Certificates of Analysis
Purity you can verify. Every BioPure batch is made to grade and documented — here is what we test for, what our certifications mean, and how to get the Certificate of Analysis for your product.
What is a Certificate of Analysis?
A Certificate of Analysis, or COA, is a document that reports the results of the quality and safety testing performed on a specific batch of a product. It is not a logo or a marketing badge — it is the underlying data: the measured results that show a batch met its specification before it was released.
For a product like ours, a COA is how a claim on the label becomes something you can actually check. It ties the material in your hand to a documented set of results, recorded against the lot or batch number printed on your bottle.
- The product and the specific lot or batch it describes
- Identity — confirmation the material is what the label claims
- Purity and strength against the product's specification
- Contaminant and heavy-metal screening results
- The specification each result is measured against
We keep specifics factual: exact figures, ranges, and the testing laboratory are recorded on the COA for each batch rather than summarized here, so what you read always matches the lot you received.
Checked from the source to the seal.
Quality starts with the raw material and is documented through to a finished, filled bottle. Each batch is assessed across the areas that matter most for a product made to a clinical standard.
Identity
Confirmation that the material in the bottle is exactly what the label says it is — verified against a reference standard before it is ever filled.
Purity & strength
Analysis of concentration and composition so the solution matches its stated specification — for example, our 2% Methylene Blue delivering an accurate 1 mg per drop.
Contaminants
Screening for impurities and residues that do not belong, so what reaches you is clean, consistent, and made to grade.
Heavy metals
Testing against USP limits for the heavy metals of primary concern — arsenic, cadmium, lead, and mercury — for added assurance.
Microbial safety
Where applicable, checks for microbial contamination so each batch meets its safety specification before release.
Lot traceability
Every result is tied to a specific production lot or batch, printed on your bottle — so a COA reflects the exact material you hold.
What our marks mean.
USP-grade speaks to the material and how it is verified; GMP and FDA-registered speak to the facility and controls behind every batch. Together they are the standard a COA is written against.
Grade certified
USP-grade material, tested free from contaminants and heavy metals.
Compliant facility
Produced under Good Manufacturing Practices and documented controls.
Registered facility
Manufactured in an FDA-registered, USP facility held to rigorous standards.
Made in Canada
Every BioPure product is proudly manufactured in Canada.
USP-grade refers to material meeting United States Pharmacopeia standards. “GMP” refers to Good Manufacturing Practices. Facility registrations and any independent accreditations are documented by the manufacturer; see Our Standards for more.
From grade to certificate.
A COA is the last word in a process built around consistency. Each step is controlled and documented so the certificate reflects the exact material you receive — batch after batch.
- 01
Sourced to grade
We accept only USP-grade material, certified and screened at the source to be free from contaminants and heavy metals before it enters production.
- 02
Tested & documented
Each batch is assessed for identity, purity, and safety under our facility's quality controls, and the results are recorded against that specific lot.
- 03
Released to specification
A batch is released only once its results meet specification. The Certificate of Analysis captures those results for the lot you receive.
Request the results for your product.
Certificates of Analysis are available on request. Send us your product and the lot or batch number printed on the bottle, and we will provide the corresponding COA.
Contact us for your COA
The fastest way today. Include the product name and the lot or batch number from your bottle so we can match your exact batch. We typically reply within a business day or two.
- 1Find the lot or batch number printed on your product label.
- 2Note the product name and, if you have it, your order number.
- 3Send it to us through the contact page and we will send the COA.
Self-serve lot / batch lookup
We are building a searchable library so you can pull the COA for any lot in seconds. This is a preview of that experience — the search is not active yet. For now, please use the request option.
Placeholder preview pending live COA assets and lookup infrastructure. The lot-number format shown is illustrative only.
Quality at a glance.
A summary of what each product is made to. Exact measured results, ranges, and the testing laboratory appear on the batch COA for your specific lot.
Methylene Blue
- Grade
- USP grade
- Concentration
- 2% solution · 1 mg per drop
- Identity
- Confirmed against reference
- Alcohol
- Alcohol-free
- Heavy metals
- Meets USP limits — see COA
- Lot / batch
- Printed on your bottle
Bacteriostatic Water
- Format
- 30 mL multidose
- Preservative
- 0.9% benzyl alcohol
- Materials
- Latex-free
- Microbial
- Meets specification — see COA
- Label note
- Not for use in newborns
- Lot / batch
- Printed on your bottle
Values shown describe each product’s specification and are pending confirmation against the client’s live COA documents. Bacteriostatic Water is labeled not for use in newborns.
Questions about our COAs.
Request the Certificate of Analysis for your batch.
Have your product and lot number ready and we will send the results. Prefer the bigger picture first? Read about our standards, or browse the catalog.