Indian Pharmacopoeia Commission Launches
Seven Nitrosamine Impurity Reference Standards
The Indian Pharmacopoeia Commission (IPC) has taken an
important step towards strengthening drug quality and safety in India by
launching seven Indian Pharmacopoeia Nitrosamine Impurities Reference
Standards. The standards were launched on 25 August 2026 during the IPC’s first
interactive meeting held at the Central Drugs Laboratory and Central Cosmetics
Laboratory in Kolkata, West Bengal.
Indian Pharmacopoeia Commission
¨
The Indian Pharmacopoeia
Commission (IPC) is an autonomous organisation functioning under the Ministry
of Health and Family Welfare. It plays an important role in establishing
standards for the quality, purity and identity of medicines in India.
¨
The Commission develops
pharmacopoeial standards and provides reference materials and standards
required by laboratories for drug quality testing and quality control. Its work
contributes to strengthening India’s pharmaceutical quality assurance system.
What are Nitrosamine Impurities?
¨
Nitrosamines are a class
of chemical compounds, several of which are associated with genotoxic and
carcinogenic properties. These impurities may be unintentionally formed during
the manufacturing process of pharmaceutical products.
¨
They may also arise due
to packaging, storage conditions or contamination. Therefore, accurate
detection and measurement of nitrosamine impurities in medicines is important
for ensuring pharmaceutical safety.
Seven Reference Standards Launched
The seven nitrosamine impurity reference
standards launched by the IPC are
1. N-Nitrosodimethylamine
(NDMA)
2.
N-Nitrosodiethylamine
(NDEA)
3.
N-Nitrosoethylisopropylamine
(NEIPA)
4.
N-Nitrosodibutylamine
(NDBA)
5.
N-Nitrosomethylphenylamine
(NMPA)
6.
N-Nitrosodiisopropylamine
(NDIPA)
7. N-Nitroso-N-methyl-4-aminobutyric
acid (NMBA)
Importance of Reference Standards
¨
Reference standards are
certified substances used by laboratories to identify, compare and quantify
specific substances present in drug samples. The availability of these seven
nitrosamine reference standards will help laboratories conduct more accurate
and reliable testing of pharmaceutical products.
¨
The initiative is
expected to strengthen drug quality control, laboratory testing capabilities and
pharmaceutical safety in India. It will also support better monitoring of
potentially harmful nitrosamine impurities and contribute to ensuring the
safety and quality of medicines available to patients.
