Quality Control
Qihe Biotech's rigorous product-quality management system — comprehensive quality assurance from incoming raw-material inspection to final product release.
Quality Management System
Qihe Biotech operates a full product-lifecycle quality management system in strict compliance with ISO 9001:2015 requirements. From raw-material procurement to finished-goods dispatch, every step has clearly defined quality-control checkpoints and traceable records.
Our QMS encompasses five major processes: supplier management, incoming quality control (IQC), in-process quality control (IPQC), outgoing quality control (OQC) and pre-shipment review.
Incoming Quality Control (IQC)
Upon receipt of each raw-material lot, the QA team conducts incoming inspection against the following criteria:
- Supplier qualification review: all raw-material suppliers must hold ISO certification or provide a Certificate of Analysis (CoA)
- Visual inspection and packaging integrity: check outer packaging condition and label accuracy
- HPLC purity analysis: target compound purity must be ≥ 95% for acceptance
- LC-MS molecular weight confirmation: measured value within ≤ 0.5 Da of the theoretical mass
- Additional testing for critical raw materials: NMR structural confirmation, moisture content (Karl Fischer)
In-Process Quality Control (IPQC)
During synthesis, purification and formulation, each critical step undergoes intermediate testing:
- TLC / HPLC monitoring of reaction progress
- Intermediate purity testing (HPLC, area-normalization method)
- Quality records for critical steps (reaction temperature, time, pH)
- Fraction analysis during column chromatography / preparative HPLC purification
Outgoing Quality Control (OQC)
Full-panel testing is performed before releasing any product; each lot is issued a Certificate of Analysis:
| Test item | Method | Release criterion |
|---|---|---|
| Appearance | Visual inspection | Conforms to reference standard |
| Purity (HPLC) | Area normalization | ≥ 95% |
| Molecular weight (LC-MS) | ESI+/ESI− | Theoretical value ± 0.5 Da |
| Solubility | Tested in recommended solvent | Clear solution, no insoluble particles |
| Fluorescence spectrum | Fluorescence spectrophotometer | λex/λem within specification |
| Moisture content | Karl Fischer | ≤ 0.5% |
Lot Traceability & Stability
Each product lot is assigned a unique Lot No. with complete records covering raw-material sources, synthesis logs, purification conditions and quality data. All QC records are retained for at least 5 years.
Key products undergo long-term stability monitoring at 4°C and -20°C with scheduled testing at 6, 12 and 24 months to verify quality consistency throughout the stated shelf life.
📵 Online lookup: Enter the catalog number and lot number on the CoA Query page to download the Certificate of Analysis for any lot.
Look up product Certificate of Analysis
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