| Size | Price | Stock | Qty |
|---|---|---|---|
| 1mg |
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| 5mg |
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| 10mg |
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| Other Sizes |
| Targets |
Target: Histamine H1 Receptor (as an impurity reference standard for Cetirizine, which is a specific, orally active, long-acting antagonist of the histamine H1-receptor). The impurity itself is not intended for pharmacological use but is an analytical standard.
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|---|---|
| ln Vitro |
In vitro, Cetirizine Impurity C diHCl has no direct biological activity and is not intended for efficacy studies. The parent compound Cetirizine is a potent H1 antihistamine. As an impurity, it is used as a reference standard for pharmaceutical quality control, not for biological evaluation.
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| ln Vivo |
No in vivo studies are performed with Cetirizine Impurity C diHCl. The compound is a pharmaceutical impurity standard and is not administered to animals for efficacy studies. The parent drug Cetirizine is used clinically for allergic rhinitis and urticaria.
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| Enzyme Assay |
For cell-free impurity analysis by HPLC: Cetirizine Impurity C diHCl reference standard is dissolved in mobile phase (e.g., phosphate buffer pH 3.0: acetonitrile) at a concentration of 0.1-1 mg/mL. The solution is injected into an HPLC system equipped with a C18 column (250×4.6 mm, 5 um). UV detection is performed at 230 nm. The retention time is compared to the Cetirizine peak for impurity identification and quantitation. A standard curve is prepared using the reference standard.
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| Cell Assay |
No cell-based assays are performed with this impurity standard. The compound is exclusively a chemical reference standard used in pharmaceutical quality control laboratories for testing and validation. It is not intended for biological evaluation in cells or tissues.
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| Animal Protocol |
Cetirizine Impurity C diHCl is not administered to animals. It is used as a reference standard for the analysis of Cetirizine drug substance and drug products in stability studies, release testing, and method validation. No in vivo animal studies are conducted with this impurity standard.
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| ADME/Pharmacokinetics |
PK properties are not applicable for Cetirizine Impurity C diHCl as it is an analytical standard, not a drug substance. The parent compound Cetirizine has oral bioavailability >90%, Tmax 1-2 h, elimination half-life 8-10 h, and is primarily excreted unchanged in urine. The labeled impurity standard is not used for PK studies.
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| Toxicity/Toxicokinetics |
No toxicity data are reported for Cetirizine Impurity C diHCl. It is an impurity standard for pharmaceutical quality control and is not intended for human consumption. The parent drug Cetirizine has a favorable safety profile with mild adverse effects including somnolence, dry mouth, and headache. The impurity standard is for research use only.
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| References |
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| Additional Infomation |
Cetirizine Impurity C diHCl is a pharmaceutical reference standard, not an active drug substance. It is not FDA-approved for therapeutic use. It is used for analytical method development, method validation, quality control (QC), and abbreviated new drug application (ANDA) submissions for Cetirizine-containing pharmaceutical products. It is essential for compliance with EP, USP, and JP impurity testing requirements.
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| Molecular Formula |
C21H27CL3N2O3
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|---|---|
| Molecular Weight |
461.81
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| Exact Mass |
460.108
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| CAS # |
2702511-37-1
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| PubChem CID |
129318506
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| Appearance |
White to off-white solid powder
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| Hydrogen Bond Donor Count |
3
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| Hydrogen Bond Acceptor Count |
5
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| Rotatable Bond Count |
8
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| Heavy Atom Count |
29
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| Complexity |
451
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| Defined Atom Stereocenter Count |
0
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| SMILES |
C(C1C=CC=CC=1)(C1C=CC=CC=1Cl)N1CCN(CCOCC(=O)O)CC1.Cl.Cl
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| InChi Key |
MUZLUPGCGALIKR-UHFFFAOYSA-N
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| InChi Code |
InChI=1S/C21H25ClN2O3.2ClH/c22-19-9-5-4-8-18(19)21(17-6-2-1-3-7-17)24-12-10-23(11-13-24)14-15-27-16-20(25)26;;/h1-9,21H,10-16H2,(H,25,26);2*1H
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| Chemical Name |
2-[2-[4-[(2-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic acid;dihydrochloride
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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 Note: Please store this product in a sealed and protected environment, 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)
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| Solubility (In Vitro) |
DMSO : ~100 mg/mL (~216.54 mM)
H2O : ~83.33 mg/mL (~180.44 mM) |
|---|---|
| Solubility (In Vivo) |
Solubility in Formulation 1: ≥ 2.5 mg/mL (5.41 mM) (saturation unknown) in 10% DMSO + 40% PEG300 + 5% Tween80 + 45% Saline (add these co-solvents sequentially from left to right, and one by one), clear solution.
For example, if 1 mL of working solution is to be prepared, you can add 100 μL of 25.0 mg/mL clear DMSO stock solution to 400 μL PEG300 and mix evenly; then add 50 μL Tween-80 to the above solution and mix evenly; then add 450 μL normal saline to adjust the volume to 1 mL. Preparation of saline: Dissolve 0.9 g of sodium chloride in 100 mL ddH₂ O to obtain a clear solution. Solubility in Formulation 2: ≥ 2.5 mg/mL (5.41 mM) (saturation unknown) in 10% DMSO + 90% (20% SBE-β-CD in Saline) (add these co-solvents sequentially from left to right, and one by one), clear solution. For example, if 1 mL of working solution is to be prepared, you can add 100 μL of 25.0 mg/mL clear DMSO stock solution to 900 μL of 20% SBE-β-CD physiological saline solution and mix evenly. Preparation of 20% SBE-β-CD in Saline (4°C，1 week): Dissolve 2 g SBE-β-CD in 10 mL saline to obtain a clear solution. View More
Solubility in Formulation 3: ≥ 2.5 mg/mL (5.41 mM) (saturation unknown) in 10% DMSO + 90% Corn Oil (add these co-solvents sequentially from left to right, and one by one), clear solution. Solubility in Formulation 4: 25 mg/mL (54.13 mM) in PBS (add these co-solvents sequentially from left to right, and one by one), clear solution; with ultrasonication. |
| Preparing Stock Solutions | 1 mg | 5 mg | 10 mg | |
| 1 mM | 2.1654 mL | 10.8270 mL | 21.6539 mL | |
| 5 mM | 0.4331 mL | 2.1654 mL | 4.3308 mL | |
| 10 mM | 0.2165 mL | 1.0827 mL | 2.1654 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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