Description


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)


