[title type=”extra-large” color=”#000000″]Mendonyl™ Povidone (PVP)[/title]
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[icon_feature icon=”hb-moon-eye-2″ icon_position=”center” border=”yes” title=”Wet Granulation”]As illustrated in countless studies (visit our BLOG for more), PVP is widely accepted as the finest binder available for a comprehensive array of formulations that require wet granulation. Its critical impact to the pharmaceutical formulation of small molecule drugs is well-known.[/icon_feature]
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[icon_feature icon=”hb-moon-brain” icon_position=”center” border=”yes” title=”Flexibility”]Prevent failure by taking advantage of PVP’s ability to adapt to active compounds in tablets and many other dosage forms, while maintaining stability and quality through all the rigorous production processes, including Spray-drying and roller compaction. With a wide usage range (as low as 1%), achieving solid powders that are easily compressed into tablets and don’t break apart, is at the core of this adaptive binder.[/icon_feature]
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[icon_feature icon=”hb-moon-palette” icon_position=”center” border=”yes” title=”Tough”]Recognized, peer-reviewed backed science, means the production of tablets that are easily compressed, and rapidly dissolve in the stomach.
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WHAT IS POVIDONE?
Commonly Povidone (polyvinylpyrrolidone), or simply PVP, is a polymer produced from the monomer, N-vinylpirrolidone, when single molecular units unite to form long polymer chains – a process referred to as “polymerization.” The resulting polymer is an extremely versatile substance, which is used in a great variety of industries, particularly in the pharmaceutical industry, as a binder, film-former, and solubilizing agent. LEARN MORE AT OUR BLOG.
MENDONYL™ K25, K30, K90
Almost white free-flowing powder.
They have a slight characteristic odor, and are practically tasteless.
| TEST | K25 | K30 | K90 |
| Identification, A B C D E | Complies | Complies | Complies |
| Appearance of solution | Clear, ≤B6,BY6 or R6 | Clear, ≤B6,BY6 or R6 | Clear, ≤B6,BY6 or R6 |
| PH(in 5% solution) | 3-5 | 3-5 | 4-7 |
| Viscosity, as K-value | 22.5-27 | 27-32.4 | 81-97 |
| 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 | ≤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 | 11.5-12.8 |
MENDONYL™ K25, K30, K90
| 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 | ||||
Freely soluble in water and many organic compounds.
Nifedipine Tablets
| Ingredients | mg/tab |
| Nifedipine | 10 |
| Povidone (K-25) | 36 |
| Methylene chloride | 168 |
| Microcrystalline cellulose 102 | 116 |
| Cornstarch | 125 |
| Crospovidone | 23 |
| Magnesium stearate | .36 |
| Nimesulide | 100 |
Cefdinir Tablets
| Ingredients | mg/tab |
| Cefdinir bulk powder | 306.8 |
| Microcrystalline cellulose 101 | 29.2 |
| L-HPC (LH-21, Shin-Etsu Chemical) | 29.2 |
| Povidone (K30) | 3.7 |
| Colloidal silicon dioxide | 0.9 |
| Magnesium stearate | 4.4 |
| Saccharin sodium | 15 |
| Strawberry flavor | 5.6 |
Metamizol Tablets (500 mg)
| Ingredients | mg/tab |
| Metamizol sodium (dipyrone) | 500 |
| Microcrystalline cellulose 101 | 100 |
| Povidone (K30) | 15 |
| Crospovidone | 25 |
| Colloidal silicon dioxide | 1 |
| Talc | 8 |
| Calcium arachinate | 1 |
Chloroquine Tablets (250 mg)
| Ingredients | mg/tab |
| Chloroquine diphosphate | 250 |
| Dicalcium phosphate (Ditab) | 100 |
| Povidone (K30) | 10 |
| Isopropyl alcohol | 83 |
| Crospovidone | 10 |
| Colloidal silicon dioxide | 2 |
| Talc | 3 |
Vitamin B-Complex, Vitamin C, and Vitamin E Tablets
| Ingredients | mg/tab |
| Niacinamide, (white powder), USP | 100 |
| Ascorbic acid; use sodium ascorbate (microcrystalline), USP | 843.65 |
| Calcium pantothenate, USP | 30 |
| Riboflavin, USP | 10 |
| Pyridoxine hydrochloride, USP | 5.25 |
| Povidone (K-90) | 5.5 |
| Anhydrous isopropyl alcohol | 68 |
| Thiamine mononitrate (powder), USP | 15.75 |
| Vitamin E, USP, d,l-£\-tocopoheryl acid succinate | 33.71 |
| Folic acid (powder), USP | 0.18 |
| Magnesium stearate | 5 |
| Microcrystalline cellulose 102 | 40 |
| Vitamin B12; use cyanocobalamine powder in gelatin (1000 £gg/g) | 4.2 |
Sulfadimidine Tablets (500 mg)
| Ingredients | mg/tab |
| Sulfadimidine | 500 |
| Lactose monohydrate | 100 |
| Povidone (K30) | 15 |
| Purified water | 200 |
| Crospovidone | 25 |
| Talc | 2.4 |
| Colloidal silicon dioxide | 0.3 |
| Calcium arachinate | 0.3 |
Fucidine Tablets (125 mg)
| Ingredients | mg/tab |
| Fucidine | 125 |
| Dicalcium phosphate (Di-Tab) | 63 |
| Povidone (90F) | 2.5 |
| Isopropyl alcohol | 30 mL |
| Crospovidone | 6.2 |
| Colloidal silicon dioxide | 1.3 |
| Magnesium stearate | 3 |
Metronidazole Tablets
| Ingredients | mg/tablet |
| Metronidazole | 400 |
| Lactose monohydrate | 150 |
| Cornstarch | 5.7 |
| Povidone (K30) | 3 |
| Cornstarch | 50 |
| Purified water | 121.00 mL |
| Cornstarch | 20 |
| Magnesium stearate | 1.25 |
(source: handbook of Pharmaceutical Manufacturing Formulations, Compressed Solid Products. Author: Sarfaraz K. Niazi)
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