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DARZALEX®

(daratumumab)

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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

DARZALEX® (daratumumab)

Medical Information

DARZALEX - Density, Specific Gravity, and Overfill Volume

Last Updated: 10/22/2025

SUMMARY

  • The content of DARZALEX (100 mg/5 mL and 400 mg/20 mL) containing sorbitol:

Density, Specific Gravity, and Overfill Volume of DARZALEX Containing Sorbitol1-3
Formulation
Density (g/mL)
Specific Gravity
Approximate Overfill Volume (mL)
DARZALEX (100 mg/5 mL)
1.022 at 20°C
1.0173 in normal saline
0.2-0.4
DARZALEX (400 mg/20 mL)
0.4-1.2

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 20 October 2025.

References

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1 Data on File. DARZALEX VIAL (100 AND 400 MG) 3.2.P.2.2.3 PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES - GEN 2; 2015.  
2 Data on File. Janssen Scientific Affairs, LLC. Correspondence from Janssen Research and Development, LLC (Communication dated 23 May 2023); 2025.  
3 Data on File. DARZALEX VIAL (100 AND 400 MG) 3.2.P.2.3 Manufacturing Process Development Control Strategy Development – In – Process Controls – Cilag VFL2 Gen 2; 2015.