Nitrosamines and NDSRIs| Cleanchem

Nitrosamines and NDSRIs

itrosamines are chemical impurities classified as probable human carcinogens, formed during drug manufacturing or storage, requiring strict regulatory control to ensure patient safety.

Nitrosamines and NDSRIs – Cleanchem Laboratories

Cleanchem Laboratories is committed to supporting the pharmaceutical industry in the detection, control, and management of nitrosamines and NDSRIs (Nitrosamine Drug Substance-Related Impurities). With growing regulatory scrutiny from agencies such as the USFDA, EMA, and CDSCO, effective monitoring of nitrosamines is critical to ensuring drug safety, efficacy, and compliance.

What are Nitrosamines?

Nitrosamines are a class of chemical impurities that may form during the manufacturing, storage, or packaging of pharmaceuticals. They are of concern because:

Many nitrosamines are classified as probable human carcinogens.
Even trace levels above the permissible daily intake (PDI) can pose long-term safety risks.
Regulatory agencies worldwide require strict control and risk assessment of nitrosamine contamination.

Nitrosamines can arise from:

Use of certain raw materials, solvents, or reagents.
Degradation of drug substances under specific conditions.
Contamination from manufacturing processes or packaging components.

What are NDSRIs?

NDSRIs (Nitrosamine Drug Substance-Related Impurities) are a specific sub-class of nitrosamines that are structurally linked to the active pharmaceutical ingredient (API).

They form when a drug substance itself contains vulnerable functional groups capable of nitrosation.
NDSRIs are often API-specific and more complex to detect and quantify.
Regulatory guidelines now require pharmaceutical companies to conduct NDSRI risk assessments for all APIs and finished dosage forms.

Why Nitrosamine & NDSRI Testing Matters

Patient Safety – Detecting and controlling carcinogenic impurities.
Regulatory Compliance – Meeting USFDA, EMA, WHO, and CDSCO requirements.
Quality Assurance – Ensuring medicines are safe, effective, and free from unacceptable impurity levels.
Market Access – Preventing product recalls, bans, or import restrictions.

Cleanchem Laboratories’ Expertise

At Cleanchem Laboratories, we provide:

Validated Analytical Methods – Using advanced LC-MS/MS, GC-MS, and NMR techniques for nitrosamine detection.
Reference Materials – High-quality impurity reference standards for nitrosamines and NDSRIs.
Risk Assessment Support – Assisting manufacturers with nitrosamine risk evaluation and control strategies.
Regulatory Guidance – Helping pharma partners comply with evolving nitrosamine guidelines.

Types of Nitrosamine-Related Standards Offered

Common nitrosamines (NDMA, NDEA, NMBA, NDBA, DIPNA, EIPNA, etc.).
API-specific NDSRI standards tailored to regulatory submissions.
Custom synthesis of rare or novel nitrosamine impurities.

Conclusion

Nitrosamines and NDSRIs represent one of the most pressing challenges in global pharmaceutical quality assurance. Cleanchem Laboratories supports manufacturers with reference standards, analytical solutions, and regulatory expertise to ensure that every product meets international safety benchmarks.

By partnering with us, you ensure patient safety, regulatory compliance, and product reliability across markets.