Rapid Quality Assessment of Ceftriaxone Using Near-Infrared Spectroscopy

Ceftriaxone for injection, USP is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration.  Ceftriaxone sodium is a white to yellowish crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The color of ceftriaxone sodium solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Each vial contains ceftriaxone sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams of ceftriaxone activity. Ceftriaxone sodium contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity.

Intra-lot variability was detected in the spectra of 6 vials of ceftriaxone sampled from one lot.  One of the vials was more than 8.3 multidimensional SDs away from the center of the cluster of the other 5 vials from the same lot, suggesting that the manufacturing process may not be in a state of control. Interlot variability was detected between two lots of the drug using a subcluster detection test (r_tn=0.9629, r_ts=0.9148, p=0.02).