A certificate of analysis is the lab report behind every vial. Here is how to read one line by line, and everything we test before a product carries your brand.
A COA is issued by a testing lab for one production lot. It lists every test that was run, the limit the product had to meet, and the result. If you put your name on a product, it is the document that backs it up.
Who issues it
An independent lab, separate from the company that makes or sells the product.
What it covers
Identity, strength, purity and a set of safety tests, each with its method, its limit and its result.
Why it matters to you
You and your clients can match the lot number on the vial to the report and see exactly what was tested.
Your Brand Here · Quality transparency
Certificate of Analysis, Explained
What an independent lab checks on every lot, in plain English, plus the lab detail medical directors look for.
Lot PBP-0000-00Specimen reportMultiple vials testedIndependent lab
1Hover a number on the report to see what it means.
Customer:Your Brand Here
Sample ID: SPEC-0000-000
Date Received: MM/DD/YYYY
Sample Name: Sample Peptide
Date Completed: MM/DD/YYYY
Sample Type: Powder
Lot No.: PBP-0000-00
Independent Testing Laboratory
Certificate of Analysis
Summary of Results
Analysis Type
Method
Date Tested
Status
Sample Peptide
HPLC
MM/DD/YYYY
Complete
Bacterial Endotoxins
USP <85>
MM/DD/YYYY
Complete
Sterility
qPCR
MM/DD/YYYY
Complete
Fentanyl
USP <2251>
MM/DD/YYYY
Complete
Residual Solvents
USP <467>
MM/DD/YYYY
Complete
Heavy Metals
ICP-MS
MM/DD/YYYY
Pass
Microbiological
Petrifilm/qPCR
MM/DD/YYYY
Pass
Label Claim Profile
Analyte
Result
Specification
LOD
Sample Peptide
Vial 1 = 10.40mg/vial
10mg/vial
0.01%
Sample Peptide
Vial 2 = 10.42mg/vial
10mg/vial
0.01%
Sample Peptide
Vial 3 = 10.37mg/vial
10mg/vial
0.01%
Identity of the analyte was confirmed by retention time concordance with a certified reference standard, per USP <621>.
Chromatographic Purity (3 Vials)
Vials 1,2,3 = >99%
>99%
0.01%
Bacterial Endotoxins (Gel-Clot: 1:10 Dilution)
<1.25 EU/ml
<5 EU/ml
λ = 0.125 EU/ml
Rapid Sterility (Real-Time qPCR) Validated per USP <1223> in lieu of USP <71>
No Microbial DNA/RNA Detected (Pass)
No Detection
10 CFU
Fentanyl (3 Vials)
Vials 1,2,3 = Not Detected
<LOD
10ppm
Acetone
<LOD
<5000ppm
500ppm
Acetonitrile
<LOD
<410ppm
50ppm
Benzene
<LOD
<2ppm
0.1ppm
Chloroform
<LOD
<60ppm
5ppm
Cyclohexane
<LOD
<3880ppm
50ppm
Methanol
<LOD
<3000ppm
50ppm
DMF (N,N-Dimethylformamide)
<LOD
<880ppm
50ppm
Dichloromethane (Methylene Chloride)
<LOD
<600ppm
50ppm
Diethyl Ether (Ethyl Ether)
<LOD
<5000ppm
500ppm
Isopropanol (2-Propanol)
<LOD
<5000ppm
500ppm
Hexanes
<LOD
<290ppm
5ppm
Ethanol
<LOD
<5000ppm
500ppm
THF (Tetrahydrofuran)
<LOD
<720ppm
50ppm
TFA (Trifluoroacetic acid)
<LOD
Report Only
50ppm
NOTES: Lyophilized samples may include acceptable salts, sugars, or buffering agents added to improve solubility and stability. These excipients are non-chromophoric, typically not detected by HPLC, and are not considered impurities. Three vials were independently tested to evaluate lot consistency and vial-to-vial variability.
LOD = LIMIT OF DETECTION; LOQ = LIMIT OF QUANTIFICATION
Independent Testing Laboratory
Laboratory name Street address City, State ZIP Accreditation no. on the original report
Laboratory DirectorSignature and date on the original report
The sample analyzed was inspected and showed no visual mold, mildew, or foreign matter. The presented report is only applicable to the sample specified above and may not be applied to any similar or identical products. Reports may not be reproduced with alterations of any kind.
Specimen
Customer:Your Brand Here
Sample ID: SPEC-0000-000
Date Received: MM/DD/YYYY
Sample Name: Sample Peptide
Date Completed: MM/DD/YYYY
Sample Type: Powder
Lot No.: PBP-0000-00
Independent Testing Laboratory
Certificate of Analysis
Heavy Metal Analysis (USP <233>)
Analyte
Result (mcg/vial)
LOQ (ppm)
LOD (ppm)
Limit (mcg/g)
Pass/Fail
Arsenic
<LOQ
0.010
0.005
0.5
Pass
Cadmium
<LOQ
0.010
0.005
0.1
Pass
Lead
<LOQ
0.010
0.005
0.5
Pass
Mercury
<LOQ
0.010
0.005
0.1
Pass
Microbiological Analysis (USP <61>, USP <62>)
Microbe
Result
Limit
Pass/Fail
Total Aerobic Plate
<10 CFU/g
<100 CFU/g
Pass
Coliform
<10 CFU/g
<10 CFU/g
Pass
Bile-Tolerant Gram-Negative Bacteria
<10 CFU/g
<10 CFU/g
Pass
Yeast and Mold
<10 CFU/g
<10 CFU/g
Pass
Escherichia Coli
Negative/1g
Negative/1g
Pass
Salmonella
Negative/1g
Negative/1g
Pass
Staphylococcus Aureus
Negative/1g
Negative/1g
Pass
NOTES: CFU = Colony Forming Unit; NS = Not Specified; NT = Not Tested. LOQ = Limit of Quantification; LOD = Limit of Detection.
Specimen
11 of 11
Specimen report for illustration. Values are examples from a single test and are not a claim about any product. Every lot has its own report from an independent lab, and the original, unaltered report is available on request.
Lot scorecard at a glance
Potency (label claim)10.37 to 10.42 mgspec 10 mg/vial
IdentityConfirmedvs. reference standard
Purity>99%spec >99%
Bacterial endotoxins<1.25 EU/mLspec <5 EU/mL
Sterility (qPCR)No detectionspec no detection
FentanylNot detected3 of 3 vials
Residual solvents15 of 15 <LODUSP <467>
Heavy metals4 of 4 <LOQUSP <233>
Microbiological7 of 7 passUSP <61>/<62>
LOD / LOQ
The smallest amount the lab can detect / reliably measure. "<LOD" means none was found.
EU
Endotoxin units, the standard measure of bacterial endotoxin.
CFU
Colony forming units, a count of living microbes.
USP
United States Pharmacopeia, the published standard methods labs follow.
Every test panel passed
7/7
Seven separate safety and quality tests were run on this lot, and every result landed inside the lab's specification.
The lab confirmed the peptide by matching it against a certified reference standard. Over 99% of what the instrument detected is the target peptide.
Lab detail Identity by HPLC retention time against a certified reference standard (USP <621>). Chromatographic purity above 99% on every vial tested.
No microbes detected
0
A DNA and RNA based test searched the sample for bacteria and fungi. Nothing was found.
Lab detail Rapid real-time qPCR sterility, validated per USP <1223> in lieu of USP <71>. Detection threshold 10 CFU.
No leftover solvents
15/15
Peptide manufacturing uses chemical solvents. All 15 tested, including benzene, came in below what the lab can detect.
Lab detail USP <467> panel including benzene, acetonitrile, dichloromethane, DMF, methanol, THF and TFA. All results <LOD.
Match this lot to your vial
Lot
A report applies to one lot only. The lot number printed on the vial should match the lot number on the report exactly.
Lab detail Check the sample ID, lot number, sample type and the received and completed dates. Every lot gets its own report.
Each vial meets its label
10.4 mg
Three vials labeled 10 mg each measured 10.37 to 10.42 mg. Every vial met or slightly exceeded its label claim.
Lab detail HPLC assay, n = 3. Mean 10.40 mg per vial (104% of label claim). Vial to vial spread 0.05 mg.
Endotoxin far below the limit
4x
Endotoxins are fragments of bacterial cell walls that labs measure in injectable products. This lot tested at least 4 times lower than the allowed limit.
Lab detail USP <85> gel clot at 1:10 dilution: <1.25 EU/mL against a specification of <5 EU/mL. Lysate sensitivity λ = 0.125 EU/mL.
Fentanyl screen: clear
ND
Each vial was screened on its own for fentanyl contamination. None was detected.
Lab detail USP <2251> adulterant screening, 3 vials, all Not Detected. Limit of detection 10 ppm.
Signed by an independent lab
Lab
The report is issued and signed by an outside laboratory, not by the supplier. Look for the lab's details, its accreditation and a signature on every report.
Lab detail Testing labs are commonly accredited to ISO/IEC 17025, the international standard for testing and calibration laboratories. The original, unaltered report is the governing document.
Heavy metals: too low to measure
4/4
Arsenic, cadmium, lead and mercury were each below the smallest amount the lab's instrument can reliably measure.
Lab detail USP <233> by ICP-MS. All results <LOQ (0.010 ppm; LOD 0.005 ppm). Limits: arsenic and lead 0.5 mcg/g, cadmium and mercury 0.1 mcg/g.
No harmful bacteria, yeast or mold
7/7
No E. coli, Salmonella or Staph was found. Total bacteria, coliforms, yeast and mold were all under 10 CFU per gram.
Lab detail USP <61>/<62>. Total aerobic count <10 CFU/g (limit <100). Coliforms, bile-tolerant gram-negative bacteria, yeast and mold <10 CFU/g. Pathogens negative per 1 g.
What a purity result is based on
HPLC separates a sample into its parts over time, and each part shows up as a peak. The compound on your label should be one tall peak, with little else around it.
Figure 1. Example HPLC chromatogram, for illustration. The shaded area under the main peak is what the purity result measures.
Purity (%) = area of the main peak ÷ total area of all peaks × 100A good report shows the chromatogram next to the number, so you can see the peaks instead of taking a percentage on trust.
What we test, and why
Every report covers a full panel, run on multiple vials from the lot. Each test answers one plain question about the product you will put your name on.
Test
The question it answers
Method
Identity and strength
Identity
Is this the compound on the label?
HPLC against a certified reference standard (USP <621>)
Label claim
Does each vial hold the amount it says?
HPLC assay on multiple vials
Purity
How much of the sample is the target compound?
HPLC-UV, with chromatogram
Microbial safety
Bacterial endotoxins
Are toxins left by bacteria within limits?
Gel-clot LAL (USP <85>)
Sterility
Is there any live microbial contamination?
Rapid qPCR (USP <1223>)
Microbial limits
Are bacteria, yeast and mold within limits?
USP <61> and <62>
Contaminants
Heavy metals
Are lead, arsenic, mercury and cadmium within limits?
ICP-MS (USP <233>)
Residual solvents
Are any solvents left over from manufacturing?
Gas chromatography (USP <467>)
Contaminant screen
Has anything dangerous from the wider supply chain made it into the vial?
LC-MS (USP <2251>)
How our COA compares with a basic one
A basic COA confirms what the product is and how pure it is. That is a good start. Your clients also deserve to know what is not in the vial.
On the report
Basic COA
Our partner COA
Identity
Yes
Yes
Purity by HPLC
Yes
Yes, with chromatogram
Label claim, measured per vial
Not always
Yes
Multiple vials tested per lot
Not always
Yes
Endotoxins and sterility
Not always
Yes
Heavy metals and residual solvents
Not always
Yes
Microbial limits and contaminant screen
Not always
Yes
Independent accredited lab
Not always
Yes
From lot to report
The same lot number follows your product from production to your shelf, so every vial can be traced to its report.
The lot is made
Every production run gets its own lot number, printed on each vial and box.
Samples go to an independent lab
Vials are pulled from the lot and tested for the full panel.
The lab issues the report
Method, limit and result for each test, signed by the lab.
You receive the COA for your lot
Matched to the lot you receive, for your records and your clients.
COA questions
What is a certificate of analysis (COA)?
A COA is a lab report for one production lot. It lists each test run on the product, the method used, the limit the product had to meet and the actual result.
Who performs the testing?
An independent third-party lab that is separate from us and from the manufacturer.
Do I get a COA for every lot I order?
Yes. Each lot has its own report, and the lot number on your vials matches the report you receive.
Why test more than one vial?
One vial shows that one vial passed. Several vials from the same lot show the whole batch is consistent, from the first vial filled to the last.
What does "contaminant screen" mean?
It is a test for dangerous adulterants that have turned up in parts of the wider supply chain, including synthetic opioids. It is a routine safety check, and the result reads "Not detected" when nothing is found.
What do "< LOD" and "EU/mL" mean?
"< LOD" means below the limit of detection: the substance was not found at the lowest level the instrument can measure. "EU/mL" is endotoxin units per milliliter, the standard measure for bacterial endotoxins.
Can I share COAs with my own clients?
Partners can share the COA for the lot they sell so their clients can see exactly what was tested.
Request a sample COA
Our Business Development Team will send a complete sample report and walk you through it line by line. Every partner gets one dedicated contact from day one.
