Control nitrosamines with low nitrite excipients from BASF
More than 80 years ago, BASF invented PVPs, and we fully understand their chemistry. We have excipients with low nitrites, particularly povidones (PVPs), copovidones and crospovidones. Our povidones, copovidones and crospovidones have always been low nitrite grades with high lot-to-lot consistency.
You can continue using BASF excipients as-is
- No efforts or costs in qualifying a new “low nitrite” or “controlled nitrite” grade.
- Assured supply chain resiliency since you can order povidone with low nitrites from any of our 3 global sites:
USA, Germany and China. - No need for costly reformulations.
We have measured, and not detected nitrites in our products.
Our LOQ and LODs are:
Povidones Kollidon® 30, 12 PF & 17 PF
LOQ = 0.1 ppm; Ion Chromatography
High molecular weight povidone Kollidon® 90 Evo, copovidones (Kollidon® VA 64 & VA 64 Fine) and crospovidone Kollidon® CL grades
LOQ = 2 ppm and LOD < 0.7 ppm; Ion Chromatography
About Nitrosamines
In pharma, nitrosamines are formed from the reaction of secondary or tertiary amines (usually from the API) with nitrites (from excipients or process impurities). There are two categories of nitrosamine impurities:
- Nitrosamine Drug Substance-Related Impurities (NDSRIs) = formed from the API and its process impurities. Regulatory agencies have established acceptable intake (AI) limits for these. [1,2]
- Nitrosamines from the formulation and drug product manufacturing process (impacted by water quality, high heat and humid processes, etc).
- Up to 40% of common APIs and 30% of API impurities can form NDSRIs. [3]
- Nitrites in excipients can lead to both types of nitrosamine impurities.
- As of 2023, the average nitrite content in excipients is 0.83 ppm. [4]
Published articles have consistently demonstrated that BASF excipients have the lowest nitrite values and are seen as best-in-class by our customers.
For crospovidones
NDMA formation due to active ingredient degradation and nitrite traces in drug product
For povidones
Avoiding N-nitrosodimethylamine formation in metformin pharmaceuticals by limiting dimethylamine and nitrite
Table 1. Nitrites in crospovidone from different suppliers
Understanding nitrite analytical results
Limit of Detection (LOD)
The lowest amount of nitrite we can see and reliably measure
Limit of Detection (LOD)
The lowest amount of nitrite we can see
See the full technical brochure on “Control nitrosamines with low nitrite excipients” here
(click the picture to download the brochure)
Source: BASF technical brochure “Control nitrosamines with low nitrite excipients”
Do you need more information or a sample of BASF excipients?