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MICROBIOLOGICAL / STERILITY-GROWTH

Rapid growth-based sterility

Assess the submitted sample using a rapid growth-based sterility method. A typical 2–5 day growth cycle is separate from final report turnaround.

What’s included

Growth-based sterility

Method & scope

Full Sterility Analysis by Rapid Growth-Based Method, BacT/ALERT or equivalent. The requested scope is evaluated using BacT/ALERT or equivalent. Results apply to the submitted sample and the analysis performed.

Sample suitability & preparation

AV supports work involving APIs, lyophilized powders, capsule matrices, compounded products, and complex mixtures. Not every method is suitable for every matrix.

Sample quantity, containers, storage, handling, hazards, and acceptance requirements are confirmed by the laboratory during scope review. Send the product identity, matrix, label claims, and any supporting safety documentation with your request.

Your report

The authorized CoA identifies the sample, lot, covered tests, reported results and units, method references, and applicable limitations. Requested specifications are reviewed before acceptance; no unsupported pass/fail conclusion is implied.

Additional charges & limitations

Investigation, retesting, data packages, special reporting, and additional preparation may require a separate quote. Taxes and shipping are confirmed separately.

BUILD YOUR TESTING SCOPE

Your sample. Your selection.

Check the services you need. Uncheck any selection to remove it. Bundles already include the tests listed in their description.

Identity & purityEvaluate the identity and purity of the submitted API using liquid chromatography and mass spectrometry.+$170.00/ sampleIdentity, purity & contentCombine identity and purity testing with net API content for a more complete characterization of your submitted material.+$215.00/ sampleEndotoxin analysisEvaluate bacterial endotoxin in a submitted sample using a recombinant Factor C fluorescence assay. Matrix suitability requires laboratory review.+$125.00/ sampleHeavy metals panelAssess a 10-metal panel across Class 1, Class 2A, and Class 3. The specific analyte list and applicable scope will be confirmed by the laboratory.+$150.00/ sampleBundle ACoordinate API characterization and endotoxin testing in a single analytical request.+$315.00/ sampleBundle BExtend Bundle A with the heavy metals panel for a broader analytical scope.+$425.00/ sampleBundle CCombine Bundle A with full rapid growth-based sterility analysis. A typical 2 to 5 day growth cycle applies.Overlaps with your selection. Uncheck that service to switch.+$515.00/ sampleRapid growth-based sterilityAssess the submitted sample using a rapid growth-based sterility method. A typical 2–5 day growth cycle is separate from final report turnaround.$225.00/ sampleFull Panel ACombine chemical characterization, endotoxin, metals, and rapid growth-based sterility in one coordinated scope.Overlaps with your selection. Uncheck that service to switch.+$600.00/ sample90-day stabilityEvaluate a submitted sample over a 90-day study under ambient and extreme conditions. Sampling intervals, analytical scope, and reporting timing are confirmed with the laboratory.+$750.00/ sample180-day stabilityEvaluate a submitted sample over a 180-day study under ambient and extreme conditions. Sampling intervals, analytical scope, and reporting timing are confirmed with the laboratory.+$1,200.00/ sampleOsmolalityMeasure the total concentration of dissolved particles in a submitted solution. Sample suitability and reporting scope are confirmed by the laboratory.+$100.00/ sample

Selected analysis / sample$225.00

Continue with 1 service

Sample count and volume discounts are calculated in the next step. Preparation, shipping, tax and custom work are confirmed separately.

Questions about this analysis

AV Analytics provides analytical testing and reporting services only. Results are based solely on the submitted sample(s), requested scope of analysis, and methods performed. AV Analytics reports do not constitute or imply endorsement, approval, certification, validation, or guarantee of any product’s safety, efficacy, quality, regulatory compliance, marketability, or fitness for use unless otherwise stated in writing. Product safety, labeling, claims, regulatory compliance, release decisions, and use of analytical results remain solely the responsibility of the client or product sponsor.

PER-SAMPLE PRICING

$225.00Subject to acceptance

5–7 business days from sample acceptance

Typical growth cycle: 2–5 days. This is separate from final report turnaround.

Customize your scope New Client RequestRevised September 2026. Final scope and charges are confirmed at acceptance.

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