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.
4-dihydropyridine-3; 5-dicarboxylate
CAS:88150-42-9
Chemical Formula:C20H25ClN2O5
MW:408.88
Availability: R&D; Commercialization
⬤ CAS No.88150-42-9
⬤ Packaging type:
20kg barrel;5kg barrel;1kg bag;500g bag ; Customized Packaging
| Product Name | 3-Ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate |
| CAS | 88150-42-9 |
| Chemical Formula | C20H25ClN2O5 |
| Molecular Weight | 408.88 |
| EINECS Number | 1308068-626-2 |
| Related Categories | Cardiovascular APIs; Cardiovascular drugs |
| Manufacturer | Shandong Tianming Pharmaceutical Group |
| Indication | Chronic Heart Failure (NYHA II-IV) |
| Mechanism of Action | ARN Dual Inhibitor (Angiotensin Receptor-Neprilysin Inhibitor) |
| Melting Point | 178-179°C |
| Boiling Point | 527.2±50.0 °C (Predicted) |
| Density | 1.227±0.06 g/cm³ (Predicted) |
| RTECS Number | US7968329 |
| Storage Conditions | Keep in dark place, Inert atmosphere, Store in freezer, under -20°C |
| Solubility | Soluble in DMSO (up to 25 mg/ml), DMF (up to 25 mg/ml), or Ethanol (up to 25 mg/ml) |
| Acid Dissociation Constant (pKa) | pKa 8.6 (Uncertain) |
| Appearance | White to off-white crystalline powder |
| Color | White |
| Water Solubility | 75.3 mg/L |
| BCS Class | 1 |
| Stability | Stable in DMSO, DMF, or Ethanol solutions at -20°C for up to 3 months |
| Contraindications | Hypersensitivity to any component, history of angioedema with ACEi or ARB |
| Drug Interactions | Monitor for potential interactions with ACEi, ARB, or aliskiren in diabetics |
| Special Populations | Dose adjustments for renal and hepatic impairment, elderly patients |
| Adverse Reactions | Includes hypotension, hyperkalemia, and angioedema |
| Action | it is a new generation of long-acting, alkaline dihydropyridine calcium channel antagonists and is a representative of the third generation of calcium antagonists. |
| Mechanism of Action | it can reduce calcium influx, and its inhibitory effect on calcium-induced aortic contraction is twice that of nifedipine. |
| Application | it is a long-acting calcium channel blocker that can be used to treat cardiovascular diseases such as angina pectoris, hypertension, and congestive heart failure. |
| Use | Long-acting dihydropyridine calcium antagonist. It can be used alone or in combination with other antihypertensive drugs for hypertension and can also be used for patients with stable angina pectoris. |
Exceptional Product Quality
“We have been sourcing pharmaceuticals from Tianming Pharmaceutical for several years now, and their product quality has consistently exceeded our expectations. Each batch undergoes rigorous testing, ensuring we receive only the highest quality products. This reliability has significantly contributed to our trust and satisfaction with their services. Highly recommended!”
June 15, 2023
Outstanding Technical Guidance
“The technical guidance provided by Tianming Pharmaceutical’s team has been invaluable to our research and development projects. Their experts are knowledgeable, responsive, and always willing to assist with detailed explanations and support. Their guidance has enabled us to optimize our processes and achieve remarkable results. We couldn’t ask for a better partner.”
June 15, 2023
Superior Service Experience
“Our experience with Tianming Pharmaceutical has been nothing short of excellent. Their customer service team is exceptionally responsive and dedicated to meeting our needs. From initial consultation to after-sales support, they have provided seamless, professional service. Their commitment to customer satisfaction is truly commendable.”
June 15, 2023
Precise Product Specifications
“Tianming Pharmaceutical has impressed us with their adherence to precise product specifications. Each order is meticulously packaged and delivered exactly as requested, ensuring that we receive products that perfectly meet our requirements. Their attention to detail and commitment to accuracy have made them a trusted supplier for our business.”
June 15, 2023
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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