CARCINOGENS UNDER THE SCAN
Express Pharma|February 01-15, 2020
As trace amounts of cancer-causing contaminants continue to crop up in certain medicines, pharma companies are upgrading their testing methods and equipment to meet increased regulatory scrutiny. The result? Safer medicines but even thinner margins
Viveka Roychowdhury
CARCINOGENS UNDER THE SCAN

It is now one and a half years since the carcinogenic contaminant N-nitrosodimethylamine (NDMA) was first detected in sartans in June 2018. The fact that high blood pressure medicines are prescribed for long time use, on a daily basis added to the risk that life long use of NDMA, even in trace amounts, was definitely more harmful than the occasional exposure to the carcinogen from certain food and environmental sources.

While global regulators alerted companies and distributors, pharma companies withdrew their stocks from circulation. Once tests confirmed the presence, batches were recalled. The presence was found to be an impurity in API supplied by a Chinese API manufacturer, Zhejiang Huahai and linked to a change in the process of synthesis.

It was almost action replay in September 2019, when trace amounts of NDMA were found in rantidine, an anti-ulcerant, commonly prescribed and available as OTC brands as well. Unlike sartans, ranitidine is not prescribed for long term use. And unlike sartans, the contaminant is not part of the medicine but thought to have been formed during the testing process, when the high temperature required for gas chromatography-mass spectrometry (GC-MS) caused ranitidine to react with itself and form nitrosamines.

Though the US online pharmacy Valisure which detected this felt that there was evidence to suggest NDMA formation under these conditions in the human body, the US FDA did not believe this was the case. The agency said that GC-MS was the suggested testing procedure for nitrosamine impurities in sartans, not in ranitidine. For the latter, the US FDA prescribed an alternative liquid chromatography-high resolution mass spectrometry (LC-HRMS) method, which showed much lower levels of nitrosamine impurities than Valisure. NDMA and N-nitrosodiethylamine (NDEA) have also been found in pioglitazone, used to treat type 2 diabetes mellitus.

The aftermath

هذه القصة مأخوذة من طبعة February 01-15, 2020 من Express Pharma.

ابدأ النسخة التجريبية المجانية من Magzter GOLD لمدة 7 أيام للوصول إلى آلاف القصص المتميزة المنسقة وأكثر من 9,000 مجلة وصحيفة.

هذه القصة مأخوذة من طبعة February 01-15, 2020 من Express Pharma.

ابدأ النسخة التجريبية المجانية من Magzter GOLD لمدة 7 أيام للوصول إلى آلاف القصص المتميزة المنسقة وأكثر من 9,000 مجلة وصحيفة.

المزيد من القصص من EXPRESS PHARMA مشاهدة الكل
Powerful Process Control with IND500x Weighing Indicators
Express Pharma

Powerful Process Control with IND500x Weighing Indicators

Ensuring consistent quality in hazardous environments, particularly in Ex-Areas (Zone 1/21, Division 1), is a critical aspect of industrial operations. The IND500x weighing indicators from METTLER TOLEDO provide a robust solution for these challenging settings, offering optimized safety and productivity.

time-read
1 min  |
November 2024
Ensuring clean room integrity with prime clean reset high-speed doors
Express Pharma

Ensuring clean room integrity with prime clean reset high-speed doors

Prime Clean Reset high-speed doors ensure airtight seals, minimising air permeability and contamination in clean rooms. Designed for sensitive environments, they enhance operational efficiency and meet rigorous regulatory standards, making them ideal for pharmaceutical and biotech industries

time-read
3 mins  |
November 2024
Complete environmental monitoring solution - testo Saveris Pharma
Express Pharma

Complete environmental monitoring solution - testo Saveris Pharma

There are several critical applications in the industry like research and development that demand for continuous & reliable monitoring of important environmental parameters.

time-read
3 mins  |
November 2024
Adaptive Manufacturing:-The new flexibility in medical device assembly
Express Pharma

Adaptive Manufacturing:-The new flexibility in medical device assembly

Unlike traditional, rigid production lines, B&R's adaptive machines seamlessly adjust to the requirements of each device, dynamically adapting to each unique process

time-read
3 mins  |
November 2024
Reshaping pharma safety with active packaging innovations
Express Pharma

Reshaping pharma safety with active packaging innovations

CILICANT is revolutionising active packaging with solutions tailored for the most sensitive formulations. Meet the innovators driving stability, safety, and impurity control in pharma packaging at CPhI India

time-read
1 min  |
November 2024
UNLOCKING GROWTH FRONTIERS
Express Pharma

UNLOCKING GROWTH FRONTIERS

Vadodara Pharma Summit 2024 brought together industry leaders and experts to highlight the city's pivotal role in India's pharma landscape and explore collaborative strategies to strengthen India's pharma innovation ecosystem

time-read
9 mins  |
November 2024
Optimising cloud provisioning for pharmaceutical compliance and operational excellence
Express Pharma

Optimising cloud provisioning for pharmaceutical compliance and operational excellence

Suresh Perikala, Senior Engineering Lead - DevOps and Cloud Engineering Practice, Altimetrik

time-read
3 mins  |
November 2024
Accelerating pharma's sustainability efforts
Express Pharma

Accelerating pharma's sustainability efforts

Avinaw Prasad, Director, Climate Change & Sustainability, Deloitte India explains why integrating sustainability into the core pharma business strategy is essential for long-term success, analyses key focus areas and policy pushes which can incentivise companies to further evolve on the sustainability path

time-read
5 mins  |
November 2024
Drug Repurposing: Unlocking access to rare solutions
Express Pharma

Drug Repurposing: Unlocking access to rare solutions

Drug repurposing, a quick, cost-effective path to deliver existing treatments to patients, can serve to expedite and expand healthcare access for patients with rare diseases

time-read
8 mins  |
November 2024
Optimising spend, maximising growth
Express Pharma

Optimising spend, maximising growth

Express Pharma, in partnership with IPA and CHEMEXCIL, powered by SAP, recently organised a thought leadership conclave on 'Reimagining spend management and supply chain' where cross functional experts explored strategies to drive value through supply chain transformation

time-read
7 mins  |
November 2024