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LC-MS/MS
Make & Model: Agilent 6470 Triple Quadrupole LC- MS/MS System
Mass Range: m/z 5-3000
Ion Source: ESI & APCI
Nitrosamines Method Developments, Validation
Identification of unknown peaks
E&L Studies Ref. USP 1663/1664
Regular Batch Analysis
Genotoxic Impurities
Identification
Quantification
Carcinogenic Impurities
GC-MS/MS
Make & Model: Agilent 7010B
Source: Electron Ionization
Identification of unknown peaks
Regular Batch Analysis
E&L Studies Ref. USP 1663/1664
Nitrosamines Method Developments, Transfer,Validations & Verifications
USP 1469
ICP -MS
Make & Model: Agilent 7850 ICP-MS
Method Developments, Transfer, Validations & Verifications
Regular Batch Analysis
E&L Studies
USP 232 & 233
ICH Q3D
Trace Metal analysis
Microwave Digestion SPL
HPLC & UPLC
Make & Model: Agilent 1290 Infinity-II UPLC & Agilent 1260 Infinity-II HPLC
Pressure: 1290 Infinity-II; Maximum 1300 bar & 1260 Infinity-II; Maximum 600 bar
Detectors: DAD, RID, VWD & FLD
Method Development, Transfer, Validation & Verifications
Regular Batch Analysis (Assay, Purity, Content Methods, Related Substances)
ICH Q2(R1)
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