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“Mendonyl™ is an extraordinary reflection of the pharmaceutical
and nutritional industry’s need for advancement
in developing an economical and quality Povidone and Crospovidone.”
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[title type=”subtitle h3″ color=”red” class=”nbm hb-alignleft”]Mendonyl™[/title]
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The Pharmaceutical Formulator’s Choice Tablet Binder and Disintegrate
Povidone – Crospovidone
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MENDONYL™ Povidone
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MENDONYL™ Crospovidone
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Mendonyl™ Povidone
K17, K25, K30, K90
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SAMPLE DENSITIES
| Product name | Typical Bulk density(g/ml) | Typical tapped density(g/ml) |
| Mendonyl™ XL | 0.20-0.30 | 0.30-0.40 |
| Mendonyl™ XL-10 | 0.20-0.30 | 0.30-0.40 |
| Product name | Typical Bulk density(g/ml) | Typical tapped density(g/ml) |
| Mendonyl™ K25 | 0.40-0.50 | 0.50-0.60 |
| Mendonyl™ K30 | 0.40-0.50 | 0.50-0.60 |
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Mendonyl™ Crospovidone
XL, XL-10
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MICROBIOLOGICAL STATUS
| MAX 100 Aerobic Plate Count CFU/g | ||
| MAX 100 Mold and Yeast CFU/g | ||
| No Escherichia /g | ||
| No Pseudomonas aeruginosa /g | ||
| No Salmonella /10g | ||
| No Staphylococcus aureus /g |
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SPECIFICATIONS AND BENCHMARK
Mendonyl™ Povidone K25
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| K25 | |||
| TEST | Mendonyl™ | Competitor A | Competitor B |
| Identification, A B C D E | Complies | Complies | Complies |
| Appearance of solution | Clear, ≤B6,BY6 or R6 | Clear, ≤B6,BY6 or R6 | Lighter than, ≤B6,BY6 or R6 |
| PH(in 5% solution) | 3-5 | 3-5 | 3-5 |
| Viscosity, as K-value | 22.5-27 | 22.5-27 | 24-26 |
| Aldehyde, ppm | ≤500 | ≤500 | ≤500 |
| Peroxides (as H2O2), ppm | ≤400 | ≤400 | ≤400 |
| Formic Acid, % | ≤0.5 | ≤0.5 | ≤0.5 |
| Hydrazine, ppm | ≤1 | ≤1 | ≤1 |
| Impurity A (VP),ppm | ≤10 | ≤10 | ≤5.0 |
| Impurity B (2-pyrrolidone ),% | ≤3.0 | ≤3.0 | ≤3.0 |
| Heavy metals, ppm | ≤10 | ≤10 | ≤10 |
| Water, % | ≤5.0 | ≤5.0 | ≤5.0 |
| Sulphated ash,% | ≤0.1 | ≤0.1 | ≤0.1 |
| Assay, as Nitrogen content,% | 11.5-12.8 | 11.5-12.8 | – |
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SPECIFICATIONS AND BENCHMARK
Mendonyl™ Povidone K30
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| K30 | |||
| TEST | Mendonyl™ | Competitor A | Competitor B |
| Identification, A B C D E | Complies | Complies | Complies |
| Appearance of solution | Clear, ≤B6,BY6 or R6 | Lighter than, ≤B6,BY6 or R6 | Lighter than, ≤B6,BY6 or R6 |
| PH(in 5% solution) | 3-5 | 3-5 | 3-5 |
| Viscosity, as K-value | 27-32.4 | 27-32.4 | 29-32 |
| Aldehyde, ppm | ≤500 | ≤500 | ≤500 |
| Peroxides (as H2O2), ppm | ≤400 | ≤400 | ≤400 |
| Formic Acid, % | ≤0.5 | ≤0.5 | ≤0.5 |
| Hydrazine, ppm | ≤1 | ≤1 | ≤1 |
| Impurity A (VP),ppm | ≤10 | ≤10 | ≤5.0 |
| Impurity B (2-pyrrolidone ),% | ≤3.0 | ≤3.0 | ≤3.0 |
| Heavy metals, ppm | ≤10 | ≤10 | ≤10 |
| Water, % | ≤5.0 | ≤5.0 | ≤5.0 |
| Sulphated ash,% | ≤0.1 | ≤0.1 | ≤0.1 |
| Assay, as Nitrogen content,% | 11.5-12.8 | 12.0-12.8 | – |
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SPECIFICATIONS AND BENCHMARK
Mendonyl™ Povidone K90
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| K90 | |||
| TEST | Mendonyl™ | Competitor A | Competitor B |
| Identification, A B C D E | Complies | Complies | Complies |
| Appearance of solution | Clear, ≤B6,BY6 or R6 | Lighter than, ≤B6,BY6 or R6 | Lighter than, ≤B6,BY6 or R6 |
| PH(in 5% solution) | 4-7 | 4-7 | 4-7 |
| Viscosity, as K-value | 81-97 | 81-96.3 | 85-95 |
| Aldehyde, ppm | ≤500 | ≤500 | ≤500 |
| Peroxides (as H2O2), ppm | ≤400 | ≤400 | ≤400 |
| Formic Acid, % | ≤0.5 | ≤0.5 | ≤0.5 |
| Hydrazine, ppm | ≤1 | ≤1 | ≤1 |
| Impurity A (VP),ppm | ≤10 | ≤10 | ≤10 |
| Impurity B (2-pyrrolidone ),% | ≤3.0 | ≤3.0 | ≤1 |
| Heavy metals, ppm | ≤10 | ≤10 | ≤10 |
| Water, % | ≤5.0 | ≤5.0 | ≤5.0 |
| Sulphated ash,% | ≤0.1 | ≤0.1 | ≤0.1 |
| Assay, as Nitrogen content,% | 11.5-12.8 | 12.0-12.8 | – |
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SPECIFICATIONS AND BENCHMARK
Mendonyl™ Crospovidone XL
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| TEST | Mendonyl™ XL | Competitor A | Competitor B |
| Identification, A B C | Pass | Pass | Pass |
| Identification D | Type A | Type A | Type A |
| Solubility (Insoluble in ) | practically insoluble in water | ||
| PH ( in 1% suspension ) | 5.0 – 8.0 | 5.0 – 8.0 | 5.0 – 8.0 |
| Loss on drying | ≦5.0% | ≦5.0% | ≦5.0% |
| Water | ≦5.0% | ≦5.0% | ≦5.0% |
| Water-soluble matter | ≦1.0% | ≦1.0% | ≦1.0% |
| Acid-Alcohol soluble matter | ≦1.0% | ≦1.0% | ≦1.0% |
| Peroxides ( as H2O2 ) | ≦400ppm | ≦400ppm | ≦400ppm |
| Free N-vinylpyrrolidone | ≦10ppm | ≦10ppm | ≦5ppm |
| Residue on ignition | ≦0.1% | ≦0.1% | ≦0.1% |
| Heavy metals | ≦10ppm | ≦10ppm | ≦5ppm |
| Assay, as Nitrogen content | 11.0 – 12.8 | 12.0 – 12.8 | 11.0 – 12.8 |
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SPECIFICATIONS AND BENCHMARK
Mendonyl™ Crospovidone XL-10
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| TEST | Mendonyl™ XL-10 | Competitor A | Competitor B |
| Identification, A B C | Pass | Pass | Pass |
| Identification D | Type A | Type A | Type A |
| Solubility (Insoluble in ) | practically insoluble in water | ||
| PH ( in 1% suspension ) | 5.0 – 8.0 | 5.0 – 8.0 | 5.0 – 8.0 |
| Loss on drying | ≦5.0% | ≦5.0% | ≦5.0% |
| Water | ≦5.0% | ≦5.0% | ≦5.0% |
| Water-soluble matter | ≦1.0% | ≦1.0% | ≦1.0% |
| Acid-Alcohol soluble matter | ≦1.0% | ≦1.0% | ≦1.0% |
| Peroxides ( as H2O2 ) | ≦400ppm | ≦400ppm | ≦400ppm |
| Free N-vinylpyrrolidone | ≦10ppm | ≦10ppm | ≦5ppm |
| Residue on ignition | ≦0.1% | ≦0.1% | ≦0.1% |
| Heavy metals | ≦10ppm | ≦10ppm | ≦5ppm |
| Assay, as Nitrogen content | 11.0 – 12.8 | 12.0 – 12.8 | 11.0 – 12.8 |
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