SEP Analytical Labs
Where Precision Meets Purity
Rapid Results Testing
Rapid Microbiological Method (RMM)
Meet the requirements of USP while harnessing cutting-edge technology which allows for cost savings and speeds up the release of sterile preparations without sacrificing safety or reliability.
Microbiological Tests
Reliable & High-Quality
Accelerated Sterility Testing with Celsis®
At Sep Analytical Labs, we utilize the Celsis® rapid microbial detection system to provide fast and reliable sterility testing for pharmaceuticals, compounded preparations, and raw materials. Unlike traditional sterility testing, which takes 14 days, our Celsis ATP bioluminescence technology delivers results in just 4–5 days, helping you reduce production delays and improve efficiency while maintaining compliance with regulatory standards.
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Microbial Enumeration Tests
USP 61 assesses the total viable count of aerobic bacteria and fungi in non-sterile pharmaceutical products. It includes:
• Total Aerobic Microbial Count (TAMC)
• Total Yeast and Mold Count (TYMC)
These tests help determine microbial contamination levels and ensure compliance with microbial limits.
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Tests for Specified Microorganisms
USP 62 complements USP 61 by testing for specific objectionable microorganisms, including:
• Escherichia coli
• Salmonella species
• Staphylococcus aureus
• Pseudomonas aeruginosa
• Candida albicans
These tests ensure that harmful pathogens are absent in non-sterile pharmaceutical and personal care products.
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Endotoxin challenge Vials
At SEP Analytical Labs, we provide high-quality Endotoxin Challenge Vials (ECVs) to support the validation of your depyrogenation processes. Our ECVs are designed to help pharmaceutical, biotechnology, and laboratory facilities verify the effectiveness of their sterilization cycles and meet regulatory standards with confidence.
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Sterility Testing
Sep Analytical labs use ATP Bioluminescence for rapid detection of microbiological contaminants in compounded sterile preparations.
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Endotoxin Testing
Endotoxins are bacterial pyrogens, and include lipopolysaccharide (LPS) molecules found as part of the cell wall of gram negative bacteria.
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Method Suitability Testing
Sep Analytical labs perform Method Suitability testing, per our clients’ directions, for each new compound we receive to eliminate the chance…
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Antimicrobial Effectiveness Testing
USP 51 evaluates the effectiveness of preservatives in pharmaceuticals, cosmetics, and personal care products. This test ensures that antimicrobial preservatives effectively inhibit the growth of bacteria, yeast, and mold over a specified period.
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Analytical Tests
Reliable & High-Quality
Stability-Indicating Assay
At Sep Analytical labs, we specialize in Stability-Indicating Assays (SIA) to evaluate the potency and degradation profile of pharmaceutical products under various conditions. This critical analysis ensures your product maintains its efficacy, safety, and regulatory compliance throughout its shelf life.
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HPLC Method Development & Analysis
We develop and validate high-performance liquid chromatography (HPLC) methods tailored to your product’s analytical needs. Our HPLC services include impurity profiling, content uniformity, and stability studies.
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FTIR Analysis
At Sep Analytical Labs, we offer Fourier Transform Infrared (FTIR) Spectroscopy, a powerful analytical technique used to identify functional groups and verify the chemical composition of pharmaceutical, cosmetic, and industrial samples. This non-destructive method ensures material authenticity, purity, and compliance with industry standards.
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Potency Testing
Quantifies the active pharmaceutical ingredient (API) concentration to confirm product strength and compliance with regulatory specifications.
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pH Measurement
Critical for ensuring product stability and compatibility, our pH testing services support pharmaceutical formulations, cosmetics, and personal care products.
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Save Time Testing with our Rapid Detection Process.
Rapid Testing Results
SEP Analytical Labs LLC uses ATP Bioluminescence for rapid detection of microbiological contaminants in compounded sterile preparations
Stay USP Compliant
Meet the requirements of USP while harnessing cutting-edge technology which allows for cost savings and speeds up the release of sterile preparations without sacrificing safety or reliability..
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Now Offering Stability Studies
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