Supporting Quality Assurance at Every Step of the Production Lifecycle
NJ Labs offers comprehensive Batch Release and Routine Testing services to help manufacturers maintain consistent product quality and meet strict regulatory expectations. Whether you’re preparing for a product launch, releasing raw materials, or conducting ongoing QC on finished products, our CGMP-compliant laboratory ensures accurate, audit-ready data that supports your quality systems.
We serve clients in pharmaceutical, nutraceutical, dietary supplement, cosmetic, and chemical industries, and are proud to be FDA and DEA-registered, and built on decades of trusted regulatory compliance.
Our Testing Services Cover the Full Product Lifecycle
Raw Material & Excipient Testing
- Identity testing (per USP <191>, <197>, <201>, etc.)
- Purity and composition
- Heavy metals and elemental impurities (USP <232> / <233>)
- Moisture content (Karl Fischer)
- Microbial limits (total aerobic count, yeast & mold, E. coli, Salmonella)
In-Process Testing
- Assay / potency checks using HPLC, UPLC, UV-Vis
- pH testing
- Titration-based quantification
- Disintegration / dissolution (for dosage forms)
Finished Product Testing
- Assay and active content uniformity
- Impurity and degradation profiling (ICH Q3A/Q3B)
- Microbiological testing (USP <61> / <62>)
- Residual solvent analysis (USP <467>) using GC Headspace
- Stability and shelf-life support testing
- Packaging component interaction testing
Elemental and Contaminant Testing
- ICP-MS for arsenic, cadmium, lead, mercury, and other metals
- Wet chemistry for nitrates, sulfates, peroxide value, acidity, etc.
- FTIR and UV-Vis for identification and purity testing
Instrumentation & Techniques We Use
We operate a full-service analytical chemistry and microbiology lab, including:
- High-Performance Liquid Chromatography (HPLC) – 5 Agilent 1100, 4 Agilent 1260 Infinity, Waters Alliance
- Ultra-Performance Liquid Chromatography (UPLC) – 2 Waters Acquity H-Class systems
- Gas Chromatography & Headspace (GC-HS) – Agilent 7890B, 8890, and G1888, 7697A Headspace
- Inductively Coupled Plasma Mass Spectrometry (ICP-MS) – Agilent 7800, 8900
- Karl Fischer Moisture Analysis
- FTIR and UV-Vis Spectroscopy
- CEM MARS 6 Microwave Digestion System for sample prep
- Refractive Index, Fluorescence, Thermal Conductivity & Flame Ionization Detectors
Results You Can Trust
With every test, we provide:
- Validated or verified methods (USP, EP, AOAC, in-house)
- Certificates of Analysis (COAs) with detailed data packages
- Data integrity compliant with 21 CFR Part 11 and CGMP
- Support for audit trails and submission readiness
Why Choose NJ Labs?
- Decades of regulatory experience
- Direct communication with technical staff
- Custom protocol development and method validation
- Rapid turnaround for production schedules
- Full traceability and documentation for every result
Your product’s reputation starts with its quality. NJ Labs ensures every batch released to market meets your internal specifications—and the standards your customers and regulators expect.
