LC/MS Equipment For Pharmaceutical Analysis

Overview
Chrom Technology supplies LC MS systems for impurity identification, quantitation, and advanced R And D. We integrate the LC front end, qualify the complete system, and keep it compliant and available.

What We Supply

• Triple quadrupole LC MS MS for targeted quantitation.

• High resolution LC MS such as QTOF class with accurate mass capability.

• Ion sources: ESI and APCI with switching and polarity control.

• UHPLC front ends, columns, and sample preparation accessories.

• Part 11 capable software with user management and audit trails.

Services Included

• URS drafting, site readiness, and utility checks.

• FAT and SAT coordination and acceptance.

• DQ, IQ, OQ, and PQ with system performance verification and tuning.

• Traceable calibration, lock mass verification, and check standards.

• Preventive maintenance and on-call repair with spare parts planning.

• Method enablement support and staff training.

Typical Pharma Uses
Impurity and degradant identification, nitrosamine assessment, extractables and leachables, peptide mapping, bioanalysis for small molecules.

Deliverables
Qualification packages, performance verification records, user and admin training logs, and service history.