HPLC, ICP-MS, GC-MS, and LC-MS/MS testing with ICH Q2(R1)-validated methods, 48-hour turnaround, and pharma-grade documentation for supplements and FBA sellers.
IRVINE, CA, UNITED STATES, March 23, 2026 /EINPresswire.com/ — Qalitex Laboratories, an ISO 17025-accredited third-party testing laboratory serving dietary supplement and nutraceutical brands across North America, today outlined the analytical chemistry testing standards essential for substantiating label claims, meeting retailer quality audits, and preparing documentation for FDA cGMP compliance.
As regulatory and retailer scrutiny of the supplement industry intensifies, the standard for analytical testing has risen. Brands that once relied on basic identity testing now require validated HPLC methods, pharmaceutical-grade QC documentation, and results that can withstand FDA inspection. The distinction between validated and unvalidated analytical methods is critical — it determines whether test results are defensible in a regulatory context.
ICH Q2(R1) (Validation of Analytical Procedures: Text and Methodology) defines the parameters that analytical methods must meet to be considered fit for their intended purpose, including specificity, linearity, range, accuracy, precision, detection limit, and quantitation limit. Methods not validated to these standards may produce results that are not defensible under FDA scrutiny.
“The line between dietary supplements and nutraceuticals is blurring,” said Nour Abochama, Vice President of Operations at Qalitex Laboratories. “Brands are making increasingly specific potency claims that require pharmaceutical-grade analytical methods. We provide that level of rigor with industry-standard turnaround times. When a brand claims 500 mg of a specific active ingredient per serving, that claim must be backed by a validated HPLC method — not just a colorimetric assay.”
Qalitex’s analytical chemistry services include:
HPLC and UPLC identity and potency testing for vitamins, minerals, botanical actives, amino acids, and probiotics
ICP-MS heavy metal analysis per USP
GC-MS and LC-MS/MS pesticide residue testing per USP
FTIR and UV-Vis identification
Residual solvent testing per USP
Quantitative assays for active ingredients
Pharmaceutical QC testing, including dissolution per USP and content uniformity per USP
For brands targeting major retailers, Qalitex formats analytical documentation to meet specific supplier qualification programs, including Whole Foods Market, Target, and Costco. California-based nutraceutical companies must also comply with Proposition 65, requiring heavy metal testing documentation for products sold in the state.
“When evaluating a testing partner, brands should ask about method validation specifics,” said Abochama. “Which reference standard was used? What was the spike recovery for your matrix? What is the quantitation limit relative to your label claim? A qualified lab should answer these questions clearly. We work closely with new brands to ensure their testing aligns with both standard methods and unique product matrices.”
Resources:
Full article: https://qalitex.com/services/analytical-chemistry/
About Qalitex Laboratories
Qalitex Laboratories is an ISO 17025-accredited third-party analytical testing laboratory with facilities in Irvine and San Diego, California. The laboratory provides certificate of analysis (COA) testing, heavy metal analysis by ICP-MS, microbiology testing per USP and , preservative efficacy testing, stability studies under ICH guidelines, and regulatory compliance support for dietary supplement brands, cosmetic companies, and consumer goods manufacturers. Turnaround times start at 48 hours for standard panels. Testing programs meet 21 CFR Part 111, California Proposition 65, Amazon supplement compliance requirements, and Health Canada NHP Directorate standards.
Nour Abochama
Qalitex Laboratories
+ +1 949) 881-6661
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