Accessed from 10.6.1.
1 by schering on Fri Jun 12 00:31:37 EDT 2015
2064 Adenosine / Official Monographs
CS = concentration of USP Adenosine RS in the
Standard solution (mg/mL)
CU = nominal concentration of adenosine in the
Sample solution (mg/mL)
Acceptance criteria: 90.0%110.0%
IMPURITIES
ORGANIC IMPURITIES
Mobile phase, System suitability solution, Standard
solution, Chromatographic system, and System suit-
ability: Proceed as directed in the Assay.
Sample solution: Nominally 0.3 mg/mL of adenosine
from a volume of Injection, in water
Analysis
Sample: Sample solution
Calculate the percentage of each impurity in the vol-
ume of Injection taken:
Result = (rU/rT) 100
rU = peak response for each impurity
rT = sum of the responses of all of the peaks
Acceptance criteria
Any individual impurity: NMT 1.0%
Total impurities: NMT 1.5%
SPECIFIC TESTS
PH 791: 4.57.5
PARTICULATE MATTER IN INJECTIONS 788: It meets the re-
quirements for small-volume injections.
BACTERIAL ENDOTOXINS TEST 85: When the product is
used for rapid intravenous injection, it contains NMT
11.62 USP Endotoxin Units/mg of adenosine. When the
product is used for continuous peripheral intravenous in-
fusion, it contains NMT 5.95 USP Endotoxin Units/mg of
adenosine.
OTHER REQUIREMENTS: It meets the requirements under
Injections 1.
USP Monographs
ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in tight, single-dose
containers, preferably of Type I glass, and store at con-
trolled room temperature.
USP REFERENCE STANDARDS 11
USP Adenosine RS
USP Endotoxin RS
.
Medical Air
DEFINITION
Medical Air is a natural or synthetic mixture of gases consist-
ing largely of nitrogen and oxygen. It contains NLT
19.5% and NMT 23.5%, by volume, of oxygen (O2).
IDENTIFICATION
A. The paramagnetic signal exhibited by the Sample gas
in the Assay confirms the presence of oxygen.
B. The Sample gas in the Assay meets the assay Accep-
tance criteria.
ASSAY
PROCEDURE
The certified standards called for in the following test are
listed in Reagents, Indicators, and Solutions.
Zero gas: Nitrogen certified standard
Span gas: 21% Oxygen certified standard. [NOTESee
Reagents, Indicators, and Solutions.]
Sample gas: Medical Air
Mode: Paramagnetic oxygen measurement (see Medical
Gases Assay 415)
Analysis: Determine the concentration of oxygen in
percentage by volume of Medical Air using a suitable
paramagnetic analyzer.
Official from May 1, 2015
Copyright (c) 2015 The United States Pharmacopeial Convention. All rights reserved.
USP 38
Acceptance criteria: 19.5%23.5% of oxygen by
volume
IMPURITIES
See Impurities Testing in Medical Gases Assay 413. The de-
tector tubes called for in the following tests are listed in
Reagents, Indicators, and Solutions.
If the label indicates that Medical Air is a synthetic mixture
of oxygen and nitrogen, and where oxygen complies to
Oxygen USP and Nitrogen complies to Nitrogen NF, then
the Impurities tests are not required.
LIMIT OF CARBON DIOXIDE
Sample: Detector tube manufacturers recommended
volume 5% of Medical Air
Analysis: Pass the Sample through a carbon dioxide de-
tector tube at the rate specified for the tube by the
detector tube manufacturer.
Acceptance criteria: NMT 500 ppm
LIMIT OF CARBON MONOXIDE
Sample: Detector tube manufacturers recommended
volume 5% of Medical Air
Analysis: Pass the Sample through a carbon monoxide
detector tube at the rate specified for the tube by the
detector tube manufacturer.
Acceptance criteria: NMT 10 ppm
LIMIT OF SULFUR DIOXIDE
Sample: Detector tube manufacturers recommended
volume 5% of Medical Air
Analysis: Pass the Sample through a sulfur dioxide de-
tector tube at the rate specified for the tube by the
detector tube manufacturer.
Acceptance criteria: NMT 5 ppm
LIMIT OF NITRIC OXIDE AND NITROGEN DIOXIDE
Sample: Detector tube manufacturers recommended
volume 5% of Medical Air
Analysis: Pass the Sample through a nitric oxideni-
trogen dioxide detector tube at the rate specified for
the tube by the detector tube manufacturer.
Acceptance criteria: NMT 2.5 ppm
LIMIT OF WATER AND OIL
Analysis: Support one container in an inverted position
(with the valve at the bottom) for 5 min. Cautiously
open the valve slightly, maintaining the container in an
inverted position. Vent the gas with a barely audible
flow against a stainless steel mirror for a few seconds.
Acceptance criteria: No liquid is discernible on the
mirror.
ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in pressurized contain-
ers. Container connections shall be appropriate for air.
Adaptors shall not be used to connect containers to pa-
tient use supply system piping or equipment.
LABELING: Label states if Medical Air is a synthetic mix-
ture of Oxygen USP and Nitrogen NF. Where it is piped
directly from the collecting tank to the patient point of
use, label each outlet Medical Air.
.
Alanine
C3H7NO2 89.09
L-Alanine [56-41-7].