JRS PHARMA EMDEX® Non-GMO - Dextrates Hydrated NF
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EMDEX® Non-GMO is a corn-derived, non-GMO directly compressible excipient based on Dextrates Hydrated NF. It is used in pharmaceutical solid dosage forms where good flow, compressibility, and pleasant mouthfeel are required.
Non-GMO, corn-derived dextrates hydrated excipient.- Supports good powder flow and tablet compressibility.
- Suitable for tablets, chewables, lozenges, granules, and powder blends.
- Provides a mildly sweet taste and pleasant mouthfeel.
- Supporting declarations cover GMO, animal-origin, BSE/TSE, gluten, and regulatory status.
Shows the material composition, raw material origin, and excipient use of EMDEX® Non-GMO.
Composition and Material Identity
EMDEX® Non-GMO is composed of corn-derived dextrates hydrated NF. It is a carbohydrate-based excipient produced from non-GMO raw material and designed for direct compression applications.
Technical specifications table showing chemical and physical specification parameters with acceptance criteria and reference methods.
| Technical Specifications | ||
|---|---|---|
| Parameter | Acceptance criteria | Reference |
| Dextrose equivalent | 93.0% - 99.0% | NF |
| Heavy metals | Max. 5 ppm | JRS Pharma Method |
| Loss on drying | 7.8 – 9.2% | USP |
| pH | 3.8 – 5.8 | USP |
| Residual solvents | Meets the requirement | USP |
| Residue on ignition | Max. 0.1% | USP |
| Sulfur dioxide | Max. 10 ppm | USP |
| TAMC (Total Aerobic Microbial Count) | 10³ cfu/g | USP |
| Escherichia coli | Absent in 1 g | USP |
| Salmonella species | Absent in 10 g | USP |
| Particle Size (Ro-Tap®) | JRS Pharma Method | |
| > 850 µm (20 mesh) | Max. 3.0 % | JRS Pharma Method |
| < 150 um (100 mesh) | Max. 25.0 % | JRS Pharma Method |
| Tapped density | 0.68 – 0.83 g/mL | JRS Pharma Method |
Regulatory compliance table showing regulations, compliance status, scope, and supporting notes for EMDEX® Non-GMO.
| Regulatory Compliance | ||
|---|---|---|
| Regulation | Status | Notes |
| European Food Law | Complies | Product is periodically tested for aflatoxins, with results consistently below 0.1 µg/kg. |
| EMA/410/01 | Complies | Product is not made from and does not contact products of human or animal origin. |
| ICH M7 | Not in scope | No known or potential genotoxic impurities have been identified. |
| GRAS | Considered GRAS | Product is considered Generally Recognized as Safe by the US FDA. |
| NF | Complies | Dextrates monograph is included in the current edition of NF. |
Practical product information covering use, storage, suitability, and declarations.
How should this product be stored?
Store in original, unopened, well-closed containers and protect from excessive heat and moisture.
What applications is EMDEX® Non-GMO suitable for?
It is suitable for tablets, chewables, lozenges, granules, and powder blends where direct compression, flow, and mouthfeel are important.
What is the recommended re-evaluation period?
When stored as recommended, the recommended re-evaluation period is 3 years from the date of manufacture.
Is EMDEX® Non-GMO suitable for vegan or vegetarian products?
It is suitable for vegans and ovo-lacto-vegetarians.
Nutritional profile table showing nutrient names with minimum or maximum values and units.
| Nutritional Profile | |||||
|---|---|---|---|---|---|
| EU Regulation | |||||
| Nutrient | Values per 100 g | ||||
| Calorific value | 381 kcal or 1594 kJ/100 g*3 | ||||
| Protein | <0.781 g | ||||
| Usable carbohydrate*2 | 94.3 g | ||||
| Sucrose | < 0.1 g | ||||
| Glucose | 93.7 g | ||||
| Fructose | <0.1 g | ||||
| Fat | 0.01 g | ||||
| Saturated fatty acids | 0.01 g | ||||
| Unsaturated fatty acids | 0.0 g | ||||
| Dietary fiber*4 | 1.4 g | ||||
| Sodium | < 0.003 g | ||||
| *2 Calculated | |||||
| *3 Within the European Union due to directive 2008/100/EC dietary fibers have to be calculated with 2 kcal/g - 8 kJ/g. From 31 October 2012 no trade is allowed with products which do not comply with this directive. | |||||
| *4 The dietary fiber content in the dried matter is min 1.4%. | |||||
| US Regulation | |||||
| Nutrient | Avg. Units per 100 g | ||||
| Carbohydrates | 91.2% | ||||
| Carbohydrates, Available | 90.2% | ||||
| Calories | 365 calories/100 g | ||||
| Calories from Fat | 0 calories/100 g | ||||
| Calories from Saturated Fat | 0 calories/100 g | ||||
| Calories (Insoluble Fiber Subtracted) | 361 calories/100 g | ||||
| Calcium | <1.00 mg/100 g | ||||
| Iron | <1.00 mg/100 g | ||||
| Potassium | <3.00 mg/100 g | ||||
| Ash | <3.00 mg/100 g | ||||
| Moisture | 8.761% | ||||
| Total Fat | 0.01% | ||||
| Saturated Fat | 0.01% | ||||
| Monounsaturated Fat | 0.00% | ||||
| cis-cis Polyunsaturated Fat | 0.00% | ||||
| trans Fat | 0.00% | ||||
| Protein | <0.781% | ||||
| Insoluble Fiber | 1.0% | ||||
| Soluble Fiber | 0.4% | ||||
| Total Fiber | 1.4% | ||||
| Fructose | Less than 0.1% | ||||
| Glucose | 93.7% | ||||
| Sucrose | Less than 0.1% | ||||
| Maltose | 0.167% | ||||
| Total Sugars | 93.9% | ||||
Storage conditions, re-evaluation timing, and basic powder-handling guidance.
Safety & Storage
- Store in original, unopened, well-closed containers.
- Protect from excessive heat and moisture.
- Seal bags and secure drums tightly when the full package is not used.
- Recommended re-evaluation period is 3 years from the date of manufacture when stored as recommended.
- Avoid unnecessary dust formation during handling.
Allergen information table showing allergen names and absence status for EMDEX® Non-GMO.
| Allergen Information | |
|---|---|
| Allergen | Status |
| Cereals containing gluten (i.e. wheat, rye, barley, oats, spelt, kamut or their hybridised strains) and products thereof | Absent |
| Crustaceans and products thereof | Absent |
| Eggs and products thereof | Absent |
| Fish and products thereof | Absent |
| Peanuts and products thereof | Absent |
| Soybeans and products thereof | Absent |
| Milk and products thereof (including lactose) | Absent |
| Nuts i.e. Almond (Amygdalus communis), Hazelnut (Corylus avellana), Walnut (Juglans regia), Cashew (Anacardium occidentale), Pecan nut (Carya illinoiesis), Brazil nut (Bertholletia excelsa), Pistachio nut (Pistacia vera), Macadamia nut and Queensland nut (Macadamia ternifolia) and products thereof | Absent |
| Celery and products thereof | Absent |
| Mustard and products thereof | Absent |
| Sesame seeds and products thereof | Absent |
| Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre expressed as SO2 | Absent |
| Lupines and products thereof | Absent |
| Peanuts | Absent |
| Mustard | Absent |
| Pork | Absent |
| Peanut oil | Absent |
| Molluscs | Absent |