
Tapped Density (g/mL)
0.68-0.84
5100 is free flowing and blends very well with other ingredients.
It is low lead (<125 ppb).
0200
Fine powder,
USP, EP
Grade
Grade
5300
Dense powder,
USP, EP
Tapped Density (g/mL)
0.30-0.40
0.60-0.90
19
Antacid Tablets
Wet Granulation
Grade
0600
% Aluminum as Al2O3
38.0-45.0
0.30-0.40
0652
34.0-38.0
% Magnesium as MgO
11.0-15.0
20
7000
% Magaldrate Assay
90.0-105.0
0.60-0.90
6.0-10.0
% Aluminum as Al2O3
Grade: 7000
Grade
% Magnesium as MgO
Grade
Magaldrate Powder
0.30-0.40
Antacid Tablets
DC Calcium Carbonate
Grade: CM90, CS90, CS95, Vitasmooth
CM90 calcium granulation is ideal for supplements requiring
a creamy mouth feel, high calcium carbonate assay, and high
density. Due to its high density and high assay, CM90 is ideal
for targeting lower tablet weights and lower tablet volumes,
while still providing the required calcium content. CM90 can be
used in both wet granulation and direct compression systems.
CM90
Grade
CM90
d(0.1):
Ingredients
Volume (%)
Calcium Carbonate
Maltodextrin
PSD 200 mesh
1.462
118.887 m
d(0.5):
492.782 m
d(0.9):
934.307 m
11
10
9
8
7
6
5
4
3
2
1
0
0.1
10
100
1000 3000
Fig 1. Compression
4.9
CM90
4.85
Thickness (mm)
4.8
4.75
4.7
4.65
4.6
4.55
4.5
4.45
0
10
15
20
25
30
35
21
Antacid Tablets
DC Calcium Carbonate
Grade: CM90, CS90, CS95, Vitasmooth
Grade
CS90*
Ingredients
Calcium Carbonate
Starch
73.109 m
d(0.5):
10
100
1000 3000
0.75-0.95
CS90
Fig 1. Compaction
25
CS90
20
15
10
0
10
15
20
25
30
CS90
Hardness (kP)
370.876 m
22
d(0.9):
175.005 m
11
10
9
8
7
6
5
4
3
2
1
0
0.1
CS90
Volume (%)
35
DC Calcium Carbonate
Grade: CM90, CS90, CS95, Vitasmooth
Grade
CS95
Ingredients
Calcium Carbonate
Starch
CS95
Volume (%)
24.128 m
d(0.5):
229.463 m
d(0.9):
435.612 m
11
10
9
8
7
6
5
4
3
2
1
0
0.1
10
100
1000 3000
PSD 60 mesh
6.5-43.2% retained
1.22
45.9-80.9% retained
CS95
Fig 1. Compression
CS95 is ideal when low volume, low weight and high calcium
dose swallow tablets are required.
4.9
CS95
4.8
Thickness (mm)
4.75
4.7
4.65
4.6
4.5
4.45
0
10
15
20
25
30
35
23
Antacid Tablets
DC Calcium Carbonate
Grade: CM90, CS90, CS95, Vitasmooth
Vitasmooth is a highly compactable and organoleptically
pleasing formulation of calcium carbonate specifically
designed for direct compression.
Grade
Vitasmooth
Fig 2. Friability
Vitasmooth
1.8
Vitasmooth
1.6
1.4
Ingredients
1.2
Friability (%)
Calcium Carbonate
Dextrose
Sucrose
MCC
Maltodextrin
1.0
0.8
0.6
0.4
0.2
0
PSD 60 mesh
0.80
Fig 1. Compaction
50
Vitasmooth
45
40
Hardness (kP)
35
30
25
20
15
10
5
0
0
10
15
20
25
30
24
35
10
15
20
25
30
35
Grade
MS90
Fig 1. Compaction
Hardness (kP)
35
30
25
20
15
10
5
0
5000
10000
15000
20000
25000
30000
Applications
Pharmaceutical
Direct Compression for Swallow or Chewable Tablets
+ Low ejection forces to save wear on tooling and tablet press
+ Low friability
+ High compressibility makes thinner swallow tablets
MS90
Ingredients
0.65-0.85 g/mL
% Moisture @ 105C
NMT 3
Buffering Agent
+ pH of 10 makes an ideal buffer to be used with APIs in a tablet
or capsule formulation to prevent active from acid degradation
+ May be used in antacid formulations
MS90 provides a high magnesium load for antacid activity
(acid neutralization). Customized products are available
upon request.
Grade
5112
Coarse granules,
USP, EP, Low lead
% Assay Mg(OH)2
95.0-100.0
25
Antacid Tablets
Grade
AHMH3535 & SF
Aluminum Assay
35% Al Hydrox DG
Magnesium Assay
35% Mg Hydrox
Tablet Type
Grade
AHMT1938
Aluminum Assay
19% Al Hydrox DG
Magnesium Assay
38% Mg Trisilicate
Grade
AHMH3535
AHMH2743
Aluminum Assay
27% Al Hydrox DG
Magnesium Assay
43% Mg Hydrox
Tablet Type
AHMH3535
12
Volume (%)
10
8
6
4
2
0
0.1
10
Particle Size (m)
26
100
1000 3000
DC CoDried
Wet granulation
Drying
Grade
Denser granules,
USP, EP
Sieving
0312
Apparent Density (g/mL)
0.60-0.75
27
28
Dosage Form
Suspension
Tablet
Laxative
Suspension
From Powder
Laxative
Suspension
From Paste
or Gel
Wet
Granulation
Direct
Compression
Magnesium
Hydroxide
Powder
Magnesium
Hydroxide
Pastes
Magnesium
Hydroxide
Powders
Magnesium
Hydroxide
Powders
5200* P.30
Flogel* P.30
LVM P.30
M P.31
MG12* P.31
5100 P.31
5300 P.31
MS90* P.32
5112 P.32
*Resuspendable powder
*Pumpable suspension
29
Laxative Suspension
Laxative Suspension
From Powder
Grade: 5200
Grade
5200
Resuspendible powder,
USP, EP
Grade
% Assay Mg(OH)2
95.0-100.0
Flogel
% Mg(OH)2 Assay
29.0-33.0
NMT 500
Grade
LVM
% Mg(OH)2 Assay
29.0-33.0
800-1800
30
Laxative Tablet
Wet Granulation
Grade
MG12
% Mg(OH)2 Assay
10.0-14.0
Grade
Viscosity @ 7.75% cps
1900-3000
Dense powder,
USP, EP
% Mg(OH)2 Assay
29.0-33.0
1900-3000
0.68-0.84
5300
Dense powder,
USP, EP
Viscosity @ 7.75% cps
5100 is free flowing and blends very well with other ingredients.
It is low lead (<125 ppb).
Grade
Grade
5100
0.60-0.90
31
Laxative Tablet
Direct Compression
Grade
MS90
Fig 1. Compactibility
Hardness (kP)
35
30
25
20
15
10
5
0
5000
10000
15000
20000
25000
30000
MS90
Ingredients
0.65-0.85 g/mL
% Moisture @ 105C
NMT 3
32
Grade
5112
Coarse granules,
USP, EP, Low lead
% Assay Mg(OH)2
95.0-100.0
33
Aluminum
Hydroxide
Gels
Aluminum Compounds
Aluminum Hydroxide
Al Hyd Gel
Visco 6
Al Hyd Gel
Visco 9 USP
Characteristics
Description
Physical
(2)(3)
Viscosity (Brookfield)
Chemical
NLT 13.7%
8.4 9.9%
NLT 9.0%
(2)
pH
5.5 6.5
5.5 8.0
(1)
NMT 4.7%
NMT 4.7%
(1)
NMT 0.8%
NMT 0.8%
(1)
NMT 10 ppm
NMT 10 ppm
(1)
NMT 83 ppm
NMT 83 ppm
E. Coli
Absence
Absence
% Expected ANC
Microbial
Other Notes
(1) These tests are on reduced testing status.
(2) These tests are measured on a 4.0 % Al2O3 or 6.12% Al(OH)3 suspension.
(3) These tests are measured at the time of release and are not indicative of stability.
This product is manufactured under cGMP conditions.
This product meets the Residual Solvents specification as described in USP Chapter <467>.
34
Al Hyd Gel
LV9 USP
Al Hyd Gel
LV13 USP
Al Hyd Gel
Hyper 10
Al Hyd Gel
Hyper 12 USP
12.5 15.3%
19.1 21.4%
13.0 15.3%
NLT 18.3%
8.2 10.0%
12.5 14.0%
8.5 10.0%
NLT 12.0%
5.5 8.0
5.5 8.0
5.5 8.0
5.5 8.0
NMT 4.7%
NMT 4.7%
NMT 4.7%
NMT 4.7%
NMT 0.8%
NMT 0.8%
NMT 10 ppm
NMT 10 ppm
NMT 10 ppm
NMT 10 ppm
NMT 83 ppm
NMT 83 ppm
NMT 83 ppm
NMT 83 ppm
Absence
Absence
Absence
Absence
NMT 0.8%
Other Notes
(1) These tests are on reduced testing status.
(2) These tests are measured on a 4.0 % Al2O3 or 6.12% Al(OH)3 suspension.
(3) These tests are measured at the time of release and are not indicative of stability.
This product is manufactured under cGMP conditions.
This product meets the Residual Solvents specification as described in USP Chapter <467>.
*Viscosity is tested using
Haake versus Brookfield.
35
Aluminum
Hydroxide
Powders
Aluminum Compounds
Aluminum Hydroxide
0200 Dried
Al Hyd Gel USP
0200 Dried
Al Hyd Gel Ph. Eur
Characteristics
Description
Physical
Tapped Density (Info only)
pH
NMT 10.0
(1)
Chlorides
NMT 0.85%
NMT 1.0%
(1)
Sulfate
NMT 0.6%
NMT 1.0%
(1)
Arsenic
NMT 8 ppm
NMT 4 ppm
(1)
Heavy Metals
NMT 0.006%
NMT 60 ppm
Neutralizing Capacity
NMT 35.0 mL
Other Notes
(1) These tests are on reduced testing status.
(2) These tests are measured on a 4.0 % Al2O3 or 6.12% Al(OH)3 suspension.
This product is manufactured under cGMP conditions.
36
This product meets the Residual Solvents specification as described in USP Chapter <467>.
0312 Dried
Al Hyd Gel
0325 Dried
Al Hyd Gel USP
0325 Dried
Al Hyd Gel Ph. Eur
47.0 60.0%
NMT 10.0
NMT 10.0
NMT 0.85 %
NMT 0.85%
NMT 1.0%
NMT 0.6%
NMT 0.6%
NMT 1.0%
NMT 4 ppm
NMT 8 ppm
NMT 4 ppm
NMT 0.006%
NMT 0.006%
NMT 60 ppm
NMT 35.0 mL
Other Notes
(1) These tests are on reduced testing status.
(2) These tests are measured on a 4.0 % Al2O3 or 6.12% Al(OH)3 suspension.
This product is manufactured under cGMP conditions.
This product meets the Residual Solvents specification as described in USP Chapter <467>.
37
Aluminum
Phosphate Gel
Boehmite Gel
Aluminum Compounds
Aluminum Phosphate/
Boehmite
Al Phosphate Gel,
520 Ph. Eur
Al Boehmite Gel,
NLP14
Characteristics
Description
Physical
(2)(3)
Viscosity (Haake)
Chemical
Aluminum Assay AlPO4
19.0 21.0%
14.0 16.0%
19.0% 23.0%
Soluble aluminum
NMT 50 ppm
Soluble phosphate
(2)
pH
Peroxides
NMT 50 ppm
7.5 9.5
6.0 8.0
NMT 150 ppm as H2O2
(1) (2)
Chlorides
NMT 0.25%
(1) (2)
Sulfate
NMT 0.2%
NMT 0.25%
(1) (2)
Arsenic
NMT 1 ppm
(1) (2)
Heavy Metals
NMT 10 ppm
NMT 5 ppm
pH @ 15 min is 2.0 2 .5
Microbial
Microbial Total Aerobic Count
E. Coli
Absence
Absence
Other Notes
(1) These tests are on reduced testing status.
(2) These tests are measured on a 4.0 % Al2O3 or 6.12% Al(OH)3 suspension.
This product is manufactured under cGMP conditions.
This product meets the Residual Solvents specification as described in USP Chapter <467>.
(3) These tests are measured at the time
of release and are not indicative of stability.
38
Magnesium
Hydroxide
Pastes
Magnesium Compounds
Magnesium Hydroxide
Mg Hyd Paste
USP LVM
Mg Hyd Paste
USP Type M
Flogel
USP
Mg Hyd
MG12
White to off-white
paste
White to off-white
paste
White to off-white
gel
29.0 33.0%
29.0 33.0%
29.0 33.0%
10.0 14.0%
NMT 1.5%
Characteristics
Description
Physical
*(3) Viscosity (Brookfield)
Chemical
Assay Mg(OH)2
(2)
Calcium @ 100%
NMT 1.5%
NMT 1.5%
NMT 1.5%
(2)
*Soluble Alkalies
NMT 1.0 mL
NMT 1.0 mL
NMT 1.0 mL
*Soluble Salts
NMT 12 mg
NMT 12 mg
NMT 12 mg
NMT 5 ppm
NMT 5 ppm
NMT 5 ppm
NMT 5 ppm
E. Coli
Absence
Absence
Absence
Absence
NMT 1.0 mL
Microbial
Other Notes
(1) These tests are on reduced testing status.
(*) These tests are performed on a 7.75% w/w Mg(OH)2 test suspension prepared from a Composite sample.
(2) These tests are calculated to a dry basis.
(3) These tests are measured at the time of release and are not indicative of stability.
This product is manufactured under cGMP conditions.
This product meets the Residual Solvents specification as described in USP Chapter <467>.
39
Magnesium
Hydroxide
Powders
Magnesium Compounds
Magnesium Hydroxide
5100 CG Mg Hyd
Powder USP
DC Magnesium Hyd
MS90
White to off-white
granular powder
Characteristics
Description
Physical
Tapped Density (Info only)
Chemical
Assay (dried @ 105 deg C for 2 hrs)
Loss on Drying
NMT 2.0%
NMT 2.0%
NMT 3.0%
30.0 33.0%
30.0 33.0%
(2)(3)
(2)
Calcium @ 100%
NMT 1.5%
NMT 1.5%
(1)
Heavy Metals
NMT 20 ppm
NMT 20 ppm
Absence
Absence
Soluble Substances
Absence
Other Notes
(1) These tests are on a reduced testing status.
(2) These tests are calculated to a dry basis.
This product is manufactured under cGMP conditions.
This product meets the Residual Solvents specification as described in USP Chapter <467>.
40
5300 Mg Hyd
USP
5300 Mg Hyd
Ph. Eur
NMT 2.0%
30.0 33.0%
NMT 2.0%
29.0 32.5%
30.0 33.0%
29.0 32.5%
NMT 1.5%
NMT 1.5%
NMT 1.5%
NMT 1.5%
NMT 20 ppm
NMT 30 ppm
NMT 20 ppm
NMT 30 ppm
Absence
NMT 2.0%
NMT 2.0%
NMT 0.1%
NMT 0.1%
NMT 0.1%
NMT 0.1%
NMT 1.0%
NMT 1.0%
NMT 0.07%
NMT 0.07%
NMT 4 ppm
NMT 4 ppm
Absence
Absence
Absence
Other Notes
(1) These tests are on a reduced testing status.
(2) These tests are calculated to a dry basis.
This product is manufactured under cGMP conditions.
This product meets the Residual Solvents specification as described in USP Chapter <467>.
(4) These tests are measured at the time of release and are not indicative of stability.
41
Aluminum
Hydroxide
Magnesium
Carbonate
0611 Al Hyd/
Mg Carb
0652 Al Hyd/
Mg Carb
38.0 45.0%
39.0 44.0%
34.0 38.0%
Assay MgO
6.0 10.0%
6.0 9.0%
11.0 15.0%
pH
8.5 9.5
8.5 9.5
8.5 9.5
NLT 25 mEq/g
NLT 25 mEq/g
NLT 25 mEq/g
Chloride
NMT 0.85%
NMT 0.20%
NMT 0.20%
Sulfate
NMT 0.6%
NMT 0.6%
NMT 0.6%
Arsenic
NMT 8 ppm
NMT 5 ppm
NMT 5 ppm
Heavy Metals
NMT 60 ppm
NMT 50 ppm
NMT 50 ppm
E. Coli
Absence
Absence
Absence
Aluminum Hydroxide/
Magnesium Carbonate
Characteristics
Description
Physical
Apparent Density (Info only)
Chemical
Microbial
Other Notes
This product is manufactured under cGMP conditions.
This product meets the Residual Solvents specification as described in USP Chapter <467>.
42
Magaldrate
Gels &
Powders
Magaldrate
Fluid Gel 10%
Magaldrate
Fluid Gel 20%
7000 Mgal
Powder USP
7000 Mgal
Powder EP
White or almost
white, crystalline
powder
White or almost
white, crystalline
powder
50 100 mPas
50 150 mPas
9.8% 10.5%
20.0% 23.0%
90.0% 105.0%
90.0% 105.0%
Characteristics
Description
Physical
(3)
Viscosity (Haake)
Chemical
% Magaldrate
(2)
Al2O3 in Magaldrate
32.1% 45.9%
32.1% 45.9%
32.1% 45.9%
32.1% 45.9%
(2)
Mg(OH)2 in Magaldrate
49.2% 66.6%
49.2% 66.6%
49.2% 66.6%
49.2% 66.6%
(1)
Sulfates
16.0% 21.0%
16.0% 21.0%
16.0% 21.0%
16.0% 21.0%
(1)
Soluble Sulfates
NMT 1.9%
NMT 1.9%
NMT 1.9%
NMT 1.9%
(1)
Soluble Chlorides
NMT 3.5%
NMT 3.5%
NMT 3.5%
NMT 3.5%
(1)
Arsenic
NMT 8 ppm
NMT 8 ppm
NMT 8 ppm
(1)
Heavy Metals
NMT 60 ppm
NMT 60 ppm
NMT 0.006%
NMT 30 ppm
Loss on Drying
10.0% 20.0%
10.0% 20.0%
Sodium
NMT 0.11%
NMT 0.10%
Microbial
Microbial Total Aerobic Count
E. Coli
Absence
Absence
Absence
Absence
Other Notes
(1) These tests are on a 100% Magaldrate basis.
(2) These tests are calculated to a dry basis.
(3) These tests are measured at the time of release and are not indicative of stability.
This product is manufactured under cGMP conditions.
This product meets the Residual Solvents specification as described in USP Chapter <467>.
43
Preformulated
CoBlend
Pumpable
Gels
AMS 035
AMS 106
AMS 123
AMS 138
White to off-white
suspension
White to off-white
suspension
White to off-white
suspension
White to off-white
suspension
12.7 14.9%
9.2 10.8%
11.2 13.0%
8.2 9.5%
8.3 9.7%
6.0 7.1%
7.3 8.5%
5.4 6.2%
Assay Mg(OH)2
4.1 4.8%
9.2 10.8%
13.1 15.1%
10.8 12.5%
Assay MgO
2.8 3.3%
6.4 7.5%
9.1 10.4%
7.5 8.6%
pH
7.3 8.5
7.5 8.5
7.5 8.8
7.3 8.5
Sorbitol
2.0 4.0%
6.7 8.0%
4.9 6.1%
6.7 8.0%
Arsenic
Chloride
NMT 0.23%
NMT 0.35%
NMT 0.23%
NMT 0.23%
Heavy Metals
NMT 5 ppm
NMT 5 ppm
NMT 5 ppm
NMT 7 ppm
Sulfate
NMT 0.1%
NMT 0.1%
NMT 0.17%
Characteristics
Description
Chemical
Microbial
Microbial Total Aerobic Count
E. Coli
Absence
Absence
Absence
Absence
Other Notes
This product is manufactured under cGMP conditions.
44
Preformulated
DC CoDried
Powders
AHMH 3535
AHMH 2743
AHMH 3535
White to creamy
white, odorless,
sweet taste powder
White to creamy
white, odorless,
sweet taste powder
White to creamy
white, odorless,
sweet taste powder
12.1 14.7%
16.4 19.0%
16.4 19.0%
9.2 11.2%
24.2 29.4%
32.8 38.0%
32.8 38.0%
18.4 22.4%
38.6 47.2%
32.8 38.0%
32.8 38.0%
AHMT 1938
Characteristics
Description
White to creamy
white, odorless,
sweet taste powder
Physical
Tapped Density (Info only)
Chemical
Aluminum Assay Al2O3
As Al(OH)3 dried gel USP at 50.0% Al2O3
Assay Mg(OH)2
8.0 9.8%
Assay MgO
34.2 41.8%
0.297 0.328
0.475 0.525
0.475 0.525
1.092 1.208
NMT 5.0%
3.5 5.0%
NMT 6.0%
NMT 6.0%
NLT 90 mL HCl
0.1/1 tablet eq.
E. Coli
Absence
Absence
Absence
Absence
Other Notes
This product is manufactured under cGMP conditions.
45
Calcium
Carbonate
Powders
Calcium Compounds
DC Calcium Carbonate
CM90
CS90
CS95
Vitasmooth
White to off-white
granular powder
White to off-white
free flowing powder
White to off-white
free flowing powder
6.5 43.2%
Retained
NLT 25%
Retained
45.9 80.9%
Retained
NMT 10%
Retained
92.0 98.0%
54.0 60.0%
KF Water
0.4 1.5%
NMT 3%
Water Activity
NMT 0.7
Characteristics
Description
Physical
Tapped Density (Info only)
PSD 60 mesh
NLT 60%
Through
NMT 25%
Through
NMT 25%
Through
88.0 93.0%
85.5 95.5%
Loss on Drying
NMT 1%
NMT 2%
Microbial
Microbial Total Aerobic Count
Other Notes
This product is manufactured under cGMP conditions.
46
0312
27, 37
25, 32, 40
0325
10, 19, 37
10, 30, 41
25, 32, 40
MS90
13, 35
Hyper 12
13, 35
LV 9
13, 35
Flogel
LV 13
13, 35
LVM
Visco 6
15, 34
17, 31, 39
Visco 9
15, 34
MG12
17, 31, 39
CoBlend Suspension
14, 30, 39
14, 17, 30, 39
AHMC
AMS 035
12, 44
0600
20, 42
AMS 106
12, 16, 44
0611
11, 42
AMS 123
12, 44
0652
20, 42
AMS 138
12, 16, 44
Magaldrate Gels
DC Calcium Carbonate
10%
14, 17, 43
CM 90
21, 46
20%
14, 17, 43
CS 90
22, 46
11, 20, 43
CS 95
23, 46
Vitasmooth
24, 46
DC CoDried Powders
AHMT 1938
26, 45
AHMH 2743
26, 45
AHMH 3535
26, 45
26, 45
15, 38
15, 38
47
7
4
8
1
3
10
9
5
6
11
Americas
Europe/Africa/Middle East
Asia/Pacic
1
2
3
4
5
6
Australia
11 Anzchem Sydney, Australia Sales
Americas
SPI Pharma, Inc.
Rockwood Ofce Park
503 Carr Rd., Suite 210
Wilmington, DE 19809
Asia/Pacic
SPI Pharma, Inc India Branch
21 B, Veerasandra Industrial Area
Hosur Road, Bangalore 560100
Karnataka, India
T 33 4 9196 3600
F 33 4 9196 3633
salesinfo@
spipharma.com
T 61 2 9475 2200
F 61 2 9475 2211
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