FSSAI-Schedule VF -List of food additives to be used in formats such as tablets, capsules and syrups
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FSSAI-Schedule VF -List of food additives to be used in formats such as tablets, capsules and syrups
Covers regulations 3.(1), 3.(13), 6.(4), 7.(5), 8.(4), 9.(4), 10.(3), 11.(3) and 12.(4)]
List of Food Additives for Tablets, Capsules, and Syrups
| S. No. | Additive (Pharmaceutical Aid) | Functionality | Maximum Permitted Level |
|---|---|---|---|
| 1 | Acacia gum | Binding agent | GMP |
| 2 | Acetone | Solvent for coating | GMP (does not remain in the tablet and residual levels to be as per IP) |
| 3 | Ascorbic acid and its esters and salts | Antioxidant | 0.5% |
| 4 | Benzoic acid and its salts | Preservative | 0.5% |
| 5 | BHA | Antioxidant | 0.5% |
| 6 | BHT | Antioxidant | 0.5% |
| 7 | Bronopol | Preservative | 0.5% |
| 8 | Calcium carbonate | Diluent, Disintegrant | GMP |
| 9 | Calcium stearate | Lubricant | 1% |
| 10 | Carboxymethylcellulose Calcium | Binding agent | 5-15% |
| 11 | Carrageenan gum | Binding agent | 2% |
| 12 | Cellulose acetate phthalate | Coating agent | 2% |
| 13 | Citric acid | Disintegrant | 2% |
| 14 | Citric and fatty acid esters of glycerol | Stabilizer | 2% |
| 15 | Copovidone | Binding agent | 2-5% |
| 16 | Corn oil | Vehicle | GMP |
| 17 | Corn starch | Diluent, Binding agent, Disintegrant | GMP |
| 18 | Cross carmellose sodium | Disintegrant | 2% |
| 19 | Cyclodextrin | Diluent | GMP |
| 20 | Dextrose | Diluent | GMP |
| 21 | Dicalcium phosphate | Diluent | GMP |
| 22 | Ethyl acetate | Solvent for coating | GMP (does not remain in the tablet and residual levels to be as per IP) |
| 23 | Ethyl alcohol | Solvent for coating | GMP (does not remain in the tablet and residual levels to be as per IP) |
| 24 | Ethyl cellulose | Coating agent, Ingredient of capsule shells | GMP |
| 25 | Fructose | Diluent | GMP |
| 26 | Gelatin | Binding agent, Ingredient of capsule shells | GMP |
| 27 | Glycerin | Vehicle, Humectant for capsule shells | GMP |
| 28 | Guar gum | Binding agent | GMP |
| 29 | Hydrogenated castor oil | Lubricant | 2% |
| 30 | Hydrogenated vegetable oil | Lubricant | 1% |
| 31 | Hydroxy propyl methylcellulose | Coating agent, Ingredient of capsule shells | GMP |
| 32 | Isomalt | Soluble fiber | 15% |
| 33 | Kaolin | Diluent | GMP |
| 34 | Lactitol | Diluent | 200 mg per capsule |
| 35 | Lactose | Diluent | GMP |
| 36 | Lecithin and its salts/esters from soya | Emulsifier, Stabilizer | GMP |
| 37 | Light magnesium carbonate | Anticaking agent | 0.5% |
| 38 | Light magnesium oxide | Anticaking agent | 0.5% |
| 39 | Liquid glucose | Binding agent | GMP |
| 40 | Magnesium carbonate | Adsorbent | 0.3% |
| 41 | Magnesium stearate | Antisticking agent, Glidant | 2% |
| 42 | Maize Starch | Diluent, Binding agent, Disintegrant | GMP |
| 43 | Maltitol | Sweetener, Diluent | GMP |
| 44 | Maltodextrin | Diluent | GMP |
| 45 | Maltose | Diluent | GMP |
| 46 | Manitol | Diluent, Sweetener | GMP |
| 47 | Methyl paraben and its salts | Preservative | 0.2% |
| 48 | Microcrystalline cellulose | Diluent | GMP |
| 49 | Natural and synthetic colors as per FSSR | Coloring agents | Limits as per FSSR |
| 50 | Peanut oil | Vehicle | GMP |
| 51 | Pectin | Binding agent | GMP |
| 52 | PEG 4000 | Diluent for direct compression tablets | GMP |
| 53 | Colors permitted under Rule 127 of Drugs & Cosmetics Rules including lake colors | Coloring agents | GMP |
| 54 | Polyethylene glycol (PEG) | Vehicle, Humectant for capsule shells | GMP |
| 55 | Povidone | Binding agent | 5% |
| 56 | Propyl paraben and its salts | Preservative | 0.02% |
| 57 | Propylene glycol | Vehicle, Humectant for capsule shells | GMP |
| 58 | Purified Talc | Glidant, Dusting powder for coating | 2% |
| 59 | Safflower oil | Vehicle | GMP |
| 60 | Sodium alginate | Binding agent | 5% |
| 61 | Sodium starch glycolate | Disintegrant, Binder, Thickening agent | 2% |
| 62 | Sorbitan crystalline | Diluent | 15% |
| 63 | Sorbitan oleate esters (Tweens) | Solubilizers | 0.5% |
| 64 | Sorbitol liquid | Vehicle, Humectant for capsule shells | GMP |
| 65 | Starch, pregelatinized | Disintegrant | 1% |
| 66 | Stearic acid | Antisticking agent, Glidant | 2% |
| 67 | Sucrose | Diluent, Coating agent | GMP |
| 68 | Sunflower oil | Vehicle | GMP |
| 69 | TBHQ | Antioxidant | 0.5% |
| 70 | Tocoferol and its esters | Antioxidant | 0.5% |
| 71 | Tragacanth gum | Binding agent | GMP |
| 72 | Tribasic calcium phosphate | Diluent, anticaking agent | GMP |
| 73 | Tricalcium phosphate | Diluent | GMP |
| 74 | Vegetable oils | Vehicle | GMP |
| 75 | Xanthan gum | Binding agent | GMP |
| 76 | Xylitol | Diluent, Sweetener | GMP |
| 77 | Zinc stearate | Lubricant | 0.5-1.5% |
