Chemistry - nonvolatile residues by gravimetry

Total extractable content provides the big picture - regardless of individual compound identity, bulk organic contamination indicates material quality problems, cleaning inadequacy, or contamination requiring investigation. Non-volatile residue determination by gravimetric analysis following Ph. Eur. and USP requirements provides total extractable content measurement critical for quality control and biocompatibility assessment through definitive quantification regardless of chemical identity. The evaporation and weighing approach delivers straightforward measurement of all non-volatile extractables by removing solvent and measuring remaining solid residue, providing total organic burden assessment. This fundamental measurement supports risk assessment by establishing total exposure levels when individual compound identification proves impractical, validates cleaning processes by confirming residue removal to acceptable levels, and provides quality control metrics for batch release demonstrating consistent material quality. Essential for devices where total extractable content affects functionality including optical clarity or surface properties, safety assessment requiring exposure quantification when comprehensive identification exceeds practical limits, or quality control where trending identifies material degradation or supplier quality changes. For manufacturing validation, gravimetric analysis confirms cleaning processes achieve specified residue removal regardless of contamination composition, while incoming material inspection detects quality variations suggesting supplier problems. The testing proves particularly valuable for complex materials with numerous extractables where individual quantification becomes impractical, enabling overall contamination assessment. Pharmaceutical packaging materials require gravimetric testing demonstrating low extractable content preventing drug product interaction, while implantable device materials need assessment ensuring total organic burden remains within biocompatibility acceptable limits. The simple methodology enables rapid screening supporting real-time quality decisions, while trending reveals batch-to-batch variations requiring investigation of manufacturing consistency or raw material quality.

No.
10062344
Method
Evaporation of extract, gravimetric determination
Stage category
Analyses category
Sample type
Finished device, Bulk material
Sample requirement (type)
Sterile or non sterile
Sample quantities
120 cm2, 20 gram
Lead Time Standard (Days)
10
Lead Time Express (Days)
5
Lead Time Super Express (Days)
unavailable
Test facility
Partner Lab
GLP
No
Add this test to cart to request an offer.

Do you need some help?

Other similar tests

Ph.Eur. 2.2.44, Ph.Eur. Mono. 0008, Ph.Eur. Mono. 0169, USP 643, EN 1484, ASTM G136-03
Chemistry - TOC - water analysis

Water touches every aspect of pharmaceutical and medical device manufacturing, yet organic contamination invisible to standard testing can compromise products, harbor dangerous biofilms, and signal system failures before they become catastrophic. Total Organic Carbon analysis serves as the cornerstone of water quality assessment in pharmaceutical, medical device, and industrial applications, quantifying organic contamination in water systems critical for manufacturing, production, and environmental monitoring following EN 1484 and ASTM G136-03 standards. The combustion-oxidation method delivers precise measurements with detection limits suitable for ultrapure water validation through process water characterization, enabling comprehensive contamination assessment from pharmaceutical water systems to industrial process monitoring. Critical applications include validation of water treatment systems where TOC trending reveals membrane fouling or resin exhaustion, verification of cleaning processes where organic levels indicate sanitization effectiveness, and environmental compliance monitoring where discharge limits require documented organic content. The analysis supports quality control programs by establishing baseline values that enable detection of system breaches, trending water quality over time to identify gradual degradation suggesting maintenance needs, and correlating organic levels with microbial growth patterns. Particularly valuable for pharmaceutical water systems where organic contamination indicates microbial growth potential, biofilm formation creating endotoxin sources, or system degradation requiring intervention before contamination compromises products. For medical device manufacturers, TOC monitoring validates that rinse water quality supports cleaning validation claims and prevents organic transfer to devices during final processing. Results enable informed decisions about system maintenance timing, process improvements targeting contamination sources, and regulatory compliance strategies supporting USP and Ph. Eur. water specifications that increasingly emphasize organic contamination control.