Revision Bulletin

Official April 1, 2012 Sucrose 1

. Blank: Freshly prepared distilled water

Analysis: Determine the sulfite content by a suitable en-
Sucrose zymatic method based on the following reactions. Sul-
Portions of the monograph text that are national USP text, fite is oxidized by sulfite oxidase to sulfate and hydro-
and are not part of the harmonized text, are marked gen peroxide which in turn is reduced by
with symbols (✦✦) to specify this fact. nicotinamide–adenine dinucleotide–peroxidase in the
presence of reduced nicotinamide–adenine dinucleotide
(NADH). The amount of NADH oxidized is proportional
to the amount of sulfite. Separately introduce 2.0 mL
each of the Sample solution, Reference solution, and Blank
in 10-mm cuvettes, and add the reagents as described
in the kit instructions. Measure the absorbance at the
maximum at about 340 nm before and at the end of
the reaction time, and subtract the value obtained with
C12H22O11 342.30 the Blank.
α-D-Glucopyranoside, β-D-fructofuranosyl-sucrose [57-50-1]. Acceptance criteria: The absorbance difference of the
DEFINITION Sample solution is not greater than half the absorbance
Sucrose is a sugar obtained from Saccharum officinarum difference of the Reference solution.▲NF30
Linné (Fam. Gramineae), Beta vulgaris Linné (Fam. Che- SPECIFIC TESTS
nopodiaceae), and other sources. It contains no added
substances.
Add the following:
IMPURITIES
▲ • APPEARANCE OF SOLUTION
Delete the following: Sample solution: 500 mg/mL of Sucrose in water.
[NOTE—Set a portion of this solution aside for the tests
▲• RESIDUE ON IGNITION 〈281〉: NMT 0.05%, a 5-g speci- for Dextrins and Reducing Sugars.]
men being used▲NF30 Hydrazine sulfate solution: 10 mg/mL of hydrazine sul-
fate in water. Allow to stand for 4–6 h.
Hexamethylenetetramine solution: In a 100-mL
Delete the following: ground-glass-stoppered flask, dissolve 2.5 g of hex-
amethylenetetramine in 25.0 mL of water.
▲• CHLORIDE AND SULFATE, Chloride 〈221〉: A 2.0-g portion Primary opalescent suspension: To the Hex-
shows no more chloride than corresponds to 0.10 mL of amethylenetetramine solution in the flask add 25.0 mL of
0.020 N hydrochloric acid (35 ppm).▲NF30 Hydrazine sulfate solution. Mix, and allow to stand for 24
h. This suspension is stable for 2 months, provided it is
stored in a glass container free from surface defects. The
Delete the following: suspension must not adhere to the glass and must be
well mixed before use.
▲• CHLORIDE AND SULFATE, Sulfate 〈221〉: A 5.0-g portion Standard of opalescence: Primary opalescent suspension
shows no more sulfate than corresponds to 0.30 mL of in water (3 in 200). This suspension is freshly prepared
0.020 N sulfuric acid (60 ppm).▲NF30 and may be stored for up to 24 h.
Reference suspension I: Standard of opalescence and
Delete the following: water (5:95)
Acceptance criteria: The clarity of the Sample solution is
▲ • CALCIUM: To 10 mL of a solution (1 in 10) add 1 mL of the same as that of water or its opalescence is not more
ammonium oxalate TS: the solution remains clear for at pronounced than that of Reference suspension I.▲NF30
least 1 min.▲NF30
Add the following:
Delete the following: ▲ • CONDUCTIVITY
▲• HEAVY METALS 〈231〉: Dissolve 4.0 g in 15 mL of water, Sample solution: 313 mg/mL of Sucrose in freshly
add 1 mL of 0.12 N hydrochloric acid, and dilute with boiled and cooled water
water to 25 mL. Apparatus: Use a conductivity meter or resistivity meter
Acceptance criteria: NMT 5 ppm▲NF30 that measures the resistance of the column of liquid be-
tween the electrodes of the immersed measuring de-
vice. The apparatus is supplied with alternating current
Add the following: to avoid the effects of electrode polarization. It is
equipped with a temperature compensation device or a
▲ • SULFITE precision thermometer.
Sample solution: 400 mg/mL of Sucrose in freshly pre- Calibration: Choose a conductivity cell that is appropri-
pared distilled water ate for the conductivity of the solution to be examined.
Sulfite standard solution (80 ppm SO2): 0.1575 The higher the expected conductivity, the higher the
mg/mL of anhydrous sodium sulfite in freshly prepared cell constant that must be chosen so that the value
distilled water measured, R, is as large as possible for the apparatus
Reference solution: Dissolve 4.0 g of Sucrose in freshly used. Commonly used conductivity cells have cell con-
prepared distilled water, add 0.5 mL of Sulfite standard stants on the order of 0.1 cm−1, 1 cm−1, and 10 cm−1.
solution (80 ppm SO2), and dilute with freshly prepared Use a standard solution of potassium chloride that is
distilled water to 10.0 mL. appropriate for the measurement. Rinse the cell several
times with water that has been previously boiled and

2012 The United States Pharmacopeial Convention All Rights Reserved.

 Revision Bulletin
2 Sucrose Official April 1, 2012

cooled to room temperature and at least twice with the Acceptance criteria: NMT 45▲NF30
potassium chloride solution used for the determination
of the cell constant of the conductivity cell. Measure the
resistance of the conductivity cell using the potassium Add the following:
chloride solution at 20 ± 0.1°.
The constant, C (in cm−1), of the conductivity cell is
▲ • DEXTRINS
given by the expression: [NOTE—If intended for use in the preparation of large-
volume infusions, it complies with the test for Dextrins.]
C = RKCl × KKCl Sample solution: Prepare as directed in the test for
Appearance of Solution.
RKCl = measured resistance (MΩ) Analysis: To 2 mL of the Sample solution add 8 mL of
KKCl = conductivity of the standard solution of water, 0.05 mL of dilute hydrochloric acid (73 g/L of
potassium chloride used (µS · cm−1) HCl), and 0.05 mL of 0.05 M iodine.
The measured constant, C, of the conductivity cell must Acceptance criteria: The solution remains yellow.▲NF30
be within 5% of the given value.
Analysis Add the following:
Sample: Sample solution
Measure the conductivity of the Sample solution (C1),
while gently stirring with a magnetic stirrer, and that
▲ • REDUCING SUGARS
of the water used for preparing the Sample solution Sample solution: Prepare as directed in the test for
(C2). The readings must be stable within 1% over a Appearance of Solution.
period of 30 s. Analysis: To 5 mL of the Sample solution in a test tube
Calculate the conductivity of the Sample solution from about 150 mm long and 16 mm in diameter, add 5 mL
the expression: of water, 1.0 mL of 1 M sodium hydroxide, and 1.0 mL
of a 1-g/L solution of methylene blue. Mix and place in
Result = C1 − (0.35 × C2) a water bath. After exactly 2 min, take the tube out of
the bath, and examine the solution immediately.
C1 = conductivity of the Sample solution Acceptance criteria: The blue color does not disappear
C2 = conductivity of the water used for preparing completely, ignoring any blue color at the air/solution
the Sample solution interface.▲NF30
Acceptance criteria: NMT 35 µS · cm−1 at 20°▲NF30
Add the following:
Change to read:
▲ • LOSS ON DRYING 〈731〉: Dry 2.000 g at 105° for 3 h: it
• OPTICAL ROTATION, Specific Rotation 〈781S〉 loses NMT 0.1% of its weight.▲NF30
Sample solution: Previously dried Sucrose at 105° for 2
h. Prepare a solution of 260 mg/mL of Sucrose in water. Add the following:
Acceptance criteria: ▲+66.3 to +67.0▲NF30
▲ • BACTERIAL ENDOTOXINS 〈85〉: Less than 0.25 IU/mg
Add the following: [NOTE—If intended for use in the preparation of large-
volume infusions, it complies with the test for Bacterial
▲ • COLOR VALUE Endotoxins.]▲NF30
Sample solution: Dissolve 50.0 g in 50.0 mL of water.
Mix, filter (diameter of pores, 0.45 µm), and degas. Delete the following:
Analysis: Measure the absorbance at 420 nm, using a
cell of at least 4 cm (a cell length of 10 cm or more is ▲ • INVERT SUGAR
preferred). Sample solution: 200 mg/mL of Sucrose in water
Calculate the Color Value using the expression: [NOTE—Filter if necessary.]
Result = (A × 1000)/(b × c) Analysis: Place 50 mL of the clear liquid in a 250-mL
beaker, add 50 mL of alkaline cupric tartrate TS, cover
A = absorbance measured at 420 nm the beaker with a watch glass, and heat the mixture at
b = cell path length (cm) such a rate that it comes to a boil in approximately 4
c = concentration of the solution (g/mL), min, and boil for 2 min, accurately timed. Add at once
calculated from the refractive index of the 100 mL of cold, recently boiled water, and immediately
solution. Use Table 1, and interpolate the collect the precipitated cuprous oxide on a tared
values if necessary. The absolute difference filtering crucible containing a sintered-glass disk of
between two results is NMT 3. medium pore size, or suitable equivalent. Thoroughly
wash the residue on the filter with hot water, then with
10 mL of alcohol, and finally with 10 mL of ether, and
Table 1 dry at 105° for 1 h.
n20
D c (g/mL) Acceptance criteria: The weight of the cuprous oxide
1.4138 0.570 does not exceed 112 mg.▲NF30
1.4159 0.585
1.4179 0.600
1.4200 0.615
1.4221 0.630
1.4243 0.645
1.4264 0.661

2012 The United States Pharmacopeial Convention All Rights Reserved.

Revision Bulletin
Official April 1, 2012 Sucrose 3

ADDITIONAL REQUIREMENTS
• ✦PACKAGING AND STORAGE: Preserve in well-closed
containers.✦

Add the following:

▲• LABELING: The label states, where applicable, that the
substance is suitable for use in the manufacture of large-
volume parenteral dosage forms.▲NF30
•(Postponed indefinitely)•(RB 1-Apr-2012)

2012 The United States Pharmacopeial Convention All Rights Reserved.