| Size | Price | Stock | Qty |
|---|---|---|---|
| 5mg |
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| 10mg | |||
| Other Sizes |
| Targets |
Impurity C of Alfacalcidol does not have a defined pharmacological target in the context of therapeutic activity. As an impurity of Alfacalcidol, its potential targets would theoretically be related to the vitamin D receptor (VDR) pathway, given that the parent compound Alfacalcidol is a non-selective VDR activator. However, Impurity C is not intended to exert biological activity and is not used as a therapeutic agent. Instead, it serves as a reference standard for quality control and analytical testing in pharmaceutical manufacturing. The compound's presence and concentration are monitored to ensure the purity and safety of Alfacalcidol drug products, as impurities must be controlled within acceptable limits according to regulatory standards.
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|---|---|
| ln Vitro |
In vitro activity data for Impurity C of Alfacalcidol are not applicable, as this compound functions as a pharmaceutical impurity reference standard rather than a biologically active test compound. The compound is not evaluated for biological activity in cell-based or biochemical assays, as its primary use is in analytical method development and quality control for Alfacalcidol pharmaceutical products. In the context of pharmaceutical analysis, the "activity" of Impurity C refers to its chromatographic behavior and detection characteristics in analytical methods such as high-performance liquid chromatography (HPLC) rather than any pharmacological or biological effect. The compound is characterized by its molecular formula, molecular weight, and structural identity for reference purposes.
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| ln Vivo |
In vivo activity data for Impurity C of Alfacalcidol are not applicable, as this compound is a pharmaceutical impurity reference standard and is not intended for therapeutic administration or biological testing in animal models. Impurity C is used exclusively for analytical purposes in quality control and method validation for Alfacalcidol drug products. No in vivo pharmacological studies have been conducted with this impurity, as it is not a candidate for drug development or therapeutic use. Its relevance is limited to ensuring the purity, safety, and regulatory compliance of Alfacalcidol pharmaceutical formulations by serving as a reference standard for impurity identification and quantification.
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| Enzyme Assay |
The in vitro enzyme/receptor binding assay for Impurity C of Alfacalcidol is not applicable, as this compound is not evaluated for biological activity. Instead, the compound is used as a reference standard in analytical chemistry assays for quality control purposes. The typical analytical protocol involves dissolving the impurity reference standard in an appropriate solvent such as DMSO (6.67 mg/mL) and preparing a series of standard solutions at known concentrations. These standards are injected into a high-performance liquid chromatography (HPLC) system equipped with a suitable column and UV detector. The retention time and peak area of Impurity C are determined and compared to those of the Alfacalcidol drug substance to quantify impurity levels in pharmaceutical samples. Method validation parameters including specificity, linearity, accuracy, precision, and limit of detection are established according to regulatory guidelines.
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| Cell Assay |
In vitro cell-based assays are not applicable for Impurity C of Alfacalcidol, as this compound is a pharmaceutical impurity reference standard used exclusively for analytical chemistry and quality control purposes. The compound is not tested on cultured cells for biological activity, as it is not a therapeutic agent or a candidate for drug development. Instead, Impurity C is utilized in analytical method development and validation to ensure the quality and safety of Alfacalcidol pharmaceutical products. Cell-based studies are not relevant to the compound's intended use, which is limited to serving as a reference standard for identifying and quantifying impurities in drug substance and drug product samples according to pharmacopoeial standards.
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| Animal Protocol |
In vivo animal studies are not applicable for Impurity C of Alfacalcidol, as this compound is a pharmaceutical impurity reference standard and is not intended for administration to animals or therapeutic use. The compound's sole purpose is to serve as a reference material for analytical method development, method validation, and quality control in pharmaceutical manufacturing. No animal studies have been conducted with this impurity, and such studies would not be relevant given the compound's intended use. The focus of work involving Impurity C is on chromatographic analysis and impurity profiling rather than pharmacological or toxicological evaluation. The compound is handled exclusively in laboratory settings for analytical chemistry applications.
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| ADME/Pharmacokinetics |
Pharmacokinetic properties are not applicable for Impurity C of Alfacalcidol, as this compound is a pharmaceutical impurity reference standard and is not administered to living organisms. The compound has a molecular formula of C3₅H4₉N3O4 and a molecular weight of 575.78. For analytical use, Impurity C is soluble in DMSO at a concentration of 6.67 mg/mL (11.58 mM) with ultrasonic and warming to 80degC. The compound should be stored at 4degC, protected from light, and stored under nitrogen for long-term stability. For solution storage, -80degC for 6 months or -20degC for 1 month (protected from light, under nitrogen) is recommended.
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| Toxicity/Toxicokinetics |
Toxicity data for Impurity C of Alfacalcidol are not available, as this compound is a pharmaceutical impurity reference standard used exclusively for analytical purposes rather than therapeutic administration. The compound is not intended for human or animal consumption and is handled only in laboratory settings for quality control applications. Standard laboratory safety precautions should be followed when handling this compound, including the use of appropriate personal protective equipment. As with all reference standards and analytical chemicals, exposure should be minimized, and proper waste disposal procedures should be observed in accordance with local regulations. The compound's toxicity profile has not been characterized, as it is not a candidate for drug development or therapeutic use.
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| References |
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| Additional Infomation |
Impurity C of Alfacalcidol (CAS#: 82266-85-1) is a pharmaceutical reference standard with the molecular formula C3₅H4₉N3O4 and a molecular weight of 575.78. Chemically defined as the triazoline adduct of pre-Alfacalcidol, this compound is a named impurity in the European Pharmacopoeia (EP) monograph for Alfacalcidol. Alfacalcidol is a non-selective vitamin D receptor (VDR) activator used in the treatment of osteoporosis and renal osteodystrophy. Impurity C is specifically designated for use in analytical method development, method validation, and quality control required for Abbreviated New Drug Applications (ANDA) and commercial pharmaceutical production. The compound serves as a critical reference standard for ensuring the purity and safety of Alfacalcidol drug products. No clinical trials or therapeutic applications have been reported for this impurity.
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| Molecular Formula |
C35H49N3O4
|
|---|---|
| Molecular Weight |
575.7813
|
| Exact Mass |
575.372
|
| CAS # |
82266-85-1
|
| PubChem CID |
127255638
|
| Appearance |
White to off-white solid powder
|
| LogP |
5.943
|
| Hydrogen Bond Donor Count |
2
|
| Hydrogen Bond Acceptor Count |
4
|
| Rotatable Bond Count |
7
|
| Heavy Atom Count |
42
|
| Complexity |
1130
|
| Defined Atom Stereocenter Count |
8
|
| SMILES |
CC1=C(C[C@@H](C[C@@H]1O)O)[C@@H]2C=C3[C@@H]4CC[C@@H]([C@]4(CC[C@H]3N5N2C(=O)N(C5=O)C6=CC=CC=C6)C)[C@H](C)CCCC(C)C
|
| InChi Key |
PTIHYNIKYFVMFI-NMEOVDRUSA-N
|
| InChi Code |
InChI=1S/C35H49N3O4/c1-21(2)10-9-11-22(3)28-14-15-29-27-20-31(26-18-25(39)19-32(40)23(26)4)38-34(42)36(24-12-7-6-8-13-24)33(41)37(38)30(27)16-17-35(28,29)5/h6-8,12-13,20-22,25,28-32,39-40H,9-11,14-19H2,1-5H3/t22-,25+,28-,29+,30-,31+,32+,35-/m1/s1
|
| Chemical Name |
(1R,7S,10R,13R,14R)-7-[(3S,5S)-3,5-dihydroxy-2-methylcyclohexen-1-yl]-14-methyl-13-[(2R)-6-methylheptan-2-yl]-4-phenyl-2,4,6-triazatetracyclo[7.7.0.02,6.010,14]hexadec-8-ene-3,5-dione
|
| 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 Note: (1). This product requires protection from light (avoid light exposure) during transportation and storage. (2). Please store this product in a sealed and protected environment (e.g. under nitrogen), avoid exposure to moisture. |
| Shipping Condition |
Room temperature (This product is stable at ambient temperature for a few days during ordinary shipping and time spent in Customs)
|
| Solubility (In Vitro) |
DMSO : ~6.67 mg/mL (~11.58 mM)
|
|---|---|
| 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 | 1.7368 mL | 8.6839 mL | 17.3677 mL | |
| 5 mM | 0.3474 mL | 1.7368 mL | 3.4735 mL | |
| 10 mM | 0.1737 mL | 0.8684 mL | 1.7368 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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