CHINST Qilin-2 Portable Mass Spectrometer for Rapid Screening of Illicit Additives in Dietary Supplements
| Brand | CHINST |
|---|---|
| Origin | Guangdong, China |
| Manufacturer Type | Manufacturer |
| Product Origin | Domestic (China) |
| Model | Qilin-2 |
| Pricing | Upon Request |
Overview
The CHINST Qilin-2 is a purpose-built portable mass spectrometer engineered for on-site, real-time detection of unauthorized pharmaceutical compounds in dietary supplements. Leveraging ambient ionization–based direct analysis (e.g., DART or DESI-compatible interface) coupled with time-of-flight (TOF) or quadrupole mass analyser architecture, the instrument enables rapid qualitative and semi-quantitative screening without extensive sample preparation. Designed specifically for regulatory field labs, quality control units, and food & drug inspection agencies, the Qilin-2 meets the operational demand for speed, portability, and method robustness in non-targeted and targeted adulterant monitoring. Its core application scope includes solid dosage forms (capsules, tablets, granules, pills, powders) and liquid formulations (tonic wines, oral solutions), with validated performance against over 30 high-risk illicit additives across six therapeutic categories.
Key Features
- Portable form factor (< 8 kg) with integrated battery support for >4 hours of continuous operation in field environments.
- Sub-ppm method detection limit (MDL) for key analytes—e.g., <1 ppm for rotundine and <20 ppb for standardized reference standards under optimized acquisition conditions.
- Three-step streamlined workflow: (1) Sample placement on integrated holder; (2) One-button initiation of ambient desorption/ionization; (3) Automated spectral interpretation and result reporting via embedded algorithm library.
- Minimal sample requirement: ≤0.1 mL for liquids; ≤10 mg for solids—no derivatization, no chromatographic separation required.
- Pre-loaded, category-specific method packages covering weight-loss, aphrodisiac, antihypertensive, sedative-hypnotic, hypoglycemic, and antitussive formulations.
- Ruggedized housing rated IP54 for dust and splash resistance; compliant with IEC 61000-4 electromagnetic compatibility standards.
Sample Compatibility & Compliance
The Qilin-2 supports direct analysis of intact dosage forms without extraction or cleanup, minimizing matrix interference and procedural error. It has been validated per ISO/IEC 17025:2017 general requirements for competence of testing and calibration laboratories. Method performance aligns with relevant Chinese Pharmacopoeia (ChP) monographs and CFDA Technical Guidelines for Screening of Illegal Additives in Health Foods (2020 Edition). While not intended for definitive quantitative compliance under GLP, its screening output satisfies preliminary risk assessment criteria required by national food safety surveillance programs and supports triage decisions prior to confirmatory LC-MS/MS analysis. All spectral libraries are traceable to NIST MS Search v2.3 and internal reference standards certified to GB/T 27404–2008 (Laboratory Quality Control Guidelines).
Software & Data Management
The instrument operates on CHINST SpectrumView™ v3.1 firmware—a Windows Embedded OS platform with touch-optimized UI. Software features include: customizable report templates (PDF/CSV export), audit-trail-enabled user log (meeting FDA 21 CFR Part 11 basic requirements for electronic records), spectral library update via secure OTA protocol, and configurable alarm thresholds for compound class–specific alerts. Raw data (.raw) and processed spectra (.msp) are stored locally with optional encrypted cloud backup (AES-256). Integration with LIMS is supported via HL7 and ASTM E1384-compliant API endpoints.
Applications
- Routine surveillance of health food markets by provincial drug administration offices.
- On-site verification during GMP audits of contract manufacturers producing dietary supplements.
- Emergency response screening during foodborne illness investigations involving adulterated products.
- Academic research into emerging adulterants and structural analogs (e.g., novel PDE5 inhibitors).
- Training platform for analytical chemistry students focusing on ambient MS principles and regulatory toxicology workflows.
FAQ
Is the Qilin-2 suitable for quantitative analysis?
No—it is designed as a rapid qualitative/semi-quantitative screening tool. Quantification requires orthogonal confirmation using calibrated LC-MS/MS per ISO 17025-accredited methods.
Does it require carrier gas or vacuum pump maintenance?
No external gas supply is needed; the system employs self-contained miniaturized turbomolecular pumping and ambient ionization, eliminating routine consumables beyond standard calibration kits.
Can spectral libraries be customized or expanded?
Yes—users may import custom .msp files or request vendor-supported library updates aligned with newly listed prohibited substances published by NMPA or WHO.
What training and documentation are provided?
CHINST supplies operator manuals, SOP templates compliant with CNAS-CL01, and remote/virtual instructor-led training modules covering method setup, troubleshooting, and data review protocols.
