| Size | Price | Stock | Qty |
|---|---|---|---|
| 50mg |
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| 100mg |
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| Other Sizes |
| Targets |
This impurity does not have a defined pharmacological target. As an open-ring derivative of empagliflozin, it may retain some affinity for SGLT-2 but is significantly less active than the parent drug. It is a degradation product or synthetic byproduct formed during the manufacturing of empagliflozin. Its primary relevance is as a reference standard for quality control and analytical testing rather than as a therapeutic agent.
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|---|---|
| ln Vitro |
In vitro activity of this impurity is not characterized as it is not a therapeutic agent. It is used as a reference standard for analytical testing to ensure the quality and purity of empagliflozin drug substance and drug products. It may have weak or negligible SGLT-2 inhibitory activity compared to empagliflozin. Its presence is monitored and controlled in pharmaceutical manufacturing to ensure product safety and efficacy.
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| ln Vivo |
In vivo activity is not applicable as this impurity is not a therapeutic agent. It is not administered to patients and has no therapeutic indication. Its relevance is strictly analytical—it is monitored as a process-related impurity in the manufacturing of empagliflozin to ensure the quality and purity of the final drug product.
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| Enzyme Assay |
In vitro non-cellular assays for this impurity typically involve analytical testing. A common protocol is: (1) prepare a standard solution of the impurity at known concentration; (2) prepare sample solutions of empagliflozin drug substance or drug product; (3) analyze by HPLC or UPLC with UV detection; (4) separate the impurity from the main peak and other impurities; (5) quantify the impurity against a reference standard; and (6) compare the impurity level to the specification limit (typically ≤0.15%). LC-MS/MS may be used for identification and structural confirmation.
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| Cell Assay |
In vitro cellular assays are not applicable as this compound is an analytical impurity standard rather than a biologically active compound. It is not used in cell-based studies. Its utility is limited to quality control testing in pharmaceutical manufacturing. No cell-based assays are performed with this material.
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| Animal Protocol |
In vivo animal experiments are not applicable. This compound is an impurity standard used for analytical testing and is not a drug candidate. No pharmacokinetic or toxicological studies in animals are conducted for this material. It is not administered to living organisms for any purpose.
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| ADME/Pharmacokinetics |
Pharmacokinetic properties are not applicable as this compound is an analytical impurity standard, not a drug. It is not administered to patients or animals. Its chemical properties include a molecular weight of 468.93 and a molecular formula of C₂₃H₂₉ClO₈. It is typically stored refrigerated (2-8°C).
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| Toxicity/Toxicokinetics |
The toxicity profile of this impurity is not separately characterized. As an impurity in a pharmaceutical product, its levels are controlled to ensure patient safety. The specification limit for this impurity in empagliflozin drug substance is typically ≤0.15% (based on ICH guidelines for related substances). It is for research use only and is not intended for human consumption. Standard laboratory safety practices should be followed.
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| Additional Infomation |
This compound is a racemic mixture (hence "racemate" in the name) and is an open-ring impurity of empagliflozin. It is also known as (1R)-1,5-dihydroxyempagliflozin. It is used as a reference standard for quality control testing of empagliflozin drug substance and drug products. This product is not a drug and has no clinical trial or regulatory approval status; it is sold exclusively for research and quality control purposes.
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| Molecular Formula |
C23H29CLO8
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|---|---|
| Molecular Weight |
468.93
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| Exact Mass |
468.16
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| Related CAS # |
1620758-34-0; 2452301-18-5
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| Appearance |
Typically exists as solid at room temperature
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| Density |
1.4±0.1 g/cm3
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| Boiling Point |
770.5±60.0 °C at 760 mmHg
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| Flash Point |
419.8±32.9 °C
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| Vapour Pressure |
0.0±2.8 mmHg at 25°C
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| Index of Refraction |
1.640
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| LogP |
-0.67
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| Chemical Name |
(2S,3R,4R,SR)-1-(4-chloro-3-(4-(((S)-tetrahydrofuran-3-yl)oxy)benzyl)phenyl)hexane-1,2.3.4.5.6-hexaol
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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 | 2.1325 mL | 10.6626 mL | 21.3251 mL | |
| 5 mM | 0.4265 mL | 2.1325 mL | 4.2650 mL | |
| 10 mM | 0.2133 mL | 1.0663 mL | 2.1325 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.
Products are for research use only; We do not sell to patients
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