Aztreonam For Injection Usp - White Or Off-white Crystalline Powder, 54.1% Aztreonam & 43.1% Arginine Content, Meets Usp Specifications

Aztreonam for Injetion USP (Bulk Drug) (Dry mixture for sterile Aztreonam & Arginine)
Grade -- USPA
Dosage Form -- Powder
Molecular Weight -- 435.433 g/mol
Molecular Formula -- C13H17N5O8S2
cAS No -- 78110-38-0
Systematic (IUPAC) Name -- 2-({[(1Z)-1-(2-amino-1,3-thiazol-4-yl) -2- {[(2S,3S)-2-methyl-4-oxo-1-sulfoazetidin-3-yl]amino} -2- oxoethylidene]amino}oxy)-2-methylpropanoic acid
Product Specification: -
Description -- White or off-white crystalline powder
Identification -- The retention times of the major peaks in the chromatogram of the Assay preparation correspond to those of the Standard preparation as obtained in the Assay
pH -- 4.5 ~ 7.5
Clarity and color of solutions -- Clear and Color is not more than Y2 or YG2
Water -- NMT 2.0%
Related substances -- Total impurities are not more than 2.0%
Related substances -- Any individual impurity is not more than 1.0%
Visible Particle -- Should meet the requirements
Particulate matter -- Should meet the requirements
Bacterial end toxins -- NMT 0.17 EU/mg
Sterility -- Should meet the requirement
Bulk Density -- NLT 0.45g/ml
Azteonam Assay -- 54.1%
Arginine Assay -- 43.1%
Assay -- It contains not less than 90.0 percent and not more than 105.0 percent of aztreonami C13H17N5O8S2i i calculated on the anhydrous And arginine-free basis
COnclusion -- The Product Complies with USP specification
Storage -- Preserve in tight, Store in well-closed, light resistant Containers.
Tags -- Aztreonam USP (Sterile), Aztreo,