| |
Pharmaceutical Expertise -
USP, EP and JP Gases
|
|
| |
|
|
| |
|
|
| |
Atlantic Analytical has
methods in place for USP, EP and JP Nitrogen, Oxygen, Carbon Dioxide and
Air.
Atlantic Analytical has
demonstrated the analytical validity of analyzing for a 20ppm
limit of Oxygen in NF Nitrogen by MS as an improvement to
USP NF GC-TCD methodology while establishing an
MS method quantitation limit of 10 ppm Oxygen in Nitrogen.
The current method for Assay and Limit of Oxygen provides
for the analysis of Nitrogen by Gas Chromatography (GC) with
Thermal Conductivity Detection (TCD). This method does not
provide a valid quantitation limit for Oxygen, since the Oxygen
and Argon chromatographic peaks overlap, and only provides
a method for the determination of the Limit of Oxygen as less
than 1.0%, and a corresponding assay of Nitrogen to 99.0%.
This methodology is not designed to produce accurate Oxygen
quantitation in low ppm amounts, which limits the value of
the information the analysis is capable of providing to pharmaceutical
industries with tighter controls on Oxygen content in their
Nitrogen manufacturing raw material. |
|
|
|
|
| |
|
|
| |
|
|
Our
completed validation provides
you with a fully validated method for analyzing Nitrogen for
a specification limit of 20 ppm Oxygen, and a quantitation limit
of 10 ppm, which in accordance with reporting for Assay
Nitrogen shall produce an Assay value to 99.999+% Nitrogen (excluding
Argon). |
|
|
| |
|
|
