Accessed from 10.6.1.

1 by gsk on Tue Oct 18 09:02:08 EDT 2016

2348 Adenosine / Official Monographs

USP 39

LOSS ON DRYING 731

Analysis: Dry a sample at 105 for 2 h.
Acceptance criteria: NMT 0.5%
ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in tight, light-resistant
containers, and store at controlled room temperature.
USP REFERENCE STANDARDS 11
USP Adenine RS
USP Adenosine RS

Adenosine Injection
DEFINITION
Adenosine Injection is a sterile solution of Adenosine in
Water for Injection. It may contain Sodium Chloride. It
contains NLT 90.0% and NMT 110.0% of the labeled
amount of adenosine (C10H13N5O4).

USP Monographs

IDENTIFICATION
The retention time of the adenosine peak of the Sample
solution corresponds to that of the Standard solution, as
obtained in the Assay.
ASSAY
PROCEDURE
Mobile phase: Dissolve 2.0 g of monobasic potassium
phosphate in 800 mL of water. Add 5 mL of 1.0 M tetrabutylammonium dihydrogen phosphate, dilute with
water to 980 mL, and mix. Add 20 mL of acetonitrile.
System suitability solution: 0.03 mg/mL each of USP
Adenosine RS and inosine dissolved in warm water (50
to 55), and diluted with water
Standard solution: 0.03 mg/mL of USP Adenosine RS
dissolved in warm water (50 to 55), and diluted with
water to volume. Before addition of the warm water, if
sodium chloride is present in the Injection, add 0.01 mL
of a solution of sodium chloride (0.9 in 100) per mL of
the anticipated final volume of the Standard solution.
Sample solution: Nominally 0.03 mg/mL of adenosine,
from a suitable volume of Injection in water
Chromatographic system
(See Chromatography 621, System Suitability.)
Mode: LC
Detector: UV 254 nm
Column: 3.9-mm 30-cm; packing L1
Flow rate: 2.5 mL/min
Injection volume: 10 L
Run time: 2.5 times the retention time of adenosine
System suitability
Samples: System suitability solution and Standard
solution
[NOTEThe relative retention times of inosine and
adenosine are 0.43 and 1.0, respectively.]
Suitability requirements
Resolution: NLT 6.0 between adenosine and inosine,
System suitability solution
Tailing factor: NMT 2.0 for the adenosine peak, System suitability solution
Relative standard deviation: NMT 1.5%, Standard
solution
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of
adenosine (C10H13N5O4) in the portion of Injection
taken:
Result = (rU/rS) (CS/CU) 100
rU
rS

= peak response from the Sample solution

= peak response from the Standard solution

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 suitability: 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 volume 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 requirements 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 infusion, it contains NMT 5.95 USP Endotoxin Units/mg of
adenosine.
Change to read:

OTHER REQUIREMENTS: It meets the requirements under

Injections and Implanted Drug Products 1. (CN 1-May-2016)
.

ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in tight, single-dose
containers, preferably of Type I glass, and store at controlled 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 consisting 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 Acceptance 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.]

Official from August 1, 2016

Copyright (c) 2016 The United States Pharmacopeial Convention. All rights reserved.

Accessed from 10.6.1.1 by gsk on Tue Oct 18 09:02:08 EDT 2016

USP 39

Official Monographs / Alanine 2349

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.
Acceptance criteria: 19.5%23.5% of oxygen by
volume

ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in pressurized containers. Container connections shall be appropriate for air.
Adaptors shall not be used to connect containers to patient use supply system piping or equipment.
LABELING: Label states if Medical Air is a synthetic mixture 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
L-Alanine [56-41-7].

89.09

DEFINITION
Alanine contains NLT 98.5% and NMT 101.5% of L-alanine
(C3H7NO2), calculated on the dried basis.
IDENTIFICATION
A. INFRARED ABSORPTION 197K
ASSAY
PROCEDURE
Sample: 80 mg of Alanine
Titrimetric system
(See Titrimetry 541.)
Mode: Direct titration
Titrant: 0.1 N perchloric acid VS
Endpoint detection: Potentiometric
Blank: 3 mL of formic acid in 50 mL of glacial acetic
acid
Analysis: Dissolve the Sample in a mixture of 3 mL of
formic acid and 50 mL of glacial acetic acid, and titrate
with Titrant.
Calculate the percentage of L-alanine (C3H7NO2) in the
portion of Alanine taken:
Result = [(VS VB) N F 100]/W
VS
= Titrant volume consumed by the Sample (mL)
VB
= Titrant volume consumed by the Blank (mL)
N
= actual normality of the Titrant (mEq/mL)
F
= equivalency factor, 89.09 mg/mEq
W
= Sample weight (mg)
Acceptance criteria: 98.5%101.5% on the dried basis
IMPURITIES
RESIDUE ON IGNITION 281: NMT 0.15%
CHLORIDE AND SULFATE, Chloride 221
Standard solution: 0.70 mL of 0.020 N hydrochloric
acid
Sample: 1.0 g of Alanine
Acceptance criteria: NMT 0.05%
CHLORIDE AND SULFATE, Sulfate 221
Standard solution: 0.30 mL of 0.020 N sulfuric acid
Sample: 1.0 g of Alanine
Acceptance criteria: NMT 0.03%
IRON 241: NMT 30 ppm
Delete the following:

HEAVY METALS, Method I 231: NMT 15 ppm (Official 1.

Jan-2018)

RELATED COMPOUNDS
Mobile phase: 0.008 N sulfuric acid solution
System suitability solution: A mixture of 0.05 mg/mL
of USP Fumaric Acid RS, 0.05 mg/mL of USP Maleic
Acid RS, and 3 mg/mL of USP Malic Acid RS in water
Maleic acid standard solution: 0.05 mg/mL of USP
Maleic Acid RS in water
Malic acid standard solution: 3 mg/mL of USP Malic
Acid RS in water
Fumaric acid standard solution: 0.05 mg/mL of USP
Fumaric Acid RS in water

Official from August 1, 2016

Copyright (c) 2016 The United States Pharmacopeial Convention. All rights reserved.

USP Monographs

IMPURITIES
See Impurities Testing in Medical Gases Assay 413. The detector 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 detector 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 detector 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 oxidenitrogen 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.