Parameters |
Specification |
Color |
White |
Solubility |
Practically insoluble in water, dilute acid and most of organic solvents, Slightly soluble in dilute NaOH solution |
Identification A (USP/BP), B (EP),1 (JP) |
Have to correspond as USP/NF, JP,Ph.Eur.,BP |
Identification A (EP) |
Have to correspond as Ph. Eur. |
Identification B (USP/BP), 3(JP), C (EP) (Degree of Polymerization) |
NMT 350 as USP/NF,JP,Ph.Eur.,BP |
Identification 2 (JP) |
Have to correspond as JP |
Solubility (coppertetramine solution) |
Have to correspond as Ph.Eur., BP |
pH |
5.0-7.5 asUSP/NF,JP,Ph.Eur.,BP |
Conductivity |
NMT 75 µS.cm-1as USP/NF,JP,Ph.Eur.,BP |
Water- Soluble Substance |
NMT 0.25% as USP/NF,JP,Ph.Eur.,BP |
Ether- Soluble Solution |
NMT 0.05% as USP/NF,JP,Ph.Eur.,BP |
Loss on Drying |
NMT 7.0% as USP/NF,JP,Ph.Eur.,BP |
Heavy Metals |
NMT 10 PPM as USP/NF,JP,Ph.Eur.,BP |
Residue on Ignition/Sulphated Ash |
NMT 0.1% as USP/NF,JP,Ph.Eur.,BP |
Residue on Ignition/Sulphated Ash |
NMT 0.1% as USP/NF,JP,Ph.Eur.,BP |
Organic volatile Impurities |
To comply the tests as per method IV. (USP) |
Assay (Dried) |
97.0 – 102.0(IP) |
Arsenic |
NMT 2 PPM as IP |
Starch & Dextrin |
Should comply the test as IP |
Organic Impurities |
Should comply the test as IP |
MICROBIAL LIMITS
Total Viable Aerobic Count |
N.M.T. 1000/g as USP/NF, Ph.Eur., BP |
Total yeast& Mould Count |
N.M.T 100/g as USP/NF, Ph.Eur., BP |
Staphylococcus aureus |
Absent as USP/NF, Ph.Eur., BP |
Escherichia Coli. |
Absent asUSP/NF, Ph.Eur., BP |
Pseudomonas aeruginosa |
Absent as USP/NF, Ph.Eur., BP |
Salmonella species |
Absent as USP/NF, Ph.Eur., BP |
The raw materials, manufacturing process, and product do not contain any of solvents listed in Organic Volatile Impurities (USP<467>) & residual solvents (Ph – Eur<5.4>
Storage recommendation: Preserve in tight containers.
GRADES |
PARTICLE SIZE DISTRIBUTION |
BULK DENSITY |
MOISTURE |
PARTICLE SIZE |
D10 |
D50 |
D90 |
APS# |
(GM/ML) |
(%WW) |
> 60 MESH |
> 100 MESH |
> 200 MESH |
(MIC) |
(MIC) |
(MIC) |
(MIC) |
AMCELL101 |
≤30 |
40-60 |
≥80 |
50 |
0.26-0.34 |
NMT 7.0% |
≤ 1 % |
- |
≤ 30 % |
AMCELL102 |
≤45 |
70-100 |
≥140 |
90 |
0.27-0.34 |
NMT 7.0% |
≤ 8 % |
|
≥ 45 % |
AMCELL103 |
≤30 |
40-60 |
≥80 |
50 |
0.26-0.34 |
NMT 3.0% |
≤ 1 % |
- |
≤ 30 % |
AMCELL105 |
02 – 10 |
10 - 30 |
20 - 60 |
20 |
0.20-0.30 |
NMT 5.0% |
Passes through 400 Mesh ≥ 90 % |
AMCELL112 |
≤45 |
70-100 |
≥140 |
90 |
0.28-0.34 |
NMT 1.5% |
≤ 8 % |
- |
≥ 45 % |
AMCELL12 |
≤50 |
100-140 |
≥200 |
110 |
0.27-0.34 |
NMT 7.0% |
38 Mesh ≤ 0.5% |
94 Mesh ≤ 50 % |
300 Mesh ≥ 70% |
AMCELL14 |
≤50 |
100-140 |
≥200 |
110 |
0.27-0.34 |
NMT 1.5% |
AMCELL113 |
≤30 |
40-60 |
≥80 |
50 |
0.28-0.34 |
NMT 1.5% |
≤ 1 % |
- |
≤ 30 % |
AMCELL200 |
≤70 |
150-200 |
≥260 |
180 |
0.31-0.39 |
NMT 7.0% |
≥ 10 % |
≥ 50 % |
- |
AMCELL200 LM |
≤70 |
150-200 |
≥260 |
180 |
0.31-0.39 |
NMT 1.5% |
≥ 10 % |
≥ 50 % |
- |
AMCELL250 |
- |
- |
- |
- |
0.31-0.39 |
NMT 7.0% |
≥ 30 % |
≥ 60 % |
- |
AMCELL301 |
≤30 |
40-60 |
≥80 |
50 |
0.35-0.45 |
NMT 7.0% |
≤ 1 % |
- |
≤ 30 % |
AMCELL302 |
≤45 |
70-100 |
≥140 |
90 |
0.35-0.45 |
NMT 7.0% |
≤ 8 % |
- |
≥ 45 % |
AMCELL101 FP |
≤30 |
40-60 |
≥80 |
50 |
0.26-0.34 |
NMT 5.0% |
≤ 1 % |
- |
≤ 30 % |
AMCELL102 HD |
≤45 |
70-100 |
≥140 |
90 |
0.30-0.36 |
NMT 7.0% |
≤ 8 % |
- |
≥ 45 % |
- a. Brightness for all grades = >88%
- c. NMT- Not more than
GRADES |
PARTICLE SIZE DISTRIBUTION |
BULK DENSITY |
MOISTURE |
PARTICLE SIZE |
D10 |
D50 |
D90 |
APS# |
(GM/ML) |
(%WW) |
> 60 MESH |
> 100 MESH |
> 200 MESH |
(MIC) |
(MIC) |
(MIC) |
(MIC) |
AMCELL101 PLUS |
≤30 |
40-60 |
≥80 |
50 |
0.26-0.31 |
3.0 - 5.0% |
≤ 1 % |
- |
≤ 30 % |
AMCELL102 PLUS |
≤45 |
70-100 |
≥140 |
90 |
0.28-0.33 |
3.0 - 5.0% |
≤ 8 % |
|
≥ 45 % |
AMCELL103 PLUS |
≤30 |
40-60 |
≥80 |
50 |
0.26-0.31 |
NMT 3.0% |
≤ 1 % |
- |
≤ 30 % |
AMCELL105 PLUS |
02 – 10 |
10 - 30 |
20 - 60 |
20 |
0.20-0.30 |
NMT 5.0% |
Passes through 400 Mesh ≥ 99.5 % |
AMCELL112 PLUS |
≤45 |
70-100 |
≥140 |
90 |
0.28-0.33 |
NMT 1.5% |
≤ 8 % |
- |
≥ 45 % |
AMCELL12 PLUS |
≤50 |
100-140 |
≥200 |
110 |
0.28-0.33 |
3.0 - 5.0% |
38 Mesh ≤ 1 % |
94 Mesh ≤ 50 % |
300 Mesh ≥ 70% |
AMCELL14 PLUS |
≤50 |
100-140 |
≥200 |
110 |
0.28-0.33 |
NMT 1.5% |
AMCELL113 PLUS |
≤30 |
40-60 |
≥80 |
50 |
0.26-0.31 |
NMT 1.5% |
≤ 1 % |
- |
≤ 30 % |
AMCELL200 PLUS |
≤70 |
150-200 |
≥260 |
180 |
0.31-0.39 |
3.0 - 5.0% |
≥ 10 % |
≥ 50 % |
- |
AMCELL250 PLUS |
- |
- |
- |
- |
0.31-0.39 |
3.0 - 5.0% |
≥ 30 % |
≥ 60 % |
- |
AMCELL301 PLUS |
≤30 |
40-60 |
≥80 |
50 |
0.35-0.45 |
3.0 - 5.0% |
≤ 1 % |
- |
≤ 30 % |
AMCELL302 PLUS |
≤45 |
70-100 |
≥140 |
90 |
0.35-0.45 |
3.0 - 5.0% |
≤ 8 % |
|
≥ 45 % |
- a. Brightness for all grades = >92%
Grade |
Usage |
AMCELL-101 |
AMCELL-101 is most widely used for direct compression tableting and wet granulation. |
AMCELL-102 |
AMCELL-102 has similar compression properties to AMCELL-101. However, it has larger particle size and therefore, may be of value in improving the flow if fine powders. |
AMCELL-12 |
AMCELL-12 has larger particle size and therefore, value in improving the flow property. |
AMCELL-103
AMCELL-112
AMCELL-113
AMCELL-200 LM
AMCELL-14 |
AMCELL-103, AMCELL-112, AMCELL-113,AMCELL-200 LM and AMCELL-14 have reduced moisture content and are ideal for use with moisture sensitive materials. |
AMCELL-105 |
AMCELL-105 has the finest particle size and may be used in direct compressing of coarser, granular and crystalline materials. AMCELL-105's enhanced compressibility characteristics make it ideally suitable for application involving difficult to compress materials. It can be admixed with AMCELL-101 or AMCELL-102 to achieve specific flow and/or compression properties. |
AMCELL-200 |
AMCELL-200 has a large particle size which offers increased flow ability with minimum effect on compression characteristics. It can be used in direct compression and wet granulation to reduce table weight variation and to improve content uniformity. |
AMCELL-250 |
AMCELL-250 has a large particle size than AMCELL 200 which offers increased flow ability with minimum effect on compression characteristics than AMCELL 250. |
AMCELL-301 |
AMCELL-301 has a higher density then its size equivalent, AMCELL-101, providing increased flow ability, greater tablet weight uniformity and the potential for making smaller tablets. |
AMCELL-302 |
AMCELL-302 has the density characteristics of AMCELL-301 with a particle size of AMCELL-102. Like AMCELL-301, AMCELL-302 offers increased flow ability, greater tablet weight uniformity and the potential for smaller tablets. |
(1) PHARMACEUTICALS |
|
- Filler
- Binder
- Disintegrant
- Lubricant
|
(2) FOOD |
|
1. Bakery |
|
- Anticaking agent
- Fat replacement
- Heat stabilizer
- Flow control
- Excellent creamy mouth feel
- Flavour release
- Prevent separation of oil & water
- Improved texture
- Bulking agent
|
|
2. Fluids |
|
- Suspension stabilizer
- Improves creaminess
- Fat replacement
- Improves mouth feel
- Flavour release
- Opacifier
- Heat stabilizer
|
|
3. Dairy |
|
- Ice crystal control
- Texture modification
- Lower fat
- Form stabilizer
- Prevent water loss
- Emulsion stabilizer
- Opacifier
|
|
4. Extrusition |
|
- Low calorie
- Improves texture
- Moisture control
- Heat stabilizer
|
|
5. Vegetarian food |
|
- Frozen thaw stabilizer
- Improve mouth feel
- Moisture control
|
(3) COSMETIC |
|
- Thickener
- Binder
- Abrasive
- Absorbent
- Adhesive
- Anticaking agent
- Bulking agent
- Emulsion stabilizer
- Opacifying agent
- Slip modifier
|
(4) WELDING ELECTRODES |
|
- Binder
- Prevent cracks on body of rods
- Provide good texture
- Provides inert gas atmosphere at the time of welding.
|
(5) PAINTS |
|
- Thickener
- Controls viscosity
- Emulsifier
- Improve compressive strength
- Absorbs moisture and prevents clogging
|
(6) CEMENT & CERAMICS |
|
- Improve compressive strength
- Absorbs moisture and prevents clogging
|
(7) RUBBER |
|
- Reduction in mooney viscosity
- Enhance plasticity
- Reduce aromatic oil content
- Can partially replace silica
|
(8) FILTRATION AID |
|
- Used in almost all filtration processes
- Used in petroleum industries as filtering aid, for metal filtration
|
(9) FEED |
|
- To boost the energy content of fodder
- Utilized for energy by ruminants
- Dietary supplement for poultry & Pig
- Additive to animal feed
|