Track topics on Twitter Track topics that are important to you
SIMS WELDING SUPPLY QUALITY ASSURANCE PROGRAM VERSION 8 AUGUST 2007 PAGE 128
8.11 CERTIFICATE OF ANALYSIS - OXYGEN USP
CERTIFICATE OF ANALYSIS OXYGEN LIQUEFIED
USP MEDICAL GRADE
TEST/REQUIREMENT NF SPECIFICATION LOT ANALYSIS ANALYTICAL METHOD
IDENTIFICATION PASS PARAMAGNETISM - SERVOMEX
ODOR NO APPRECIABLE ODOR ORGANOLEPTIC
CARBON DIOXIDE LESS THAN OR EQUAL TO 0.03% SEE NOTE SEE NOTE
CARBON MONOXIDE LESS THAN OR EQUAL TO 0.001% SEE NOTE SEE NOTE
ASSAY GREATER THAN OR EQUAL TO 99.6% PARAMAGNETISM - SERVOMEX
NOTE: USP/NF EXEMPTS FACILITIES THAT MANUFACTURE OXYGEN USP BY THE AIR LIQUEFACTION PROCESS FROM THE TESTS FOR CARBON DIOXIDE AND CARBON MONOXIDE. OUR OXYGEN USP IS MANUFACTURED BY THE AIR LIQUEFACTION PROCESS
THE METHODOLOGY BEING USED TO PERFORM THE USP/NF TEST FOR ASSAY IS INDICATED BELOW:
PARAMAGNETIC ANALYZER MODEL: SERVOMEX 5200
SUPPLIER SIGNATURE:_____________________________ DATE:___________________
THIS MATERIAL WAS FILLED IN ACCORDANCE WITH OUR STANDARD OPERATING PROCEDURES UTILIZED FOR THE MANUFACTURE OF MEDICAL GASES. THESE PROCEDURES ENSURE THAT PRODUCTS ARE SAFELY MANUFACTURED IN COMPLIANCE WITH THE FDA'S CURRENT GOOD MANUFACTURING PRACTICES (cGMP) REGULATIONS AND FDA MEDICAL GAS GUIDELINES FOR MEDICAL GAS CUSTOMERS. FOR NON-MEDICAL CUSTOMERS, THIS MATERIAL IS NOT APPROVED FOR HUMAN DRUG USE.
Sims Welding Supply Co, Inc.
Supplementary oxygen is routinely administered to patients, even those with adequate oxygen saturations, in the belief that it increases oxygen delivery. However, oxygen delivery depends n...
Long-term oxygen therapy improves survival in patients with severe hypoxia. However, some patients despite this oxygen, experience episodes of low oxygen levels (intermittent hypoxia) espe...
Patients with lung disease experiencing difficulty breathing can be treated with oxygen therapy. This involves the delivery of "extra" oxygen by a face-mask or through small tubes placed ...
To evaluate changes in activity based on the use of portable oxygen concentrators combined with standard of care (SOC) long- term oxygen therapy versus SOC long-term oxygen therapy alone a...
This study will evaluate patient comfort and oxygen delivery efficiency when providing supplemental oxygen through a nasal cannula to volunteers using an instrumented oxygen delivery syste...
A glucose/oxygen biofuel cell (BFC) that can operate continuously under oxygen-free conditions is described. The oxygen-deficit limitations of metabolite/oxygen enzymatic BFCs have been addressed by u...
Pulse oximetry-derived oxygen saturation is typically >97% in normoxia and hyperoxia, limiting its clinical use. The new Oxygen Reserve Index (ORi), a relative indicator of the partial pressure of oxy...
Oxygen is used for medical treatment and general anesthesia. However, high concentrations of oxygen can have toxic effects on cells. In veterinary medicine, 100% oxygen is usually used during general ...
Oxygen therapy is widespread in acute care settings as adequate oxygen supplementation is essential in case of hypoxemia. Excessive oxygen supplementation has several unrecognized deleterious effects....
Prescription and administration of oxygen in emergencies by healthcare providers are reported to be inappropriate in most settings. There is a huge gap in the knowledge of health care providers on var...
An assay is an analytic procedure for qualitatively assessing or quantitatively measuring the presence or amount or the functional activity of a target entity. This can be a drug or biochemical substance or a cell in an organism or organic sample. ...
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...