MS Platform
Mass Spectrometry (MS), together with its advanced hyphenated variants—LC-MS/MS, GC-MS, Q-TOF-MS and ICP-MS, is a core foundational technology for high-sensitivity, high-specificity qualitative and quantitative analysis in the pharmaceutical industry. Conventional mass spectrometry realizes accurate detection and structural identification of target compounds based on mass-to-charge ratio (m/z) after ionization and separation. LC-MS/MS introduces high-performance liquid chromatography separation and tandem mass spectrometry detection, supporting precise targeted quantitative analysis; GC-MS adopts gas chromatography separation and is suitable for volatile and thermally stable compounds; Q-TOF-MS provides high-resolution accurate mass data and excels in unknown metabolite and impurity identification; ICP-MS realizes ultra-trace elemental analysis with extremely low detection limit, fully meeting strict regulatory requirements. The core advantages of LC-MS/MS, GC-MS, Q-TOF-MS and ICP-MS are compared in detail below:
| Technology Type | Core Advantages | Applicable Scenarios |
| LC-MS/MS | Ultra-high sensitivity, excellent specificity, strong anti-interference, wide linear range, ideal for targeted quantitative detection, recognized as the gold standard for bioanalysis |
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| GC-MS | High separation efficiency, standard spectral library matching, good stability, suitable for volatile and derivatizable compounds |
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| Q-TOF-MS | High-resolution accurate mass, powerful structural elucidation, non-targeted screening capability, efficient for unknown compound identification |
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| ICP-MS | Ultra-low detection limit, multi-element simultaneous analysis, high accuracy and precision, fully compliant with ICH Q3D guidelines |
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MS Platform
PharmaAnalytica has built a fully automated, high-precision integrated mass spectrometry technology platform dedicated to pharmaceutical bioanalysis and quality control, equipped with mainstream high-performance domestic analytical instruments to guarantee standardized, efficient and stable experimental operations.
LCMS-TQ9200 LC-MS/MS System
LCMS-TQ9200 consists of the LC3600 ultra-high performance liquid chromatograph and TQ9200 triple quadrupole mass spectrometer. Adopting ultra-high pressure linear motor pump, ultra-high pressure on-line lossless sampling, high-stability electrospray ion source and high-efficiency ion transmission lens, it enables ultra-sensitive and high-specificity quantitative detection in MRM mode with outstanding anti-matrix interference and long-term stability. The system achieves pg-level sensitivity and excellent reproducibility, and is widely used for trace quantification of drugs in plasma, urine and tissue samples, providing robust and compliant data support for pharmacokinetics, tissue distribution, bioequivalence studies and drug quality control.
EXPEC 3750 GC-MS
Adopting a high-sensitivity SIP electron impact ion source, inert alloy ion source design, and high-precision molybdenum quadrupole with pre‑quadrupole protection, it features outstanding stability, strong anti‑contamination ability and high qualitative accuracy. Equipped with standard spectral library and simultaneous SCAN/SIM acquisition mode, EXPEC 3750 realizes rapid identification and accurate quantitation of volatile compounds, residual solvents and derivatized small molecules. The system fully meets pharmacopoeial requirements and regulatory guidelines, and is widely used for residual solvent detection, volatile impurity analysis and drug safety testing in APIs and pharmaceutical formulations.
Q-TOF MS System LC-QTOF 7000
LC-QTOF 7000 provides high-resolution accurate mass measurement and multi-stage fragment information, supporting non-targeted screening and structural identification of unknown metabolites, degradation products and impurities. With high sensitivity and fast data acquisition speed, it serves as the core instrument for drug metabolism research, forced degradation studies, impurity profiling and drug-excipient compatibility evaluation.
SUPEC 7000 ICP-MS
Equipped with a high-sensitivity ion interface, an advanced hexapole collision reaction cell and a high-precision pure molybdenum quadrupole mass analyzer, SUPEC 7000 delivers ultra-low detection limits down to ppt level and excellent matrix tolerance for complex pharmaceutical samples. This system enables simultaneous multi-element determination, efficiently eliminates polyatomic interferences and ensures outstanding long‑term stability, fully complying with ICH Q3D elemental impurity guidelines and global pharmaceutical regulatory requirements. It is specially used for the quantitative analysis of heavy metals, catalyst residues and trace elemental impurities in APIs, excipients and finished pharmaceutical products, providing reliable safety evaluation throughout the drug lifecycle.
Covered Drug Categories for MS Analysis
Supported by our mature and stable integrated mass spectrometry platform, PharmaAnalytica provides customized, full-process analytical services covering a full spectrum of small-molecule drugs, innovative drugs, generic drugs, natural products and pharmaceutical preparations. We deliver targeted testing solutions for each drug type, matching corresponding mass spectrometry technologies to meet strict R&D and regulatory demands. The covered drug categories are listed as follows:
- Small-molecule APIs and finished pharmaceutical products
- Innovative small-molecule drugs and generic drugs
- Oral solid preparations, injections and topical formulations
- Natural products
- Drug metabolites and degradation products
- Pharmaceutical excipients and raw materials
Core MS-Based Bioanalysis Services
PharmaAnalytica leverages high-performance LC-MS/MS, GC-MS, Q-TOF-MS and ICP-MS technologies to provide compliant, standardized full-chain analytical services covering core research links of drug R&D, quality control and registration application. Each service type is elaborated below:
API & Formulation Quality Control
We carry out strict compliance testing including assay, related substances, residual solvents, elemental impurities and uniformity, fully meeting pharmacopeial standards and regulatory requirements for drug development and commercial release.
Drug Stability & Impurity Analysis
We conduct stress testing, accelerated stability, long-term stability and degradation product identification, clarifying degradation pathways and impurity profiles to support formulation optimization and shelf-life determination.
Drug Excipient Compatibility Assessment
We evaluate potential physical and chemical interactions between APIs and excipients, detect impurity increase and structural changes, providing scientific basis for excipient screening and formulation design.
Pharmacokinetics (PK) & Biodistribution Analysis
We precisely quantify drug concentration in plasma, urine, tissues and other biological matrices, calculate key PK parameters and reveal in vivo distribution characteristics, supporting efficacy and safety evaluation.
Metabolite Identification & Degradation Pathway Elucidation
We identify in vitro and in vivo metabolites, clarify metabolic soft spots and degradation mechanisms, providing key data support for lead compound optimization and drug safety assessment.
At PharmaAnalytica, we are committed to empowering the innovation of global pharmaceutical industry with reliable technical services and professional data support. Our high-precision mass spectrometry platform, integrated with automated workflows and compliant operating systems, is ready to partner with pharmaceutical enterprises, research institutions and global customers to accelerate the R&D pace of drugs and solve critical challenges in the analytical field. Whether it is preclinical research verification or clinical trial support, we will always adhere to the concept of "precision, compliance, and efficiency" to provide you with one-stop pharmaceutical analysis solutions, jointly promoting the transformation of scientific and technological achievements and making positive contributions to the development of global pharmaceutical cause.
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