Source 4-Methyl Imidazole
-
Post Date:
Dec 30,2025
-
Expiry Date:
Dec 30,2025
-
Detailed Description:
Dear Sir,
We would like you to Source 4-Methyl Imidazole CAS No 822-36-6 for the SRA market.
This material is used as a KSM for manufacturing one of our Oncology API Nilotinib. This API we will be filing it in the SRA market.
For this selection of Manufacturer is important, as the manufacturer need to support us with documentation and also facilitate Vendor Audit Virtual mode to start with and Physical mode once the commercial supplies start.
The Vendor needs to Supply us samples 100gm X 3 batch on FOC basis for evaluation as per our specification attached. The samples can be shipped through DHL/FEDEX. We will pay the courier charges in India. We don't have account with DHL/FEDEX.
Below is the List of documentation which we will require Kindly mark Yes /Now and revert.
List of documents for Qualification of KSM/ INT/ KRM/ Excipient (YES /No)
1. Vendor Questionnaire
2. Audit Date Virtual Mode/ Physical Mode
3. Quality Agreement
4. Process Flow Chart/ Brief Manufacturing Process
5. Route of Synthesis (ROS)
6. Declaration of Changes
7. Safety Material Data sheet (MSDS)
8. Specification and Method of analysis (MOA)
9. COA of three different batches.
10. Certificates regarding Quality system, (GMP, ISO, etc...)
11. Residual Solvent declaration
12. Impurity profile
13. BSE/TSE Declaration
14. Stability Data / Hold Time study
15. Genetically Modified Organisms certificate (GMO)
16. Nitrosamine impurity declaration/ Nitrosamine risk assessment (if applicable)
17. Elemental Impurity Declaration
18. Manufacturing/packaging/labelling details
19. Reworking/Reprocess Statement
20. Statement for use of recovered solvent
21. Declaration for Genotoxic Impurity
22. Gluten free declaration
23. Aflatoxin free declaration (if Plant Origin - agricultural crops)
24. Dioxane free declaration (for Chemical Origin material)
25. Melamine free declaration
26. Allergen free declaration
27. Halal-Kosher Certification (if Animal Origin material)
Please note once sample is approved, and all documentary support and Virtual Audit agreed . We will be able to place order for the PV batch Qty and Commercial order.
Request you to share the COA material as per our specification.
Our Annual requirement would be around 100 kg. Request you to quote price for 10kg, 25 Kg, 50 Kg and 100Kg on CIF Air & Sea Mumbai.
Let us have your confirmation for the same
Your prompt response will be highly appreciated.