| Size | Price | Stock | Qty |
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| 10mg |
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| 25mg |
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| 50mg |
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| 100mg |
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| Other Sizes |
| Targets |
As an impurity, Amlodipine besilate impurity D does not have a specific biological target. However, amlodipine itself targets voltage-gated calcium channels, specifically L-type calcium channels. Impurities are monitored in pharmaceutical products to ensure that they do not exceed acceptable limits, as they may affect the safety, efficacy, or stability of the drug product. The impurity is typically present at very low levels and is not expected to contribute to the therapeutic effect.
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|---|---|
| ln Vitro |
Amlodipine besilate impurity D is used as a reference standard and is not evaluated for biological activity. However, amlodipine itself has well-characterized in vitro activity as a calcium channel blocker. Impurities are assessed for their potential impact on the quality and safety of the drug product. The impurity profile of amlodipine besilate is monitored using chromatographic methods to ensure compliance with regulatory specifications.
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| ln Vivo |
Amlodipine besilate impurity D is not a drug and is not evaluated in in vivo efficacy studies. The impurity is monitored in amlodipine formulations to ensure product quality and safety. Regulatory agencies such as the USP, EP, and JP specify limits for impurities in amlodipine besilate drug substances and products. The impurity is used in stability studies to assess the degradation of amlodipine under various conditions.
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| Enzyme Assay |
In analytical method development, Amlodipine besilate impurity D is dissolved in an appropriate solvent and used as a reference standard. The impurity is typically detected and quantified using high-performance liquid chromatography (HPLC) with UV detection. The method is validated for specificity, linearity, accuracy, precision, and robustness. The impurity's retention time and relative retention time are determined relative to the main component.
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| Cell Assay |
Cell-based assays are not typically performed with Amlodipine besilate impurity D, as it is used as a reference standard for quality control purposes. The impurity is not evaluated for biological activity in cell culture. The focus of studies with this compound is on analytical method development and validation for the detection and quantification of impurities in pharmaceutical products.
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| Animal Protocol |
Animal studies are not performed with Amlodipine besilate impurity D, as it is not a drug. The impurity is monitored in pharmaceutical products to ensure safety and quality. Regulatory guidelines specify limits for impurities based on toxicological data and safety assessments. The impurity is used in stability studies to evaluate the degradation of amlodipine under various conditions, such as temperature, humidity, and light.
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| ADME/Pharmacokinetics |
Amlodipine besilate impurity D is not a drug and does not have a pharmacokinetic profile. As an impurity, it is present at very low levels in drug products. The pharmacokinetics of amlodipine itself are well characterized. Amlodipine has a bioavailability of approximately 60-65%, is highly protein-bound, and has a long half-life of 30-50 hours. It is metabolized in the liver and excreted primarily in the urine.
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| Toxicity/Toxicokinetics |
Amlodipine besilate impurity D is not a drug and is not evaluated for toxicity in the same way as a therapeutic agent. The impurity is monitored in pharmaceutical products to ensure that it does not exceed acceptable limits. Regulatory agencies specify limits for impurities based on toxicological data and safety assessments. The impurity is present at very low levels and is not expected to contribute to the toxicity of the drug product.
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| Additional Infomation |
Amlodipine besilate impurity D is a reference standard used in pharmaceutical quality control for the analysis of amlodipine besilate drug substances and products. It is used in analytical method development, validation, and stability testing. The impurity is identified and quantified using chromatographic methods such as HPLC. The compound is not a drug and is not used for therapeutic purposes. It is available from various chemical suppliers for research and quality control purposes.
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| Molecular Formula |
C20H23N2O5CL
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|---|---|
| Molecular Weight |
406.86002
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| Exact Mass |
406.129
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| CAS # |
113994-41-5
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| PubChem CID |
14271877
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| Appearance |
Typically exists as solid at room temperature
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| Density |
1.2±0.1 g/cm3
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| Boiling Point |
517.9±50.0 °C at 760 mmHg
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| Melting Point |
106-108ºC
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| Flash Point |
267.0±30.1 °C
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| Vapour Pressure |
0.0±1.3 mmHg at 25°C
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| Index of Refraction |
1.562
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| LogP |
3.25
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| Hydrogen Bond Donor Count |
1
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| Hydrogen Bond Acceptor Count |
7
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| Rotatable Bond Count |
10
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| Heavy Atom Count |
28
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| Complexity |
521
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| Defined Atom Stereocenter Count |
0
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| SMILES |
NCCOCC1C(C(OCC)=O)=C(C2C=CC=CC=2Cl)C(C(OC)=O)=C(C)N=1
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| InChi Key |
APZSGEHAFPIYQZ-UHFFFAOYSA-N
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| InChi Code |
InChI=1S/C20H23ClN2O5/c1-4-28-20(25)18-15(11-27-10-9-22)23-12(2)16(19(24)26-3)17(18)13-7-5-6-8-14(13)21/h5-8H,4,9-11,22H2,1-3H3
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| Chemical Name |
3-O-ethyl 5-O-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methylpyridine-3,5-dicarboxylate
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| HS Tariff Code |
2934.99.9001
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| Storage |
Powder -20°C 3 years 4°C 2 years In solvent -80°C 6 months -20°C 1 month |
| Shipping Condition |
Room temperature (This product is stable at ambient temperature for a few days during ordinary shipping and time spent in Customs)
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| Solubility (In Vitro) |
May dissolve in DMSO (in most cases), if not, try other solvents such as H2O, Ethanol, or DMF with a minute amount of products to avoid loss of samples
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|---|---|
| Solubility (In Vivo) |
Note: Listed below are some common formulations that may be used to formulate products with low water solubility (e.g. < 1 mg/mL), you may test these formulations using a minute amount of products to avoid loss of samples.
Injection Formulations
Injection Formulation 1: DMSO : Tween 80： Saline = 10 : 5 : 85 (i.e. 100 μL DMSO stock solution → 50 μL Tween 80 → 850 μL Saline)(e.g. IP/IV/IM/SC) *Preparation of saline: Dissolve 0.9 g of sodium chloride in 100 mL ddH ₂ O to obtain a clear solution. Injection Formulation 2: DMSO : PEG300 ：Tween 80 : Saline = 10 : 40 : 5 : 45 (i.e. 100 μL DMSO → 400 μLPEG300 → 50 μL Tween 80 → 450 μL Saline) Injection Formulation 3: DMSO : Corn oil = 10 : 90 (i.e. 100 μL DMSO → 900 μL Corn oil) Example: Take the Injection Formulation 3 (DMSO : Corn oil = 10 : 90) as an example, if 1 mL of 2.5 mg/mL working solution is to be prepared, you can take 100 μL 25 mg/mL DMSO stock solution and add to 900 μL corn oil, mix well to obtain a clear or suspension solution (2.5 mg/mL, ready for use in animals). View More
Injection Formulation 4: DMSO : 20% SBE-β-CD in saline = 10 : 90 [i.e. 100 μL DMSO → 900 μL (20% SBE-β-CD in saline)] Oral Formulations
Oral Formulation 1: Suspend in 0.5% CMC Na (carboxymethylcellulose sodium) Oral Formulation 2: Suspend in 0.5% Carboxymethyl cellulose Example: Take the Oral Formulation 1 (Suspend in 0.5% CMC Na) as an example, if 100 mL of 2.5 mg/mL working solution is to be prepared, you can first prepare 0.5% CMC Na solution by measuring 0.5 g CMC Na and dissolve it in 100 mL ddH2O to obtain a clear solution; then add 250 mg of the product to 100 mL 0.5% CMC Na solution, to make the suspension solution (2.5 mg/mL, ready for use in animals). View More
Oral Formulation 3: Dissolved in PEG400 (Please use freshly prepared in vivo formulations for optimal results.) |
| Preparing Stock Solutions | 1 mg | 5 mg | 10 mg | |
| 1 mM | 2.4578 mL | 12.2892 mL | 24.5785 mL | |
| 5 mM | 0.4916 mL | 2.4578 mL | 4.9157 mL | |
| 10 mM | 0.2458 mL | 1.2289 mL | 2.4578 mL |
*Note: Please select an appropriate solvent for the preparation of stock solution based on your experiment needs. For most products, DMSO can be used for preparing stock solutions (e.g. 5 mM, 10 mM, or 20 mM concentration); some products with high aqueous solubility may be dissolved in water directly. Solubility information is available at the above Solubility Data section. Once the stock solution is prepared, aliquot it to routine usage volumes and store at -20°C or -80°C. Avoid repeated freeze and thaw cycles.
Calculation results
Working concentration： mg/mL；
Method for preparing DMSO stock solution： mg drug pre-dissolved in μL DMSO (stock solution concentration mg/mL). Please contact us first if the concentration exceeds the DMSO solubility of the batch of drug.
Method for preparing in vivo formulation:：Take μL DMSO stock solution, next add μL PEG300, mix and clarify, next addμL Tween 80, mix and clarify, next add μL ddH2O，mix and clarify.
(1) Please be sure that the solution is clear before the addition of next solvent. Dissolution methods like vortex, ultrasound or warming and heat may be used to aid dissolving.
(2) Be sure to add the solvent(s) in order.
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