What is OROS Reconstitution Solution intended for?
OROS Reconstitution Solution is intended strictly for research use only. It is not intended for human or animal consumption, medical use, diagnostic use, cosmetic use, or injection.
This product is a sterile, benzyl alcohol-preserved water solution designed for the reconstitution of lyophilized materials in a controlled research setting.
What is in OROS Reconstitution Solution?
OROS Reconstitution Solution is a sterile water-based solution preserved with 0.9% benzyl alcohol. Benzyl alcohol is included as a preservative to support the integrity of the solution after opening in appropriate research workflows.
How is OROS Reconstitution Solution tested?
Every batch is independently third-party tested in the United States for benzyl alcohol content, pH, endotoxins, microbial contamination, heavy metals, and multi-vial variance.
This testing framework helps verify preservative content, solution consistency, cleanliness, contaminant control, and batch-to-batch uniformity before release.
Why do you test for benzyl alcohol content?
Benzyl alcohol content testing confirms the presence of benzyl alcohol and verifies that the solution meets its labeled 0.9% benzyl alcohol claim.
This is an important quality-control step because preservative concentration can affect consistency and performance in research reconstitution workflows. We test to confirm the preservative level is aligned with the product specification before release.
Why do you test pH?
pH testing measures the acidity or alkalinity of the finished solution. This helps confirm that each batch is consistent with expected formulation specifications and supports batch-level quality control.
Because Reconstitution Solution is used with lyophilized research materials, pH consistency is an important part of maintaining a controlled and predictable research preparation environment.
What are endotoxins, and why test for them?
Endotoxins are bacterial byproducts that may remain even when a solution appears clear and visually acceptable. Endotoxin testing helps provide additional insight into cleanliness and batch-level quality control.
Because Reconstitution Solution is used to prepare lyophilized materials in a research setting, we believe endotoxin testing is an important part of verifying the quality and consistency of the finished solution.
Why do you test for microbial contamination?
Microbial testing helps verify that the finished solution meets microbiological quality expectations. This screening evaluates unwanted microbial presence that may indicate poor manufacturing, handling, packaging, or storage conditions.
We believe microbial testing is essential for a sterile water-based solution because it helps confirm the product is manufactured and handled under controlled quality processes.
Why do you test for heavy metals?
Heavy metals such as lead, arsenic, cadmium, and mercury can be introduced through raw materials, water sources, equipment, or manufacturing environments.
Heavy metal screening helps verify that elemental impurities remain within established specifications and supports overall contaminant control.
What is multi-vial variance testing?
Multi-vial variance testing evaluates multiple vials from the same batch to help confirm consistency across the lot.
For Reconstitution Solution, this helps verify that finished vials are uniform in key quality attributes such as preservative content, pH, and overall batch consistency.
Who performs your testing?
As of April 2026, all new OROS Reconstitution Solution batches are tested by independent ISO/IEC 17025-accredited laboratories in the United States. ISO 17025 is an internationally recognized quality standard for testing and calibration laboratories that helps support analytical accuracy, method validation, reproducibility, traceability, and quality control.
We believe utilizing accredited third-party laboratories provides an additional level of transparency and confidence in our testing program by ensuring analytical results are generated under established and independently audited quality systems.
Where can I find the Certificate of Analysis (COA)?
COA reports are available on each product page within the product image gallery. Current and previous batch information—including lot numbers, manufacturing dates, expiration dates, and testing documentation—can also be found on our Lab Results Page.
Is this product made in the USA?
OROS Reconstitution Solution is manufactured in the USA through qualified third-party manufacturing partners operating under controlled quality processes. All analytical testing is conducted in the United States by independent laboratories.
What matters most is that finished batches undergo analytical verification before release, including preservative content, pH, endotoxins, microbial contamination, heavy metals, and multi-vial variance.
How is it shipped?
All orders are shipped from our North Carolina via UPS, with your choice of Ground, 2-Day, or Express services. Orders over $150 receive free UPS 2-Day shipping. Every order includes full shipment insurance at no additional cost.
Do you ship with cold packs or temperature control?
No. OROS Reconstitution Solution does not require cold-chain shipping or cold packs during standard transit windows.
Short-term temperature fluctuations that may occur during normal shipping and final-mile delivery are not expected to compromise the product when it is stored properly after receipt.
For best results, store the product according to the storage guidance listed on the label and avoid prolonged exposure to excessive heat, direct sunlight, or freezing conditions.
Where do you ship?
We currently ship to U.S. addresses only. We do not ship to PO Boxes, international destinations, military bases, or U.S. territories.
What payment methods do you accept?
We accept all major debit and credit cards, including American Express. HSAs and FSAs are not accepted.
After checkout, you must complete our secure Payment Authorization Form. Orders are not processed or shipped until authorization is completed. This workflow ensures PCI compliance and protects your payment data.
Do you accept returns?
All sales are final. If an issue occurs with your order, please contact support@orosresearch.com within 7 days of delivery.
How should this product be stored?
Store Reconstitution Solution in a cool, dry environment away from direct sunlight, excessive heat, and freezing conditions. Keep the vial sealed until ready for use in a research setting.
Looking for more answers?
Visit our Full FAQ Page for detailed information on storage, COAs, policies, and additional support.
