Accessed from 10.6.1.
1 by merck1 on Fri Jun 03 05:36:42 EDT 2016
6394 Witch / Official Monographs
Witch Hazel
.
» Witch Hazel is a clear, colorless distillate pre-
pared from recently cut and partially dried dor-
mant twigs of Hamamelis virginiana Linné.
Prepare Witch Hazel as follows. Macerate a
weighed amount of the twigs for about 24 hours
in about twice their weight of water, then distill
until not less than 800 mL and not more than
850 mL of clear, colorless distillate is obtained
from each 1000 g of the twigs taken. Add
150 mL of Alcohol to each 850 mL of distillate,
and mix thoroughly.
Packaging and storage—Preserve in tight containers, and
avoid exposure to excessive heat.
Specific gravity 〈841〉: between 0.979 and 0.983.
pH 〈791〉: between 3.0 and 5.0.
Nonvolatile residue—Evaporate 100 mL to dryness in a
tared dish on a hot plate at 60°: the weight of the residue
does not exceed 25 mg (0.025%).
Change to read:
Limit of tannins—
Mobile phase A—Adjust 1000 mL of water with phos-
phoric acid to a pH of 2.5 ± 0.1. Filter and degas.
USP Monographs
Official from May 1, 2016
Copyright (c) 2016 The United States Pharmacopeial Convention. All rights reserved.
USP 39
Mobile phase B—Use filtered and degassed acetonitrile.
Standard solution—Dissolve an accurately weighed quan-
tity of tannic acid in water to obtain a solution having a
known concentration of about 0.03 mg of tannic acid per
mL.
Test solution—Use Witch Hazel.
Chromatographic system (see Chromatography 〈621〉)—The
liquid chromatograph is equipped with a 280-nm detector
and a •4.6-mm × 15-cm• (ERR 1-Apr-2015) column that contains
.
packing L1 and is programmed to provide variable mixtures
of Mobile phase A and Mobile phase B. Initially, the system is
held at a mixture consisting of 90% Mobile phase A and
10% Mobile phase B for 5.0 minutes. The proportion of Sol-
vent B to Solvent A is increased linearly to 100% over the
next 15 minutes. The flow rate is about 1 mL per minute.
Procedure—Separately inject equal volumes (about 25 µL)
of the Standard solution and the Test solution into the chro-
matograph, record the chromatograms, and measure the re-
sponses for all peaks. If any peak corresponding to the re-
tention time of tannic acid in the Standard solution is
present in the chromatogram of the Test solution, its peak
area is no more than that of the tannic acid in the Standard
solution.
Change to read:
•Alcohol Determination, Method I 〈611〉• (CN 1-May-2016):
.
between 14.0% and 15.0% of C2H5OH.
Accessed from 10.6.1.1 by merck1 on Fri Jun 03 05:36:42 EDT 2016
USP 39
Xenon Xe 127
.
» Xenon Xe 127 is a gas suitable for inhalation in
diagnostic studies. Xenon 127 is a radioactive nu-
clide that may be prepared from the bombard-
ment of a cesium 133 target with high-energy
protons. It contains not less than 85.0 percent
and not more than 115.0 percent of the labeled
amount of 127Xe at the calibration date indicated
.
on the labeling.
Packaging and storage—Preserve in single-dose vials
having leak-proof stoppers, at room temperature. The vials
are enclosed in appropriate lead radiation shields. The vial
content may be diluted with air and is packaged at atmos-
pheric pressure.
Labeling—Label it to include the following: the name of
the preparation; the container volume, MBq (mCi) of 127Xe .
per container; the amount of 127Xe expressed as megabec-
.
querels (millicuries) per mL; the intended route of adminis-
tration; recommended storage conditions; the date of cali-
bration; the expiration date; the name, address, and batch
number of the manufacturer; the statement “Caution—Radi-
oactive Material”; and a radioactive symbol. The labeling
contains a statement of radionuclide purity, identifies proba-
ble radionuclidic impurities, and indicates permissible quan-
tities of each impurity. The labeling indicates that in making
dosage calculations, correction is to be made for radioactive
decay, and also indicates that the radioactive half-life of 127
.
Xe is 36.41 days.
Radionuclide identification (see Radioactivity 〈821〉)—Its
gamma-ray spectrum is identical to that of a known speci-
men of xenon 127 that exhibits major photopeaks at 202.8
keV, and 172.1 keV, and 375.0 keV. Minor photopeaks from
other xenon radioisotopes, namely Xe 129m (197 keV) and
Xe 131m (164 keV) may also be present.
Radionuclidic purity—Using a suitable counting assembly
(see Selection of a Counting Assembly under Radioactivity
〈821〉), determine the radioactivity of the Xe 127 in the gas
by use of a calibrated system as directed under Radioactivity
〈821〉. Using the gamma-ray spectrum, determine the en-
ergy of each gamma photopeak. Identify each radionuclide
present, and using the established detector efficiency and
known gamma abundance, calculate the quantity of each
radionuclide present in the specimen in MBq (mCi). The
amount of Xe 127 present in the specimen is not less than
80%; the quantity of either Xe 131m or Xe 129m does not
exceed 10%, and no other radioisotope exceeds 1%.
Assay for radioactivity—Using a suitable counting assem-
bly (see Selection of a Counting Assembly under Radioactivity
〈821〉), determine the radioactivity, in MBq (mCi), of Xe 127
in each container by use of a calibrated system as directed
under Radioactivity 〈821〉.
Xenon Xe 133
.
Xenon, isotope of mass 133.
Xenon, isotope of mass 133 [14932-42-4].
» Xenon Xe 133 is a gas suitable for inhalation in
diagnostic studies. Xenon 133 is a radioactive nu-
clide that may be prepared from the fission of
uranium 235. It contains not less than 85.0 per-
cent and not more than 115.0 percent of the la-
beled amount of 133Xe at the date and time indi-
. 0.031 MeV is not less than 95.0% of the total radioactivity
cated in the labeling.
Official from May 1, 2016
Copyright (c) 2016 The United States Pharmacopeial Convention. All rights reserved.
Official Monographs / Xenon 6395
Packaging and storage—Preserve in single-dose or in
multiple-dose vials having leak-proof stoppers, at room tem-
perature.
Other requirements—It meets the requirements for Label-
ing, except for the information specified for Labeling under
Injections; for Radionuclide identification; and for Radionuclidic
purity and Assay for radioactivity under Xenon Xe 133 Injec-
tion, except to determine the radioactivity in MBq (mCi) per
container.
Xenon Xe 133 Injection
.
» Xenon Xe 133 Injection is a sterile, isotonic so-
lution of Xenon 133 in Sodium Chloride Injection
suitable for intravenous administration. Xenon
133 is a radioactive nuclide prepared from the
fission of uranium 235. It contains not less than
90.0 percent and not more than 110.0 percent of
the labeled amount of Xenon 133 at the date
and time stated on the label.
Packaging and storage—Preserve in single-dose contain-
ers that are totally filled, so that any air present occupies
not more than 0.5% of the total volume of the container.
Store at a temperature between 2° and 8°. If there is free
space above the solution, a significant amount of the xenon
133 is present in the gaseous phase. Glass containers may
darken under the effects of radiation.
Change to read:
Labeling—Label it to include the following, in addition to
USP Monographs
the information specified for •Labeling 〈7〉, Labels and Label-
.
ing for Injectable Products• (CN 1-May-2016): the time and date of
calibration; the amount of xenon 133 expressed as total
megabecquerels (microcuries or millicuries), and concentra-
tion as megabecquerels (microcuries or millicuries), per mL
at the time of calibration; the expiration date; the name and
amount of any added bacteriostatic agent; and the state-
ment “Caution—Radioactive Material.” The labeling indi-
cates that in making dosage calculations, correction is to be
made for radioactive decay, and also indicates that the radi-
oactive half-life of 133Xe is 5.24 days.
.
USP Reference standards 〈11〉—
USP Endotoxin RS
Radionuclide identification (see Radioactivity 〈821〉)—Its
gamma-ray and X-ray spectra are identical to those of a
known specimen of xenon 133 that exhibits two major
photopeaks having energies of 0.081 MeV and 0.031 MeV
(X-ray peak).
Change to read:
•Bacterial Endotoxins Test 〈85〉• (CN 1-May-2016)—It contains
not more than 175/V USP Endotoxin Unit per mL of the
Injection, when compared with the USP Endotoxin RS, in
which V is the maximum recommended total dose, in mL,
at the expiration date or time.
pH 〈791〉: between 4.5 and 8.0.
Radionuclidic purity—Using a suitable counting assembly
(see Selection of a Counting Assembly under Radioactivity
〈821〉), determine the radioactivity of Xe 133 in the Injec-
tion by use of a calibrated system as directed under Radioac-
tivity 〈821〉. The radioactivity exhibited at 0.081 MeV and
of the specimen.