Certificate of Analysis Guide¶
COA Document Structure¶
Each Solarbio COA includes:
| Section | Content | Example Values |
|---|---|---|
| Header | Product name, SKU, lot number, manufacturing date | lot: SR20240401, mfg: 2024-04-15 |
| Specification Table | Parameter, specification limit, test result, test method | Appearance: white powder; Conforms |
| Physical Properties | Appearance, color, physical state, solubility | White crystalline powder; soluble in DMSO |
| Chemical Analysis | Purity (HPLC/GC), pH, moisture, identity (NMR, MS) | HPLC ≥99.0%; found 99.3% |
| Biological Testing | Activity assay, endotoxin, sterility (if applicable) | Endotoxin <0.5 EU/mL |
| Approval | QA signature, release date, approval status | Approved 2024-04-20 |
Test Parameters by Product Category¶
| Product Category | QC Tests | Specification Limit | Method |
|---|---|---|---|
| PCR master mixes | Activity assay, DNase test, RNase test, sterility | Amplification efficiency >90% of reference; Nuclease negative | qPCR (GAPDH target); Fluorogenic substrate |
| DNA polymerases | Specific activity, exonuclease, endonuclease | 50–100 U/µL; Nuclease negative | Radioactive substrate; Plasmid digestion |
| ELISA kits | Calibrator recovery, precision, linearity | Recovery 90–110%; CV <10% | Four-parameter logistic curve fit |
| Antibodies | Titer, specificity, concentration, purity | Titer >512,000; >95% by SDS-PAGE | ELISA; A₂₈₀; SDS-PAGE densitometry |
| Assay kits | Standard curve R², blank OD, precision | R² >0.99; Blank <0.10 OD; CV <5% | Microplate reader |
| Small molecules | Purity, identity, moisture, heavy metals | ≥95–98%; NMR match; <0.5% H₂O; <10 ppm | HPLC; ¹H NMR; KF; ICP-MS |
| Buffers | pH, osmolality, sterility, endotoxin | ±0.1; ±5%; Sterile; <0.5 EU/mL | Meter; Osmometer; Filtration; LAL |
| Competent cells | Transformation efficiency, contamination | >10⁹ cfu/µg pUC19; No contamination | Plate counting; 3-day sterility test |
Sample COA Entry Format¶
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Certificate of Analysis
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Product: 2×Taq PCR Master Mix
SKU: PC1100 Lot: PC20240501
MFG Date: 2024-05-10 EXP Date: 2026-05-09
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Parameter Specification Result
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Appearance Clear, colorless Conforms
viscous liquid
pH 8.5 ± 0.5 8.7
Activity Amplify 1 kb target Cq = 18.2 ± 0.5
(50 ng gDNA)
DNase Not detectable <1 pg/reaction
RNase Not detectable <1 pg/reaction
Sterility No growth (14 d) No growth
Endotoxin <0.5 EU/mL 0.12 EU/mL
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QA Approval: __________________
Date: 2024-05-15
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How to Request a COA¶
COAs can be requested via four methods:
- Solarbio Store — Order history page: COA available as PDF download for each purchased lot
- Customer service email: Send product SKU and lot number to technical support
- Product packaging — QR code: Scan the QR code on the label to access COA via mobile browser
- Bulk order COA: Available on request for wholesale and institutional accounts
Typical Response Time¶
| Request Method | Response Time |
|---|---|
| Store download | Instant |
| QR code scan | Instant |
| Email request | Within 24 hours |
| Bulk order COA | Within 48 hours |
COA Verification¶
To verify the authenticity of any Solarbio COA:
- Check the lot number format: YYYYMMDD + product code
- Verify the COA QR code links to https://solarbio.store/coa/{lot-number}
- Confirm QA approval signature and date
- Compare physical product packaging lot number against COA lot number