HPLC Laboratory & Comprehensive Pharmaceutical Testing Services
Renew Lab Group operates one of America’s most advanced HPLC (High-Performance Liquid Chromatography) testing laboratories, delivering certified pharmaceutical-grade analysis for compounding pharmacies, biotech firms, research institutions, and clinical organizations across all 50 U.S. states. Our ISO 5/7-aligned cleanroom facility in Houston, TX combines decades of analytical chemistry expertise with cutting-edge instrumentation to provide results you can stake your reputation on.
What Is HPLC Testing — And Why Does It Matter?
High-Performance Liquid Chromatography (HPLC) is the gold standard analytical method used in pharmaceutical manufacturing and research laboratories worldwide to separate, identify, and quantify chemical compounds in a sample. Unlike simpler visual or wet-chemistry tests, HPLC provides exact purity percentages, impurity profiles, and concentration data at parts-per-million sensitivity — making it indispensable for USP pharmaceutical water testing, peptide verification, API analysis, and regulatory compliance.
Our Complete Testing Services
1. Pharmaceutical Water Purity Testing
We test all categories of pharmaceutical water per USP <1231> and EP standards, including Purified Water (PW), Water for Injection (WFI), Bacteriostatic Water for Injection (BWFI), and Sterile Water for Irrigation. Testing panels include: TOC, conductivity, pH, endotoxin (LAL), microbial limits, heavy metals (ICP-MS), HPLC purity profiling, and benzyl alcohol quantification.
2. Endotoxin & Pyrogen Testing (LAL)
Our limulus amebocyte lysate (LAL) endotoxin testing meets USP <85> specifications, providing quantitative endotoxin burden results with detection limits below 0.005 EU/mL. All Renew Lab Group products carry endotoxin levels below the industry standard of 0.25 EU/mL — industry-leading purity for compounding and research applications.
3. Peptide Purity & Identity Analysis
Our reverse-phase HPLC (RP-HPLC) platform quantifies peptide purity with accuracy exceeding 99.5%, identifying degradation products, racemization, and sequence variants. We work with GLP-1 agonists, research peptides, BPC-157, TB-500, and custom synthesized sequences. Results include a Certificate of Analysis with retention time data, peak area percentages, and mass spectrometry confirmation.
4. Active Pharmaceutical Ingredient (API) Potency Testing
Quantitative HPLC potency assays confirm label claim accuracy for APIs including semaglutide, tirzepatide, NAD+, vitamin C, amino acids, and compounded preparations. Our validated analytical methods comply with FDA 21 CFR Part 211 and USP General Chapter <621> requirements.
5. Microbiological Testing
Comprehensive microbiological panels include total aerobic microbial count (TAMC), total yeast and mold count (TYMC), USP <71> sterility testing, bioburden assessment, and specified organism testing (E. coli, Salmonella, S. aureus, P. aeruginosa). Our environmental monitoring program maintains ISO 5/ISO 7 cleanroom compliance continuously.
6. Heavy Metals & Elemental Impurity Analysis (ICP-MS)
Inductively coupled plasma mass spectrometry (ICP-MS) provides ultra-trace elemental analysis per ICH Q3D and USP <232>/<233> for oral, parenteral, and inhalation products. We screen for all 24 elemental impurities including lead, arsenic, mercury, cadmium, and platinum-group metals at sub-ppb detection limits.
7. Benzyl Alcohol Quantification
Precise benzyl alcohol (BA) content verification in bacteriostatic water for injection using validated RP-HPLC methods. Our standard bacteriostatic water formulation contains 0.9% benzyl alcohol as a confirmed antimicrobial preservative — precisely quantified in every batch with a documented Certificate of Analysis.
8. TOC (Total Organic Carbon) Analysis
Online and offline TOC analysis per USP <643> for pharmaceutical water systems, validating water purification system performance and detecting organic contamination at parts-per-billion levels.
9. Stability & Shelf-Life Studies
ICH Q1A-compliant accelerated and real-time stability programs for pharmaceutical waters, injectables, and compounded preparations. We provide forced degradation studies, photostability testing, and beyond-use date (BUD) validation studies with comprehensive statistical data analysis per USP <1150> and USP <1160>.
10. Container Closure & Extractables/Leachables
Evaluation of packaging materials for compatibility with pharmaceutical liquids, quantifying extractables and leachables per ICH Q3E guidelines. Critical for vials, syringes, IV bags, and multi-dose containers.
Industries We Serve Nationwide
Our lab testing services support organizations across the U.S. healthcare and life sciences ecosystem, including compounding pharmacies (503A and 503B), biotech and pharmaceutical R&D, clinical research organizations (CROs), academic research institutions, medical device manufacturers, nutraceutical companies, and veterinary compounders — all requiring COA-backed pharmaceutical testing services.
Regulatory Compliance & Certifications
Our laboratory operates under cGMP principles with documented SOPs, training records, calibration programs, and change control systems meeting FDA 21 CFR Part 211, USP Chapters <621>, <643>, <71>, <85>, <232>, <1231>, ICH Q1A, Q3D, Q3E, and ISO 9001:2015 Quality Management System standards.
Frequently Asked Questions
What is the difference between HPLC and UPLC testing?
HPLC uses particle sizes of 3-5 micrometers, while UPLC uses sub-2-micrometer particles for faster, higher-resolution separations. Both provide equivalent regulatory acceptance. Renew Lab Group uses both technologies, selecting the optimal platform for each analysis.
Do you provide Certificates of Analysis (COA) with all testing?
Yes. Every product and testing service from Renew Lab Group includes a fully documented Certificate of Analysis with method references, instrument serial numbers, analyst signatures, and numerical results. Our COAs meet compounding pharmacy board requirements and FDA inspection expectations.
How quickly can you process samples?
Standard turnaround time is 3-5 business days from sample receipt. Expedited service (24-48 hours) is available for most testing panels. For ongoing relationships, we offer dedicated capacity with guaranteed turnaround commitments.
