How Do I Get My Compounded Medication Tested?
Short answer
Contact an independent analytical lab that accepts samples from the public, tell it the product’s labeled ingredient, strength and dosage form, and submit a sample. The lab tests it, usually by HPLC, for identity and potency, and sends you a certificate of analysis. Renew Lab Group in Houston accepts samples from consumers, pharmacies and businesses; call 936-379-5515 to start.
Why people test compounded medications
Compounded medications are made by a pharmacy for an individual patient, so unlike FDA-approved drugs they are not reviewed by the FDA for quality before they are sold (FDA). In a limited FDA survey of compounded products ordered online, 34% failed at least one quality test, most often for being under strength (FDA). Testing tells you whether a product matches its label.
Step by step: getting a compounded medication tested
- Gather the details. Product name, labeled active ingredient and strength, dosage form (capsule, tablet, cream, solution), lot number and the pharmacy’s name if you have it.
- Contact the lab first. Call 936-379-5515, email info@renewlabgroup.com or use our contact form. We confirm whether we can test the product, which method we’ll use, the sample amount needed, the price and the turnaround.
- Submit the sample. Drop it off at our lab at 6001 Central Crest, Houston, TX 77092, or ship it using the instructions in your quote. Keep it in its original labeled container if you can.
- Analysis. We run the sample against a reference standard, typically by HPLC, and use LC-MS when identity confirmation or trace sensitivity is needed.
- Get your report. You receive a certificate of analysis with the result for each test.
What can be tested
| Test | What it tells you | Method |
|---|---|---|
| Identity | Is the labeled ingredient actually present? | HPLC retention time vs reference standard; LC-MS for mass confirmation |
| Potency | How much active ingredient is present, as a percent of label claim? | HPLC with a reference standard |
| Purity | Are there unexpected peaks, impurities or degradation products? | HPLC; LC-MS to identify unknowns |
Pharmacies and outsourcing facilities can also order endotoxin (LAL), microbiology and other tests; see our full lab testing services.
Reading your results
Potency is usually reported as a percentage of label claim. A capsule labeled 10 mg that measures 9.6 mg is 96% of label claim. Whether that passes depends on the product’s specification, and whether a product is right for you is a question for your pharmacist or prescriber. We report analytical facts and are happy to walk you through the report. If you believe a product harmed you, you can report it to the FDA through MedWatch.
Start testing
Individuals can read how it works on our pharmaceutical product testing for individuals page. Pharmacies should see potency and purity testing for compounding pharmacies. Learn about the method on our HPLC testing lab page.
Related questions
Do I need a doctor’s order to test a medication?
Product testing analyzes the product, not you. Requirements can vary, so call 936-379-5515 before sending a sample and we’ll tell you what we need.
How much does it cost to test a medication?
It depends on the tests and the product. For a quote, call 936-379-5515 or email info@renewlabgroup.com.
Can you tell me if my medication is safe to take?
No. We report what is in the sample and how much. Share the report with your pharmacist or prescriber for advice.
Is my information kept private?
Yes. Your identity, sample and results are confidential and shared only with you unless you authorize otherwise.
Talk to the lab about testing your medication
Tell us what you need tested and we’ll recommend a method and send a quote. Contact us at 936-379-5515 or info@renewlabgroup.com for current pricing, turnaround and sample requirements. Samples can be dropped off at our lab at 6001 Central Crest, Houston, TX 77092.
Sources
Researcher resources
- Shop Bacteriostatic and Sterile Water
- View Our Certificate of Analysis
- Free Reconstitution Calculator
- Compare BAC Water Products
Keep reading
- What Is a Beyond-Use Date (BUD)?
- Can You Use Tap Water in an Ultrasonic Diffuser?
- What Is ICP-MS Testing?
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