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Nitrogen Analysis and Distillation in Pharmaceutical Laboratories

June 25, 2025

In the high-stakes environment of pharmaceutical laboratories, accuracy and compliance are paramount. Whether ensuring the consistency of raw materials or verifying the nitrogen content in active pharmaceutical ingredients (APIs), laboratories require robust, reliable, and compliant analytical solutions. Among the most critical analytical processes is nitrogen determination, often performed via Kjeldahl analysis and distillation techniques.

Enter VELP Scientifica, a global leader in analytical instrumentation whose solutions are widely trusted across the pharmaceutical sector for their precision, automation, and full regulatory traceability. In Canada, these high-performance instruments are distributed and supported by ATS Scientific Inc., a trusted supplier of premium laboratory technologies.

Why Nitrogen Analysis Matters in Pharma

Nitrogen is a key element in many pharmaceutical compounds. Determining its content is essential for:

  • Validating the composition of amino acids, proteins, and other nitrogen-containing compounds.
  • Ensuring raw material quality, particularly in fermentation processes.
  • Supporting quality control (QC) and batch release by meeting pharmacopoeial standards (e.g., USP, EP).

Inaccurate nitrogen analysis can lead to flawed formulations, regulatory non-compliance, and potential product recalls — consequences no pharmaceutical company can afford.

The Kjeldahl Method: Gold Standard for Nitrogen Analysis

The Kjeldahl method remains the reference technique for determining organic nitrogen. Although modern alternatives like Dumas combustion exist, Kjeldahl analysis remains dominant in the pharmaceutical industry due to:

  • Its broad applicability across sample types.
  • Its alignment with pharmacopeial methods.
  • Its high level of accuracy and reproducibility.

The process involves:

  • Digestion: Sample is digested with sulfuric acid and a catalyst to convert nitrogen to ammonium sulfate.
  • Distillation: The digest is made alkaline and distilled to release ammonia.
  • Titration: Ammonia is captured in boric acid and titrated to quantify nitrogen content.

Modern Alternatives: Dumas Combustion and Elemental Analyzers

While the Kjeldahl method remains widely accepted, many pharmaceutical laboratories are also adopting combustion-based nitrogen analysis for its speed, automation, and chemical-free operation. VELP offers a full suite of high-performance elemental analyzers to meet these evolving needs:

VELP NDA 702 – Dumas Nitrogen Analyzer

An advanced solution for fast, safe nitrogen/protein analysis via combustion. Ideal for high-throughput labs, the NDA 702 delivers results in just 3–4 minutes with no hazardous chemicals required. It is cloud-connected for traceability and remote monitoring.

VELP CN 802 – Carbon/Nitrogen Analyzer

Designed for simultaneous carbon and nitrogen analysis, the CN 802 is perfect for labs analyzing raw materials, fermentation broths, or intermediates. It provides high accuracy, reproducibility, and automated workflows.

VELP EMA 502 – CHNS-O Elemental Analyzer

Offering complete elemental analysis of carbon, hydrogen, nitrogen, sulfur, and oxygen, the EMA 502 supports broader pharmaceutical testing needs with excellent sensitivity and regulatory alignment.

These alternatives provide flexibility for labs seeking rapid turnaround, reduced reagent handling, and compliance with newer sustainability mandates all while maintaining analytical integrity.

Supporting Sustainable Lab Practices

VELP is also a pioneer in green lab initiatives. Their units consume less water and energy, and paired with VELP’s SMS Scrubber systems, they provide effective acid fume neutralization, improving lab safety and environmental compliance.

Investing in Accuracy and Confidence

For pharmaceutical laboratories, investing in VELP Scientifica’s Kjeldahl and distillation systems means more than just upgrading equipment, it’s a commitment to precision, compliance, and operational efficiency. As regulatory demands grow and product complexity increases, having a trusted solution for nitrogen analysis is essential.