In 2018 nitrosamine impurities (N-nitrosodimethylamine, NDMA) were detected in multiple medicinal products containing Valsartan. NDMA is known to be a probable human carcinogen, and recalls took place.
As an outcome the European Medicines Agency (EMA) published a requirement, that Marketing Authorization Holders (MAH) for human medicines containing chemically synthesized active substances should review their medicines for the possible presence of Nitrosamines. Also other authorities started an equivalent approach, e.g. FDA, Health Canada, TGA (Australia) and Swissmedic, and additional recalls for different drug products took place while detecting NDMA above the allowed limit
For the MAH´s this means a huge additional workload on top of daily business, furthermore additional financial expenses are to be spend. In order to minimize your workload and spending’s, we offer support which could be beneficial especially now during Covid19:
Our technical sales and regulatory team offers support on our complete product portfolio, e.g. but not limited to Hydroxypropyl methylcellulose (HPMC, Hypromellose)
IPEC (International Pharmaceutical Excipients Council) questionnaires for Excipient Nitrosamines Risk Evaluation are prepared and available for:
Metolose SM type (Methylcellulose)
Metolose SH type (Hypromellose 2910, 2906, 2208)
Pharmacoat (Hypromellose 2910)
SB-4 (Hypromellose 2208)
L-HPC (Low-Substituted Hydroxypropyl Cellulose)
HPMCP (Hypromellose Phtalate)
Shin-Etsu AQOAT (Hypromellose Acetate Succinate)
Tylopur 90SH grades (Hypromellose 2910, 2906, 2208)
Tylopur low viscous grades (Hypromellose 2910)
A statement on absence of NDMA is available
You can request this document by getting in touch with us under: Contact
