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Read MoreTECHNICAL INFORMATION – MENDONYL™ POVIDONE (PVP)
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.
Pharmaceutical formulations using PVP:
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 |
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 |
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 |
Ingredients | mg/tab |
Chloroquine diphosphate | 250 |
Dicalcium phosphate (Ditab) | 100 |
Povidone (K30) | 10 |
Isopropyl alcohol | 83 |
Crospovidone | 10 |
Colloidal silicon dioxide | 2 |
Talc | 3 |
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 |
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 |
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 |
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)