NF 30Official Monographs / Sucrose 1995
tinamide–adenine dinucleotide (NADH). The amount of
NADH oxidized is proportional to the amount of sulfite. Sep-Sucrose
arately introduce 2.0 mL each of the Sample solution , Refer-Portions of the monograph text that are national USP  text, and ence solution , and Blank  in 10-mm cuvettes, and add the are not part of the harmonized text, are marked with symbols reagents as described in the kit instructions. Measure the (33) to specify this fact.
absorbance at the maximum at about 340 nm before and at the end of the reaction time, and subtract the value ob-tained with the Blank .
Acceptance criteria: The absorbance difference of the Sam-ple solution  is not greater than half the absorbance differ-
ence of the Reference solution .v NF30
SPECIFIC TESTS C 12H 22O 11342.30α-D -Glucopyranoside, β-D -fructofuranosyl-sucrose [57-50-1].Add the following:
DEFINITION
v
•A PPEARANCE  OF  S OLUTION
Sucrose is a sugar obtained from Saccharum officinarum  Linn´e Sample solution: 500 mg/mL of Sucrose in water. [N OTE —(Fam. Gramineae), Beta vulgaris  Linn´e  (Fam. Cheno-Set a portion of this solution aside for the tests for Dextrins podiaceae), and other sources. It contains no added and Reducing Sugars .]
substances.Hydrazine sulfate solution: 10 mg/mL of hydrazine sulfate in water. Allow to stand for 4–6 h.
IMPURITIES
Hexamethylenetetramine solution: In a 100-mL ground-glass-stoppered flask, dissolve 2.5 g of hexamethylenete-Delete the following:
tramine in 25.0 mL of water.
Primary opalescent suspension: To the Hexamethylenete-tramine solution  in the flask add 25.0 mL of Hydrazine sulfate v
•R ESIDUE  ON  I GNITION  〈281〉: NMT 0.05%, a 5-g specimen solution . Mix, and allow to stand for 24 h. This suspension is being used v NF30
stable for 2 months, provided it is stored in a glass container free from surface defects. The suspension must not adhere Delete the following:
to the glass and must be well mixed before use.
Standard of opalescence: Primary opalescent suspension  in v
•C HLORIDE  AND  S ULFATE , Chloride  〈221〉: A 2.0-g portion
water (3 in 200). This suspension is freshly prepared and shows no more chloride than corresponds to 0.10 mL of 0.020may be stored for up to 24 h.
N hydrochloric acid (35 ppm).v NF30
Reference suspension I: Standard of opalescence  and water (5:95)
Acceptance criteria: The clarity of the Sample solution  is the Delete the following:
same as that of water or its opalescence is not more pro-nounced than that of Reference suspension I .v NF30
v
•C HLORIDE  AND  S ULFATE , Sulfate 〈221〉: A 5.0-g portion shows no more sulfate than corresponds to 0.30 mL of 0.020 N sulfu-ric acid (60 ppm).v NF30
Add the following:
v
•C ONDUCTIVITY
Delete the following:
Sample solution: 313 mg/mL of Sucrose in freshly boiled and cooled water
v
•C ALCIUM : To 10 mL of a solution (1 in 10) add 1 mL of Apparatus: Use a conductivity meter or resisti
vity meter that ammonium oxalate TS: the solution remains clear for at least 1measures the resistance of the column of liquid between the min.v NF30
electrodes of the immersed measuring device. The apparatus is supplied with alternating current to avoid the effects of Delete the following:
electrode polarization. It is equipped with a temperature compensation device or a precision thermometer.
Calibration: Choose a conductivity cell that is appropriate v
•H EAVY  M ETALS  〈231〉: Dissolve 4.0 g in 15 mL of water, add for the conductivity of the solution to be examined. The 1 mL of 0.12 N hydrochloric acid, and dilute with water to 25higher the expected conductivity, the higher the cell con-mL.
stant that must be chosen so that the value measured, R , is Acceptance criteria: NMT 5 ppm v NF30
as large as possible for the apparatus used. Commonly used conductivity cells have cell constants on the order of 0.1Add the following:
cm −1, 1 cm −1, and 10 cm −1. Use a standard solution of potas-sium chloride that is appropriate for the measurement. Rinse v
•S ULFITE
the cell several times with water that has been previously Sample solution: 400 mg/mL of Sucrose in freshly prepared boiled and cooled to room temperature and at least twice distilled water
with the potassium chloride solution used for the determina-Sulfite standard solution (80 ppm SO 2): 0.1575 mg/mL of tion of the cell constant of the conductivity cell. Measure anhydrous sodium sulfite in freshly prepared distilled water the resistance of the conductivity cell using the potassium Reference solution: Dissolve 4.0 g of Sucrose in freshly pre-chloride solution at 20±0.1°.
pared distilled water, add 0.5 mL of Sulfite standard solution The constant, C  (in cm −1), of the conductivity cell is given by (80 ppm SO 2), and dilute with freshly prepared distilled the expression:
water to 10.0 mL.
Blank: Freshly prepared distilled water
C  = R KCl  × K KCl
Analysis: Determine the sulfite content by a suitable enzy-matic method based on the following reactions. Sulfite is R KCl = measured resistance (M Ω)
oxidized by sulfite oxidase to sulfate and hydrogen peroxide K KCl
= conductivity of the standard solution of
which in turn is reduced by nicotinamide–adenine dinucleo-potassium chloride used (µS ·cm −1)
tide–peroxidase in the presence of reduced nico-
1996Sucrose  / Official Monographs
NF 30
The measured constant, C , of the conductivity cell must be Acceptance criteria: The solution remains yellow.v NF30within 5% of the given value.Analysis
Add the following:
Sample: Sample solution
Measure the conductivity of the Sample solution  (C 1), while v
•R EDUCING  S UGARS
gently stirring with a magnetic stirrer, and that of the Sample solution: Prepare as directed in the test for water used for preparing the Sample solution  (C 2). The Appearance of Solution .
readings must be stable within 1% over a period of 30 s.Analysis: To 5 mL of the Sample solution  in a test tube,Calculate the conductivity of the Sample solution  from the about 150 mm long and 16 mm in diameter, add 5 mL of expression:
water, 1.0 mL of 1M sodium hydroxide, and 1.0 mL of a 1-g/L solution of methylene blue. Mix and place in a water Result = C 1 − (0.35 × C 2)
bath. After exactly 2 min, take the tube out of the bath, and examine the solution immediately.
C 1= conductivity of the Sample solution Acceptance criteria: The blue color does not disappear C 2= water used for preparing the Sample solution completely, ignoring any blue color at the air/solution Acceptance criteria: NMT 35 µS ·cm −1 at 20°v NF30interface.v NF30
Change to read:
Add the following:
•O PTICAL  R OTATION , Specific Rotation  〈781S 〉
v
•L OSS  ON  D RYING  〈731〉: Dry 2.000 g at 105° for 3 h: it loses Sample solution: Previously dried Sucrose at 105° for 2 h.NMT 0.1% of its weight.v NF30
Prepare a solution of 260 mg/mL of Sucrose in water.Acceptance criteria: v +66.3 to +67.0v NF30Add the following:
Add the following:
v
•B ACTERIAL  E NDOTOXINS  〈85〉: Less than 0.25 IU/mg [N OTE —If intended for use in the preparation of large-v
•C OLOR  V ALUE
volume infusions, it complies with the test for Bacterial Sample solution: Dissolve 50.0 g in 50.0 mL of water. Mix,Endotoxins .]v NF30
filter (diameter of pores, 0.45 µm), and degas.
Analysis: Measure the absorbance at 420 nm, using a cell of at least 4 cm (a cell length of 10 cm or more is preferred).Delete the following:
Calculate the Color Value  using the expression:
v
•I NVERT  S UGAR
Result = (A  × 1000)/(b  × c )
Sample solution: 200 mg/mL of Sucrose in water [N OTE —Filter if necessary.]
A = absorbance measured at 420 nm Analysis: Place 50 mL of the clear liquid in a 250-mL
b = cell path length (cm)
beaker, add 50 mL of alkaline cupric tartrate TS, cover the c
= concentration of the solution (g/mL), calculated
beaker with a watch glass, and heat the mixture at such a from the refractive index of the solution. Use rate that it comes to a boil in approximately 4 min, and boil Table 1, and interpolate the values if necessary.for 2 min, accurately timed. Add at once 100 mL of cold,The absolute difference between two results is recently boiled water, and immediately collect the NMT 3.
precipitated cuprous oxide on a tared filtering crucible containing a sintered-glass disk of medium pore size, or Table 1
suitable equivalent. Thoroughly wash the residue on the n 20D c  (g/mL)filter with hot water, then with 10 mL of alcohol, and finally with 10 mL of ether, and dry at 105° for 1 h.
1.41380.570Acceptance criteria: The weight of the cuprous oxide does 1.41590.585not exceed 112 mg.v NF30
1.41790.6001.42000.615ADDITIONAL REQUIREMENTS
•3P ACKAGING  AND  S TORAGE : Preserve in well-closed 1.42210.630containers.31.42430.6451.4264
0.661
Add the following:
Acceptance criteria: NMT 45v NF30v
•L ABELING : The label states, where applicable, that the
substance is suitable for use in the manufacture of large-volume Add the following:
parenteral dosage forms.v NF30delete in
v
•D EXTRINS
[N OTE —If intended for use in the preparation of large-volume infusions, it complies with the test for Dextrins .]Sample solution: Prepare as directed in the test for Sucrose Octaacetate
Appearance of Solution .
Analysis: To 2 mL of the Sample solution  add 8 mL of water,0.05 mL of dilute hydrochloric acid (73g/L of HCl), and 0.05 mL of 0.05 M iodine.
C 28H 38O 19678.59

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