Dextrose Injection
DEFINITION
Dextrose Injection is a sterile solution of Dextrose in Water for Injection. It contains NLT 95.0% and NMT 105.0% of the labeled amount of dextrose (C6H12O6·H2O). Dextrose Injection contains no antimicrobial agents.
IDENTIFICATION
• A.
Sample solution:
Nominally 50 mg/mL of dextrose from a suitable volume of Injection in water
Analysis:
Add a few drops of the Sample solution to 5 mL of hot alkaline cupric tartrate TS.
Acceptance criteria:
A copious red precipitate of cuprous oxide is formed.
ASSAY
• Procedure
Sample solution:
Nominally 20–50 mg/mL of dextrose prepared as follows. Transfer a volume of Injection containing 2–5 g of dextrose to a 100-mL volumetric flask. Add 0.2 mL of 6 N ammonium hydroxide, and dilute with water to volume.
Determine the angular rotation in a suitable polarimeter tube (see Optical Rotation 
781
).
781).
Analysis:
Calculate the percentage of the labeled amount of dextrose (C6H12O6·H2O) in the portion of Injection taken:
Result = [(100 × a)/(l × 
)] × (1/CU) × (Mr1/Mr2) × 100
)] × (1/CU) × (Mr1/Mr2) × 100| a | = | = observed angular rotation of the Sample solution, in degrees |
| l | = | = length of the polarimeter tube, in decimeters |
| = | = midpoint of the specific rotation range for anhydrous dextrose, 52.9 |
| CU | = | = nominal concentration of dextrose in Sample solution, g/100 mL |
| Mr1 | = | = molecular weight of dextrose monohydrate, 198.17 |
| Mr2 | = | = molecular weight of anhydrous dextrose, 180.16 |
Acceptance criteria:
95.0%–105.0%
IMPURITIES
• Limit of 5-Hydroxymethylfurfural and Related Substances
Sample solution:
Nominally 4 mg/mL of dextrose (C6H12O6·H2O) from a volume of Injection equivalent to 1.0 g of dextrose in water
Instrumental conditions
Mode:
UV
Analytical wavelength:
284 nm
Cell:
1 cm
Blank:
Water
Analysis
Samples:
Sample solution and Blank
Acceptance criteria:
The absorbance of the Sample solution is NMT 0.25.
SPECIFIC TESTS
• pH 791
791
Sample solution:
Dilute a suitable volume of Injection, if necessary, with water to NMT 5% of dextrose.
Analysis:
Add 0.30 mL of saturated potassium chloride to 100 mL of Sample solution, and measure the pH.
Acceptance criteria:
3.2–6.5
• Particulate Matter in Injections 788:
Meets the requirements
788:
Meets the requirements
• Bacterial Endotoxins Test 85
85
[Note—Before analysis, dilute Injections containing more than 10% of dextrose to a concentration of 10% of dextrose. ]
Acceptance criteria:
NMT 0.5 USP Endotoxin Unit/mL for Injection containing less than 5% dextrose; NMT 10.0 USP Endotoxin Units/g for Injection containing 5%–70% dextrose
• Other Requirements:
It meets the requirements in Injections 1.
1.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in single-dose glass or plastic containers. Glass containers are preferably of Type I or Type II glass. Store at room temperature.
• Labeling:
The label states the total osmolar concentration in mOsmol/L. Where the contents are less than 100 mL, or where the label states that the Injection is not for direct injection but is to be diluted before use, the label alternatively may state the total osmolar concentration in mOsmol/mL.
• USP Reference Standards 11
11
USP Endotoxin RS
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Domenick Vicchio, Ph.D.
Director - Chemical Medicines (301) 998-6828 |
(SM42010) Monographs - Small Molecules 4 |
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison (301) 816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP38–NF33 Page 3065
Pharmacopeial Forum: Volume No. 39(4)