Dextrose

Basic Information

Name: Dextrose

CAS No: D-(þ)-Glucose monohydrate [5996-10-1] See also Section 17.

Functional Categories

Sweetening agent Tablet and capsule diluent Therapeutic agent Tonicity agent

1. Nonproprietary Names

BP: Glucose JP: Glucose PhEur: Glucose Monohydrate USP: Dextrose

2. Synonyms

Blood sugar; Caridex; corn sugar; C*PharmDex; Dextrofin; D-(þ)- glucopyranose monohydrate; glucosum monohydricum; grape sugar; Lycadex PF; Roferose; starch sugar; Tabfine D-100

3. Chemical Name & CAS Registry

D-(þ)-Glucose monohydrate [5996-10-1] See also Section 17.

4. Empirical Formula & Molecular Weight

C6H12O6H2O 198.17 (for monohydrate) See also Section 17.

5. Structural Formula

Anhydrous material shown.

6. Applications

Dextrose is widely used in solutions to adjust tonicity and as a sweetening agent. Dextrose is also used as a wet granulation diluent and binder, and as a direct-compression tablet diluent and binder,primarily in chewable tablets. Although dextrose is comparable as a tablet diluent to lactose, tablets produced with dextrose monohydrate require more lubrication, are less friable, and have a tendency to harden.(1–3) The mildly reducing properties of dextrose may be used when tableting to improve the stability of active materials that are sensitive to oxidation. Dextrose is also used therapeutically and is the preferred source of carbohydrate in parenteral nutrition regimens.

7. Description

Dextrose occurs as odorless, sweet-tasting, colorless crystals or as a white crystalline or granular powder. The JP XV describes dextrose as dextrose anhydrous; the PhEur 6.3 specifies dextrose as either dextrose anhydrous or dextrose monohydrate; and the USP 32 specifies dextrose as dextrose monohydrate

8. Pharmacopeial Specifications

9. Typical Properties

See Table I. See also Sections 17 and 18.

10. Stability & Storage

Data are shown for dextrose monohydrate; see Section 17 for data for dextrose anhydrous. Acidity/alkalinity pH = 3.5–5.5 (20% w/v aqueous solution) Density (bulk) 0.826 g/cm3 Density (tapped) 1.020 g/cm3 Density (true) 1.54 g/cm3 Heat of solution 105.4 J/g (25.2 cal/g) Melting point 838C Moisture content Dextrose anhydrous absorbs significant amounts of moisture at 258C and a relative humidity of about 85% to form the monohydrate. The monohydrate similarly only absorbs moisture at around 85% relative humidity and 258C. See Figure 1. NIR spectra see Figure 2. Osmolarity A 5.51% w/v aqueous solution is isoosmotic with serum. However, it is not isotonic since dextrose can pass through the membrane of red cells and cause hemolysis. Solubility see Table II.

11. Incompatibilities

Dextrose has good stability under dry storage conditions. Aqueous solutions may be sterilized by autoclaving. However, excessive heating can cause a reduction in pH and caramelization of solutions.(4–7) The bulk material should be stored in a well-closed container in a cool, dry place.

12. Method of Manufacture

Dextrose solutions are incompatible with a number of drugs such as cyanocobalamin, kanamycin sulfate, novobiocin sodium, and warfarin sodium.(8) Erythromycin gluceptate is unstable in dextrose solutions at a pH less than 5.05.(9) Decomposition of B-complex vitamins may occur if they are warmed with dextrose. In the aldehyde form, dextrose can react with amines, amides, amino acids, peptides, and proteins. Brown coloration and decomposition occur with strong alkalis. Dextrose may cause browning of tablets containing amines (Maillard reaction).

13. Safety

Dextrose, a monosaccharide sugar, occurs widely in plants and is manufactured on a large scale by the acid or enzymatic hydrolysis of starch, usually maize (corn) starch. Below 508C a-D-dextrose monohydrate is the stable crystalline form produced; above 508C the anhydrous form is obtained; and at still higher temperatures bD-dextrose is formed, which has a melting point of 148–1558C.

14. Handling Precautions

Dextrose is rapidly absorbed from the gastrointestinal tract. It is metabolized to carbon dioxide and water with the release of energy. Concentrated dextrose solutions given by mouth may cause nausea and vomiting. Dextrose solutions of concentration greater than 5% w/v are hyperosmotic and are liable to cause local vein irritation following intravenous administration. Thrombophlebitis has been observed following the intravenous infusion of isoosmotic dextrose solution with low pH, probably owing to the presence of degradation products formed by overheating during sterilization. The incidence of phlebitis may be reduced by adding sufficient sodium bicarbonate to raise the pH of the infusion above pH 7. LD50 (mouse, IV): 9 g/kg(10) LD50 (rat, oral): 25.8 g/kg

15. Regulatory Status

Observe normal precautions appropriate to the circumstances and quantity of material handled. Eye protection and gloves are recommended. Dust generation should be minimized to reduce the risk of explosion.

16. Related Substances

Included in the FDA Inactive Ingredients Database (capsules; inhalations; IM, IV, and SC injections; tablets, oral solutions, and syrups). Included in nonparenteral and parenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.

17. Comments

Dextrates; dextrin; dextrose anhydrous; fructose; glucose liquid; polydextrose; sucrose. Dextrose anhydrous Empirical formula C6H12O6 Molecular weight 180.16 CAS number [50-99-7] Synonyms anhydrous dextrose; anhydrous D-(þ)-glucopyranose; anhydrous glucose; dextrosum anhydricum. Appearance White, odorless, crystalline powder with a sweet taste. Acidity/alkalinity pH = 5.9 (10% w/v aqueous solution) Density (bulk) 1.3–1.4 g/cm3 Density (tapped) 1.1–1.2 g/cm3 Melting point 1468C Moisture content see Section 10. NIR spectra see Figure 3. Osmolarity A 5.05% w/v aqueous solution is isoosmotic with serum. See also Section 10. Refractive index n D 20 = 1.3479 (10% w/v aqueous solution) Solubility see Table III.