From raw materials and APIs to excipients and finished pharmaceutical products, NJ Labs provides analytical and microbiological testing to help pharmaceutical manufacturers verify quality, meet specifications, and support regulatory requirements.
With more than 90 years of analytical testing experience, NJ Labs is an FDA-registered, DEA-registered laboratory operating under cGMP-compliant quality systems. We support USP, EP, BP, and JP methods, along with specialized testing for elemental impurities, residual solvents, amino acids, microbiology, and more.
NJ Labs performs pharmaceutical testing across the full range of material and product types encountered in pharmaceutical manufacturing and quality control programs.
| Material / Product Type | Testing Applications | Applicable Standards |
|---|---|---|
| Raw materials | Identity, purity, assay, microbial limits, residual solvents, elemental impurities, moisture, physical characterization | USP, EP, BP, JP individual monographs; ICH Q3C, Q3D |
| Active pharmaceutical ingredients (APIs) | Identity, assay, related substances, residual solvents, elemental impurities, optical rotation, microbial limits | USP, EP, BP, JP monographs; ICH Q3A, Q3C, Q3D; NDA/ANDA/DMF support |
| Excipients | Identity, purity, assay, microbial limits, endotoxin, residual solvents, elemental impurities, physical characterization | USP/NF excipient monographs; EP, BP, JP; IPEC-PQG specifications |
| Finished pharmaceutical products | Assay, dissolution, disintegration, uniformity of dosage units, impurity profiling, microbial limits, preservative efficacy, sterility | USP, EP, BP, JP product monographs; 21 CFR Part 211; NDA/ANDA batch release |
| Pharmaceutical water | Total organic carbon, water conductivity, microbial limits, endotoxin | USP <643>, USP <645>, USP <61>, USP <85>, USP <1231> |
Incoming material testing is a CGMP requirement under 21 CFR 211.84 and one of the most effective upstream quality controls available to pharmaceutical manufacturers. NJ Labs performs identity, assay, purity, impurity, microbial limits, elemental impurity, residual solvents, moisture, physical characterization, and optical rotation testing for pharmaceutical raw materials, APIs, and excipients against applicable USP, EP, BP, JP, and internal specifications.
NJ Labs performs pharmaceutical product testing for solid, semi-solid, liquid, and sterile dosage forms. Testing includes assay, dissolution, disintegration, content uniformity, impurity and degradation product evaluation, microbial limits, sterility, preservative efficacy, bacterial endotoxin, and physical tests against applicable compendial and product-specific specifications to support batch release and regulatory submissions.
NJ Labs maintains specialized analytical instrumentation and procedures for testing requirements beyond routine compendial analysis. Key specialized services include:
NJ Labs uses ICP-MS to detect and quantify elemental impurities in pharmaceutical materials and products at ppb and ppt levels per USP <232> and <233>, aligned with ICH Q3D. Elements evaluated include lead, arsenic, cadmium, mercury, and other ICH Q3D target elements.
NJ Labs performs Ninhydrin Positive Substances and ammonium limit testing using a bioinert UPLC system with post-column ninhydrin derivatization.
High-Performance Thin-Layer Chromatography (HPTLC) combined with ATR-FTIR spectroscopy supports identification, separation, and impurity testing in pharmaceutical formulations – particularly for botanical and natural-source materials.
TOC testing per USP <643> monitors organic contamination in pharmaceutical water systems including Purified Water and Water for Injection and supports cleaning validation programs.
Water activity (aw) testing per USP <922> supports formulation development, packaging selection, stability programs, and storage condition decisions for pharmaceutical materials and products.
Limit of methanol testing in dehydrated alcohol per current USP monographs supports compliance for pharmaceutical alcohol used in sanitizers, medical wipes, and excipient applications.
NJ Labs performs bacteriostasis and fungistasis testing per USP <51>, <61>, <62>, and <71> to confirm that products with antimicrobial properties do not interfere with microbial recovery during sterility, microbial limits, or preservative efficacy testing. Fatty acid profile analysis for pharmaceutical oils is also available.
NJ Labs performs compendial testing under all four major international pharmacopeias, supporting manufacturers targeting the US, European, UK, and Japanese regulatory markets.
| Pharmacopoeia | Regulatory Market | NJ Labs Capability |
|---|---|---|
| USP / NF | United States (FDA) | Full portfolio of USP general chapter tests including <51>, <61>, <62>, <71>, <85>, <232>, <233>, <467>, <643>, <781>, and over 50 additional chapters. Full and partial monograph testing for drug substances, excipients, and finished products. |
| EP (Ph. Eur.) | Europe (EMA) | European Pharmacopoeia compendial testing including Ph. Eur. 2.2.7 (optical rotation), Ph. Eur. 2.2.56 (NPS/amino acids), microbiological methods, and general chapter testing for European regulatory submissions. |
| BP | United Kingdom (MHRA) | British Pharmacopoeia compendial testing for pharmaceutical raw materials and finished products targeting the UK market. |
| JP | Japan (PMDA) | Japanese Pharmacopoeia testing including amino acid NPS methods and general chapter testing for products targeting the Japanese pharmaceutical market. |
For a complete list of USP general chapters and compendial tests performed at NJ Labs, see:
NJ Labs USP Compendial Testing: https://njlabs.com/our-services/usp-compendial-testing/
FDA CGMP regulations (21 CFR Parts 210 and 211) establish mandatory quality system requirements for pharmaceutical testing laboratories, including method suitability, instrument qualification, analyst training, documentation, and data integrity. NJ Labs performs pharmaceutical testing under a CGMP-compliant quality system that includes:
Selecting the right pharmaceutical testing laboratory affects your ability to meet compendial specifications, support regulatory submissions, and maintain product quality throughout the manufacturing lifecycle. The wrong choice contributes to submission delays, OOS investigations, and manufacturing disruptions.
NJ Labs brings over 85 years of analytical testing experience to pharmaceutical quality control. We are an FDA-registered, DEA-registered laboratory operating under cGMP-compliant quality systems, with quality agreements and regulatory package documentation support available for NDA, ANDA, and IND submissions.
Our analytical capabilities span over 50 USP general chapter tests, covering microbiological testing, physical characterization, elemental impurity analysis, residual solvents, amino acids, optical rotation, TOC, and more. We support USP, EP, BP, and JP compendial methods for manufacturers targeting domestic and international regulatory markets.
Every test result from NJ Labs is supported by comprehensive analytical reports that include method parameters, instrument calibration traceability, raw data, and specification comparison formatted for regulatory submission and audit review. Analysts are directly accessible for method questions, OOS investigation support, and regulatory inquiry response.
Every pharmaceutical testing program is different.
Tell us what you’re testing, which specification or compendial standard applies, and what your timeline looks like. Our team can help determine the appropriate testing approach and next steps.
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Pharmaceutical testing services are laboratory services used to evaluate the quality, identity, purity, and other applicable characteristics of pharmaceutical materials and products. Testing is performed on raw materials, APIs, excipients, and finished products using compendial methods and procedures that are appropriately validated or verified under CGMP-compliant quality systems.
