Regulatory Differences Between API and Intermediate Manufacturing: A Practical Guide
Regulatory differences between API and intermediate manufacturing under ICH Q7, FDA, EMA, and NMPA. GMP boundaries, DMF filing, starting material justification.
3-(Pyrrolidin-2-yl)pyridine;Nicotine metabolite; 3-Pyridyl-2-pyrrolidine; Nicotine Analog; Nicotinic Receptor Agonist
CAS:494-97-3
Chemical Formula:C9H12N2
MW:148.21
Availability: R&D; Commercialization
⬤ CAS No.494-97-3
⬤ Packaging type:
20kg barrel;5kg barrel;1kg bag;500g bag ; Customized Packaging
| Product Name | Nornicotine |
| CAS Number | 494-97-3 |
| Molecular Formula | C9H12N2 |
| Molecular Weight | 148.21 |
| Synonyms | (±)-Nornicotine, (S)-Nornicotine, 3-(Pyrrolidin-2-yl)pyridine, Nornicotine Base |
| Density | 1.043 g/cm³ |
| Boiling Point | 269.999 ºC at 760 mmHg |
| Flash Point | 111.291 ºC |
| Storage | Store in a cool, dry, well-ventilated area; separate from foodstuffs |
| Purity | ≥96.0% or ≥97.0% |
| Packaging | 10mg, 25mg, 50mg, 100mg |
| Application | Scientific research, drug development, etc. |
| Product Identification | Nornicotine |
| CAS Number: 494-97-3 | |
| Intended Use | For scientific research and development purposes only. Not for human or animal consumption. |
| Safety Precautions | Handle with caution. Wear appropriate personal protective equipment (PPE) including chemical-resistant gloves, safety glasses, and lab coat. |
| Avoid contact with skin, eyes, and mucous membranes. | |
| Work in a well-ventilated area. | |
| In case of contact, immediately flush affected area with water and seek medical attention. | |
| Storage Conditions | Store in a cool, dry, and well-ventilated area. |
| Keep away from heat, sparks, and open flames. | |
| Store separately from food, beverages, and other consumables. | |
| Handling Instructions | Use only in a dedicated laboratory setting under the supervision of a qualified professional. |
| Follow all local regulations and guidelines for handling hazardous chemicals. | |
| Use appropriate tools and equipment for weighing and transferring Nornicotine. | |
| Disposal | Dispose of Nornicotine and any contaminated materials according to local regulations and guidelines for hazardous waste disposal. |
| Do not dispose of in regular trash or down drains. |
| Product Name | Nornicotine |
| Purity | ≥96.0% or ≥97.0% (as per specifications) |
| Appearance | [White Powder] |
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Precise Product Specifications
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Regulatory differences between API and intermediate manufacturing under ICH Q7, FDA, EMA, and NMPA. GMP boundaries, DMF filing, starting material justification.
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