Ultimate First Article Approval Checklist For A New Supplier
The first commercial batch from a new intermediate supplier is not a formality. Here is the checklist, the five approval outcomes, and how to log the call.
Linagliptin N-Boc Impurity;Boc-Linagliptin;Linagliptin Impurities;Lingaliptin Intermediates
CAS: 668273-75-4
Chemical Formula:C30H36N8O4
Molecular Weight:572.66
Availability: R&D; Commercialization
⬤ CAS No.668273-75-4
⬤ Our Packaging type:
20kg barrel;5kg barrel;1kg bag;500g bag ; Customized Packaging
| Product Name | Tert-butyl((3s)-1-(7-(but-2-yn-1-yl)-3-Methyl-1-((4-Methylquinazolin-2-yl)Methyl)-2,6-dioxo-2,3,4,5,6,7-hexahydro-1h-purin-8-yl)piperidin-3-yl)carbaMate |
| CAS No. | 668273-75-4 |
| Chemical Formula | C30H36N8O4 |
| Molecular Weight | 572.66 |
| Related Categories | Lingaliptin Intermediates |
| Density | 1.32±0.1 g/cm3(Predicted) |
| Storage conditions | Refrigerator |
| Solubility | DMSO (slightly soluble, heated), methanol (slightly soluble, sonicated) |
| Acidity coefficient (pKa) | 12.13±0.20(Predicted) |
| Form | Solid |
| Color | Off-white to light yellow |
| Note | For synthetic research only: This product is specially designed and used for chemical synthesis research as an intermediate in drug development, organic synthesis and other chemical research fields. Not for human or clinical use |
| Drug development | Synthetic intermediates of Linagliptin;Drug Impurity Research |
| Chemical reagents and organic synthesis | Organic synthesis intermediates;Pharmaceutical intermediates research |
| Quality Control and Analysis | Drug purity testing;Stability studies(Study the impurities that may be produced during the storage or use of drugs and evaluate the stability and safety of drugs) |
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March 18, 2024
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“Few suppliers align so perfectly with EU GMP requirements. Tianming’s commitment to audit-ready quality systems, batch traceability, and purity consistency has streamlined our production processes. Their diligence eliminates regulatory risks—a rare advantage in today’s market.”
February 15, 2024
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June 15, 2024
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April 27, 2024
The first commercial batch from a new intermediate supplier is not a formality. Here is the checklist, the five approval outcomes, and how to log the call.
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