Excipient Nitrosamine Risk Assessment Questionnaire
Excipient Information
Excipient Name:
Supplier Details:
Group 1: Nitrosating Agent Usage
1.1: Is sodium nitrite (NaNO2) or any other nitrite or nitrosating agent used as reagents/catalyst?
--Select--
Yes
No
Don't Know
1.1.1: Are secondary/tertiary amines present in the SAME step?
--Select--
Yes
No
Don't Know
1.1.2: Are secondary/tertiary amines present in PREVIOUS/SUBSEQUENT steps?
--Select--
Yes
No
Don't Know
1.2: Is sodium nitrite (NaNO2) or any other nitrite or nitrosating agent used in the preparation of raw materials/intermediates?
--Select--
Yes
No
Don't Know
1.2.1: Are secondary/tertiary amines present in the SAME step?
--Select--
Yes
No
Don't Know
1.2.2: Are secondary/tertiary amines present in PREVIOUS/SUBSEQUENT steps?
--Select--
Yes
No
Don't Know
1.3: Is sodium nitrite (NaNO2) or any other nitrite or nitrosating agent used in the preparation of reagents/catalysts/processing aids?
--Select--
Yes
No
Don't Know
1.3.1: Are secondary/tertiary amines present in the SAME step?
--Select--
Yes
No
Don't Know
1.3.2: Are secondary/tertiary amines present in PREVIOUS/SUBSEQUENT steps?
--Select--
Yes
No
Don't Know
1.4: Is sodium nitrite (NaNO2) or any other nitrite or nitrosating agent generated as impurities during manufacturing?
--Select--
Yes
No
Don't Know
1.4.1: Are secondary/tertiary amines present in the SAME step?
--Select--
Yes
No
Don't Know
1.4.2: Are secondary/tertiary amines present in PREVIOUS/SUBSEQUENT steps?
--Select--
Yes
No
Don't Know
1.5: Is sodium nitrite (NaNO2) or any other nitrite or nitrosating agent deliberately added in process (e.g., cell culture media or fermentation)?
--Select--
Yes
No
Don't Know
1.5.1: Are secondary/tertiary amines present in the SAME step?
--Select--
Yes
No
Don't Know
1.5.2: Are secondary/tertiary amines present in PREVIOUS/SUBSEQUENT steps?
--Select--
Yes
No
Don't Know
Group 2: Availability of Analytical Test Results for Excipient
2.1: Is the Excipient analysed and results available for Nitrites?
--Select--
Yes
No
N/A
2.2: Is the Excipient analysed and results available for Nitrates?
--Select--
Yes
No
N/A
2.3: Is the Excipient analysed and results available for Nitrosamines?
--Select--
Yes
No
N/A
Group 3: Water Usage
3.1: Is water used in the manufacturing process?
--Select--
Yes
No
3.2: How is the water prepared? (Distillation/Ion_exchange/Reverse_osmosis/Potable)
--Select--
Distillation
Ion Exchange
Reverse Osmosis
Potable
3.3: Does the water used involve chloramine treatment?
--Select--
Yes
No
N/A
Group 4: Presence of Secondary/Tertiary Amines
(Answer this only if all Group 1 main responses are “no”.)
4.1: Are secondary/tertiary amines present in the manufacturing process?
--Select--
Yes
No
Don't Know
Group 5: Use of Amide/Primary Amine/Ammonium Salt
5.1: Is any amide, primary amine, or ammonium salt used or present in the manufacturing process?
--Select--
Yes
No
Don't Know
Group 6: Recycled/Recovered Solvents
6.1: Are recycled/recovered nitrogen-containing solvents used in the manufacturing process?
--Select--
Yes
No
Don't Know
Group 7: Equipment & Cleaning Procedures
7.1: Is the excipient produced using multipurpose equipment?
--Select--
Yes
No
Don't Know
7.2: Is the equipment used for manufacturing any material involving nitrites/ nitrosating agents/ with risk of formation of nitrosamines?
--Select--
Yes
No
Don't Know
7.3: Are chloramines used as part of cleaning procedures for manufacturing equipment?
--Select--
Yes
No
Don't Know
Submit