What is the mass of zolbetuximab and excipients in 100 mg vials?

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Prescribing Information including BOXED WARNING

A 100 mg vial contains extractable zolbetuximab 100 mg, arginine 116.2 mg, sucrose 256.48 mg, polysorbate 80 1.05 mg and phosphoric acid max 59.7 mg

The maximum extractable amount of phosphoric acid per 100 mg vial is estimated from historical batches at 59.7 mg/vial, corresponding to 3.8 mg/mL of phosphorous after reconstitution.¹

Table 1. Composition of zolbetuximab 100 mg vial^a,¹

Component	Extractable amount^b	Theoretical unit amount^c
Zolbetuximab	100 mg	105 mg^d
Arginine	116.2 mg	122 mg
Phosphoric acid	sufficient quantity to pH 6.0^e	sufficient quantity to pH 6.0^e
Sucrose	256.48 mg	269.3 mg
Polysorbate 80	1.05 mg	1.1 mg

^a Nitrogen gas is used for backfilling and contained in the headspace of zolbetuximab vial.

^b Extractable amount refers to the quantity that a trained healthcare professional should be able to retrieve from the reconstituted solution when following the recommended reconstitution and extraction procedures.

^cTheoretical amount refers to the quantity of zolbetuximab and excipients added to the vial to enable extraction of 100 mg of zolbetuximab.

^dEach vial contains an overfill of zolbetuximab relative to the nominal content (100 mg/vial) to ensure the deliverable dose is provided in each vial.

^eThe estimated maximum extractable amount of phosphoric acid per vial from the historical batches is 59.7 mg/vial, corresponding to 3.8 mg/mL of phosphorous after reconstitution. The upper limit for extractable amount of phosphoric acid per vial based on safety data is 67.9 mg/vial.