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Samples: Standard solution and Sample solution • B. The Sample gas in the Assay meets the assay Accep-
Calculate the percentage of the labeled amount of tance criteria.
adenosine (C10H13N5O4) in the portion of Injection ASSAY
taken: • PROCEDURE
Result = (rU/rS) × (CS/CU) × 100 The certified standards called for in the following test are
listed in Reagents, Indicators, and Solutions.
rU = peak response from the Sample solution Zero gas: Nitrogen certified standard
rS = peak response from the Standard solution Span gas: 21% Oxygen certified standard. [NOTE—See
CS = concentration of USP Adenosine RS in the Reagents, Indicators, and Solutions.]
Standard solution (mg/mL) Sample gas: Medical Air
CU = nominal concentration of adenosine in the Mode: Paramagnetic oxygen measurement (see Medical
Sample solution (mg/mL) Gases Assay 〈415〉)
Acceptance criteria: 90.0%–110.0% Analysis: Determine the concentration of oxygen in
percentage by volume of Medical Air using a suitable
IMPURITIES paramagnetic analyzer.
• ORGANIC IMPURITIES Acceptance criteria: 19.5%–23.5% of oxygen by
Mobile phase, System suitability solution, Standard volume
solution, Chromatographic system, and System suit-
ability: Proceed as directed in the Assay. IMPURITIES
Sample solution: Nominally 0.3 mg/mL of adenosine See Impurities Testing in Medical Gases Assay 〈413〉. The de-
from a volume of Injection, in water tector tubes called for in the following tests are listed in
Analysis Reagents, Indicators, and Solutions.
Sample: Sample solution If the label indicates that Medical Air is a synthetic mixture
Calculate the percentage of each impurity in the vol- of oxygen and nitrogen, and where oxygen complies to
ume of Injection taken: Oxygen USP and Nitrogen complies to Nitrogen NF, then
the Impurities tests are not required.
Result = (rU/rT) × 100 • LIMIT OF CARBON DIOXIDE
Sample: Detector tube manufacturer’s recommended
rU = peak response for each impurity volume ±5% of Medical Air
rT = sum of the responses of all of the peaks 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 manufacturer’s recommended
volume ±5% of Medical Air
Analysis: Pass the Sample through a carbon monoxide VB = Titrant volume consumed by the Blank (mL)
detector tube at the rate specified for the tube by the N = actual normality of the Titrant (mEq/mL)
detector tube manufacturer. F = equivalency factor, 89.09 mg/mEq
Acceptance criteria: NMT 10 ppm W = Sample weight (mg)
• LIMIT OF SULFUR DIOXIDE Acceptance criteria: 98.5%–101.5% on the dried basis
Sample: Detector tube manufacturer’s recommended
volume ±5% of Medical Air IMPURITIES
Analysis: Pass the Sample through a sulfur dioxide de- • RESIDUE ON IGNITION 〈281〉: NMT 0.15%
tector tube at the rate specified for the tube by the • CHLORIDE AND SULFATE, Chloride 〈221〉
detector tube manufacturer. Standard solution: 0.70 mL of 0.020 N hydrochloric
Acceptance criteria: NMT 5 ppm acid
• LIMIT OF NITRIC OXIDE AND NITROGEN DIOXIDE Sample: 1.0 g of Alanine
Sample: Detector tube manufacturer’s recommended Acceptance criteria: NMT 0.05%
volume ±5% of Medical Air • CHLORIDE AND SULFATE, Sulfate 〈221〉
Analysis: Pass the Sample through a nitric oxide–ni- Standard solution: 0.30 mL of 0.020 N sulfuric acid
trogen dioxide detector tube at the rate specified for Sample: 1.0 g of Alanine
the tube by the detector tube manufacturer. Acceptance criteria: NMT 0.03%
Acceptance criteria: NMT 2.5 ppm • IRON 〈241〉: NMT 30 ppm
• LIMIT OF WATER AND OIL
Analysis: Support one container in an inverted position Delete the following:
(with the valve at the bottom) for 5 min. Cautiously
open the valve slightly, maintaining the container in an •• HEAVY METALS, Method I 〈231〉: NMT 15 ppm• (Official 1-
inverted position. Vent the gas with a barely audible
.
Jan-2018)
flow against a stainless steel mirror for a few seconds. • RELATED COMPOUNDS
Acceptance criteria: No liquid is discernible on the Mobile phase: 0.008 N sulfuric acid solution
mirror. System suitability solution: A mixture of 0.05 mg/mL
ADDITIONAL REQUIREMENTS of USP Fumaric Acid RS, 0.05 mg/mL of USP Maleic
• PACKAGING AND STORAGE: Preserve in pressurized contain- Acid RS, and 3 mg/mL of USP Malic Acid RS in water
ers. Container connections shall be appropriate for air. Maleic acid standard solution: 0.05 mg/mL of USP
Adaptors shall not be used to connect containers to pa- Maleic Acid RS in water
tient use supply system piping or equipment. Malic acid standard solution: 3 mg/mL of USP Malic
• LABELING: Label states if Medical Air is a synthetic mix- Acid RS in water
ture of Oxygen USP and Nitrogen NF. Where it is piped Fumaric acid standard solution: 0.05 mg/mL of USP
directly from the collecting tank to the patient point of Fumaric Acid RS in water
use, label each outlet “Medical Air”. Sample solution: 100 mg/mL of Alanine in water
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
USP Monographs
Mode: LC
Detector: UV 214 nm
Column: 7.8-mm × 30-cm; 9-µm packing L17
.