Lot 005-2026
Quick Laboratory Summary
A concise overview of the reported laboratory results for the current production lot.
- Lot identification
- Selected reported results
- Testing summary
- Suitable for quick review
Independent Testing & COAs
BAC Colombia Product Documentation
Independent Laboratory Testing & Certificates of Analysis
BAC Colombia publishes lot-specific laboratory documentation for its bacteriostatic water products. Representative samples from each production lot are submitted to an independent third-party laboratory for analytical and microbiological testing before the lot is released for sale.
Every new production lot receives its own supporting documentation. As new lots become available, this page is updated with the corresponding results, Certificates of Analysis, and laboratory reports.
Current Production Lot
Lot 005-2026
The documentation for this production lot applies to BAC Colombia 3 mL, 10 mL, and 30 mL presentations filled from the same production lot.
Released
Testing
Independent third-party laboratory
Documentation
Publicly available
Products Covered
3 mL, 10 mL and 30 mL
Lot 005-2026
Laboratory Results Summary
The following summary presents selected results reported for representative samples from Lot 005-2026. Complete supporting documentation is available in the full laboratory file.
| Test | Method / Reference | Reported Result | Laboratory Status |
|---|---|---|---|
| Appearance | Visual Evaluation | Clear, Colorless | Within Reported Specification |
| pH | Instrumental pH Measurement | 6.87 | Within Reported Specification |
| Benzyl Alcohol Quantification | HPLC | 9.48 mg/mL | Within Reported Specification |
| Sterility Test | USP <71> | No Growth Detected | Passed |
| Bacterial Endotoxins | USP <85> | <1 EU/mL | Passed |
| Elemental Impurities | USP <232> / ICP-OES | Within Reported Acceptance Criteria | Passed |
This table is a summary only. Analytical reports, chromatograms, calibration data, microbiological records, and supporting laboratory documentation are included in the complete laboratory file.
Public Documentation
Download Laboratory Documentation
BAC Colombia publishes both a concise summary and the complete supporting laboratory file for the current production lot. The full file includes the analytical records provided with the laboratory review of Lot 005-2026.
PDF
Lot 005-2026
Complete Laboratory File
The full documentation package supporting the analytical and microbiological review of the current production lot.
- Laboratory summary
- Analytical reports
- Chromatograms and calibration records
- Microbiological testing
- Supporting laboratory documentation
Independent Verification
Why Independent Testing Matters
Independent testing adds a separate layer of review beyond internal production records. Representative samples are submitted to an external laboratory so that reported characteristics can be assessed using documented analytical and microbiological methods.
Publishing the resulting reports allows customers, researchers, institutions, and procurement teams to review the same lot-specific information used to support the release of each BAC Colombia production batch.
Testing Overview
Understanding the Testing Program
Each test contributes a different piece of information about the reported characteristics of the production lot. The sections below explain the purpose of the principal tests included in the current laboratory documentation.
Appearance
Appearance testing is a visual evaluation of the submitted sample. The report for Lot 005-2026 describes the sample as clear and colorless.
pH Measurement
pH testing measures the acidity or alkalinity of the submitted sample. Lot 005-2026 reported a measured pH of 6.87.
Benzyl Alcohol Quantification
High-performance liquid chromatography (HPLC) was used to quantify benzyl alcohol in the submitted sample. Lot 005-2026 reported a measured concentration of 9.48 mg/mL.
Sterility Test
Sterility testing evaluates submitted samples for detectable viable microbial growth under the conditions described in USP Chapter <71>. The report for Lot 005-2026 states no growth detected.
Bacterial Endotoxins
Bacterial endotoxin testing measures endotoxin levels in the submitted sample using the laboratory method referenced to USP Chapter <85>. Lot 005-2026 reported a result below 1 EU/mL.
Elemental Impurities
Elemental analysis examines the submitted sample for selected elements using instrumental methods such as ICP-OES. The laboratory report states that Lot 005-2026 met the reported acceptance criteria for the tested elements.
Batch-Level Testing Across All Three Presentations
The laboratory documentation for Lot 005-2026 applies to BAC Colombia 3 mL, 10 mL, and 30 mL presentations filled from the same production lot.
Testing is performed at the production-lot level using representative samples. Individual vial sizes are not tested as separate production lots when they originate from the same batch.
Frequently Asked Questions
Questions About Testing and COAs
The answers below explain how BAC Colombia organizes, publishes, and updates its lot-specific laboratory documentation.
Is every BAC Colombia production lot independently tested?
BAC Colombia’s testing program is structured around lot-specific third-party laboratory analysis. Each released production lot receives its own supporting documentation.
What is a Certificate of Analysis?
A Certificate of Analysis, commonly called a COA, is a document that summarizes reported test results for a specific sample or production lot. It should be reviewed together with the applicable test methods, specifications, and supporting laboratory reports.
Why does one report apply to the 3 mL, 10 mL, and 30 mL presentations?
The three presentations are covered by the same documentation when they are filled from the same production lot. Testing is performed at the lot level using representative samples rather than treating each vial size as a separate batch.
Why is batch-level testing used?
Batch-level testing allows the reported analytical results to be tied to a specific production lot. Products originating from that lot can then be identified through the corresponding lot number and documentation.
Who performs the laboratory testing?
The published documents identify the independent laboratory responsible for the reported testing. BAC Colombia provides the original supporting documentation received for the applicable production lot.
Can customers review the complete laboratory file?
Yes. BAC Colombia publishes both a quick summary and the complete available laboratory file for the current production lot.
Are chromatograms and calibration records included?
The complete file for Lot 005-2026 includes analytical reports and supporting records such as chromatograms, calibration information, and microbiological documentation where provided by the laboratory.
What does USP <71> refer to?
USP <71> refers to a United States Pharmacopeia chapter describing sterility test procedures. Referencing a USP chapter identifies the reported test method; it does not by itself indicate regulatory approval of a product.
What does USP <85> refer to?
USP <85> refers to bacterial endotoxin testing procedures described by the United States Pharmacopeia. The current report lists the method used and the result reported for Lot 005-2026.
What is HPLC?
High-performance liquid chromatography is an analytical technique used to separate, identify, and quantify compounds in a sample. The current documentation reports HPLC testing for benzyl alcohol quantification.
What is ICP-OES?
Inductively coupled plasma optical emission spectrometry is an instrumental technique used to measure selected elements in a sample. The full documentation identifies the reported elemental testing performed for the current lot.
Will future production lots receive new documentation?
Yes. As new production lots are released, BAC Colombia updates this page with the corresponding lot information and available supporting documents.
Does a passing laboratory result mean the product is approved for human use?
No. Laboratory results describe the submitted sample and the reported test outcomes. They do not constitute regulatory authorization or approval for human or veterinary use.
Documentation Philosophy
Our Commitment to Transparency
BAC Colombia believes customers should be able to review meaningful lot-specific documentation rather than rely only on general quality statements.
For this reason, we publish the current lot number, selected laboratory results, a concise summary, and the complete available supporting file. This allows visitors to review both the reported conclusions and the underlying documentation.
The documentation is updated when a new production lot becomes available so that product information remains connected to the applicable batch.
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Related Product and Policy Information
BAC Colombia Products
View available 3 mL, 10 mL, and 30 mL presentations.
Shipping & Delivery
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Product Disclaimer
Read important Research Use Only and regulatory information.
Contact BAC Colombia
Contact our team with questions about products or documentation.
Product and Regulatory Notice: BAC Colombia products are offered for Research Use Only (RUO). The laboratory documentation published on this page is provided for transparency, product information, and lot-specific quality verification. Laboratory results relate to the submitted samples and do not constitute regulatory authorization, approval for human or veterinary use, or evidence of therapeutic suitability. BAC Colombia products offered for Research Use Only are not approved by INVIMA for human use.