Page 62 - Pharmaceutical Solution for Pharma Analysis

Compliance with Data Integrity Requirements: Qualitative Analysis of Unknown Compounds: Smart EI/CI Ion Source
GCMS-LabSolutions Analytical Data Management System Using a mass spectral library is an extremely convenient and reliable technique for identifying compounds. However, sometimes impurities and
newly synthesized compounds are not registered in the library. Positive chemical ionization (CI) has conventionally been used to obtain
Many users, especially in the pharmaceutical industry, require compliance with regulations and guidelines, such as the CSV, PIC/S GMP, and
Japanese Ministry of Health, Labour and Welfare ER/ES guidelines and FDA 21 CFR Part 11. They also are requiring more appropriate and molecular ion information for qualitative analysis of such compounds, but that requires exchanging ion sources when switching between EI
efficient means of maintaining and managing instruments and analytical data. Therefore, starting with version 4.45, GCMSsolution is now and CI modes.
compatible with LabSolutions DB/CS, so that LabSolutions can be used to manage analytical files and users for GC-MS systems. In contrast, the newly developed Smart EI/CI ion source can be used to acquire data using either EI or CI modes without exchanging ion sources.
●Using LabSolutions for Integrated Management of Analytical Instruments, Including GC-MS Systems ●The high sensitivity of the revolutionary ion source results in no noticeable difference compared to
LabSolutions DB/CS systems can reduce data management costs by integrating the management of analytical files and user using dedicated ion sources, either for EI or CI modes.
information for other analytical instruments as well. ●Easily switchable between EI and CI modes without exchanging ion sources.
●Excellent Traceability Functionality ●In combination with a DI direct sample inlet unit, mass spectra can be acquired easily in either EI or
The outstanding functionality for traceability supports maintaining audit trails for analytical files. Analytical files and operation
histories are safely managed in a LabSolutions database, so that the necessary information can be easily accessed at any time. CI mode.
●Efficient Operation Under High-Security Conditions
The system includes functionality for automatically locking the system after no operations have been performed for a given period,
and for switching between different users during a series of consecutive analyses. These functions help ensure that the system can be EI Comparison EI Ion Source Smart EI/CI Ion Source (EI Mode)
operated efficiently under high-security conditions.
S/N:37.7 S/N:30.8
Integrated Management of GC and Integrated (Networked) Management Diazinon 1.00 1.5
GC-MS Systems from One PC of Multiple Analytical Instruments (10 ng/mL, 1 µL injection)
LabSolutions DB + GCMSsolution LabSolutions CS + GCMSsolution 0.50 1.0
0.5

11.25 11.50 11.75 12.00 11.25 11.50 11.75 12.00

Client PC S/N:16.2
LabSolutions database 5.0 1.00 S/N:14.3
Phenthoate
(10 ng/mL, 1 µL injection)
3.0
Acquisition 0.50
control PC
1.0

13.25 13.50 13.75 14.00 13.25 13.50 13.75 14.00
• GC-MS System with GC Detector
The GCMS model, whether or not an HS unit or FID
detector is connected, can be changed according to Smart EI/CI Ion Source
customer preferences. For more information about Switchable without exchanging ion sources
system configurations, contact your Shimadzu
representative. GC LC GCMS
CI Comparison CI Ion Source Smart EI/CI Ion Source (CI Mode)
S/N:106.5 S/N:92.2
System for Confirming Synthesized Compounds: DI-2010 Direct Sample Inlet Unit
Direct sample injection (DI) is a method of bypassing the gas chromatograph (GC) and injecting samples
directly into the ion source. The technique is especially useful for applications such as measuring the mass Caffeine
spectra of synthesized compounds. It is also easy to use; simply attach a direct inlet unit to the GC-MS system (100 ng/mL, 1 µL injection)
configuration normally used. GC is not well suited to analyzing compounds that thermally decompose easily
or that are difficult to vaporize, but using the DI method makes it easy to confirm the mass spectra of such
11.75 12.00 12.25 12.50 11.75 12.00 12.25 12.50
compounds.
100 M+H + 100
M+H +
Caffeine (MW:194) 75 75
(1 µg/mL, 1 µL injection)
50 50
25 25
0 0
50 100 150 200 250 50 100 150 200 250

In the CI mode, using isobutane as the reagent gas is recommended, because it makes it easier to detect protonated molecules.
Example of Using DI-EI to Analyze Reserpine The Smart EI/CI ion source is an optional product. It can be used with GCMS systems capable of chemical ionization.