1. What types of testing services do you offer?
We provide a range of analytical services, including sterility testing, endotoxin testing, stability-indicating assays, potency testing, pH measurement, HPLC method development, HPLC analysis, and FTIR analysis.
2. Who can use your testing services?
Our services are available to pharmaceutical manufacturers, compounding pharmacies, research laboratories, medical device companies, and other regulated industries requiring analytical testing.
3. How do I submit a sample for testing?
You can submit samples through our online customer portal by filling out the required forms, making a payment, and printing the packing slip provided in your confirmation email.
4. How long does it take to receive results?
Turnaround time varies depending on the test: • Rapid sterility testing bioluminescence 5-7 days, Sterility Testing USP <71>: 14 days • Endotoxin Testing: 2-3 days • Potency and HPLC Analysis: 5-7 days Expedited options may be available upon request.
5. How will I receive my results?
Results are sent via email in PDF format. You will also receive updates on your sample status, including pictures, through our customer portal.
Sterility Testing
6. What is sterility testing, and why is it important?
Sterility testing ensures that a product is free from viable microorganisms. It is essential for sterile pharmaceuticals, compounded preparations, and medical devices to prevent infections and ensure patient safety.
7. What methods do you use for sterility testing?
We use the USP <71> membrane filtration and direct inoculation methods, depending on the sample type and regulatory requirements. In addition we use bioluminescence sterility testing
8. What types of samples require sterility testing?
• Injectable drugs • Ophthalmic solutions • Implantable medical devices • Parenteral nutrition solutions • Compounded sterile preparations
9. What sample volume is required for sterility testing?
The required volume depends on the formulation and container size. Generally, we require 10-20 mL per container, but specific guidelines apply based on USP regulations.
10. Can sterility testing be expedited?
Yes, sterility testing using bioluminescence takes 5-7 days.
Endotoxin Testing
11. What is endotoxin testing, and why is it necessary?
Endotoxin testing detects bacterial endotoxins (pyrogens) in sterile products. High endotoxin levels can cause severe reactions in patients, such as fever, shock, and organ failure.
12. What method do you use for endotoxin testing?
We use the USP <85> Limulus Amebocyte Lysate (LAL) test, including: • Gel clot method (pass/fail) • Kinetic turbidimetric method (quantitative) • Chromogenic method (high sensitivity)
13. What types of products require endotoxin testing?
• Injectable drugs • Dialysis fluids • Intravenous solutions • Ophthalmic solutions • Medical devices in direct contact with blood
14. What is the endotoxin limit for pharmaceuticals?
The limit varies by product type and route of administration. For example: • Injectables: ≤ 0.25 EU/mL • Intrathecal (spinal) drugs: ≤ 0.06 EU/mL • Medical devices: ≤ 20 EU/device
15. How should samples be prepared for endotoxin testing?
Samples should be sterile, free from preservatives or excipients that may interfere with the LAL reaction, and submitted in appropriate volumes (typically 1-5 mL per test).
16. How soon can I get my endotoxin test results?
Standard turnaround is 2-3 business days. Expedited testing (24-48 hours) may be available upon request.
Sample Submission & Logistics
17. How should I package my samples for shipping?
• Use leak-proof, sterile containers • Maintain cold chain storage (2-8°C) if required • Include the packing slip from your confirmation email • Use overnight shipping for sensitive samples
18. Do you accept international samples?
Yes, but clients must comply with shipping regulations and provide appropriate documentation for customs clearance.
19. Can I track my sample status?
Yes, you can track your sample’s progress in our customer portal, where you’ll receive status updates, including when testing begins and when results are ready.
Compliance & Quality Assurance
20. Are your tests compliant with regulatory standards?
Yes, our laboratory follows highest guidelines to ensure the highest quality and compliance.
21. Do you provide Certificates of Analysis (CoA)?
Yes, every test report includes a CoA detailing test results, methodology, and compliance information.
22. How do you ensure accuracy in your testing?
We use validated methods, regular proficiency testing, and strict quality control measures to maintain accuracy and reliability.
23. Do you store samples after testing?
Yes, we store tested samples for 15 days after results are issued. Additional storage options are available upon request.
24. Can you develop custom testing methods?
Yes, we offer method development and validation services for unique formulations and research projects.