GADOPENTETATEMEGLUMINE
Gadopentetate dimeglumine
CAS: 86050-77-3
Molecular Formula: C14H20GdN3O10.2C7H17NO5
GADOPENTETATEMEGLUMINE - Names and Identifiers
| Name | Gadopentetate dimeglumine |
| Synonyms | Dimeglumine salt GADOPENTETATEMEGLUMINE Gadopentetate dimeglumine Acide gadopentetique [French] GadopenteticAcidDimeglumineSalt |
| CAS | 86050-77-3 |
| EINECS | 1308068-626-2 |
| InChI | InChI=1/C14H23N3O10.2C7H17NO5.Gd/c18-10(19)5-15(1-3-16(6-11(20)21)7-12(22)23)2-4-17(8-13(24)25)9-14(26)27;2*1-8-2-4(10)6(12)7(13)5(11)3-9;/h1-9H2,(H,18,19)(H,20,21)(H,22,23)(H,24,25)(H,26,27);2*4-13H,2-3H2,1H3;/q;;;+3/p-3/t;2*4-,5+,6+,7+;/m.00./s1 |
GADOPENTETATEMEGLUMINE - Physico-chemical Properties
| Molecular Formula | C14H20GdN3O10.2C7H17NO5 |
| Molar Mass | 938 |
| Storage Condition | Inert atmosphere,Room Temperature |
| Use | This product is for scientific research only and shall not be used for other purposes. |
GADOPENTETATEMEGLUMINE - Risk and Safety
| Toxicity | LD50 i.v. in rats: 10 mmol/kg (Weinmann). |
GADOPENTETATEMEGLUMINE - Gadopentetate Dimeglumine Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of meglumine dimeglumate. BIS-Meglumine (C14H20GdN3O10 • 2C7H17N05) containing cyanoacrylate shall be between 95.0% and 105.0% of the label load.
trait
This product is colorless to light yellow or light yellow green clear liquid.
identification
- This product is diluted with water to prepare a solution containing about 35mg of meglumine phosphonate (equivalent to 14.6mg of meglumine) per 1ml as a test solution, A solution containing about 56mg (corresponding to 14.6mg of meglumine) per 1ml was prepared by dissolving and diluting with water as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions each 2 u1, respectively, on the same silica gel GF 254 thin layer plate, with n-butanol-glacial acetic acid-water (4:1:2) for the display agent, expand, dry, spray with ninhydrin-Cadmium acetate solution (ninhydrin 0.lg, Cadmium acetate 0.25g, glacial acetic acid 1ml, add ethanol to dissolve and dilute to 50ml, shake well), by heating at 120 ° C. For 10 minutes to develop color, the position and color of the main spot displayed by the test solution should be the same as that of the control solution.
- take this product and dilute it with water to make a solution containing about 35mg of meglumine propetic acid dimeglumine per 1 ml (equivalent to 20.4mg propetic acid) as a test solution. The control solution under the item was diluted with water to make a solution containing about 28mg (corresponding to 20.4mg of propranolol) per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions each 2 u1, respectively, on the same silica gel GF 254 thin layer plate, with methanol-acetonitrile-water-glacial acetic acid (5:2:2:0.2) is the developing solvent, spread out, dry, spray with cerium sulfate-arsenious acid solution (take 5g of cerium sulfate, put it in a measuring flask, put it in an ice bath, 50ml of 0.5mol/L sulfuric acid solution cooled to 0°C was added, dissolved by shaking, filtered and refrigerated, as solution A; Another 2.5g of sodium arsenite was taken, 15ml of 1 mol/L sodium hydroxide solution was added to dissolve, refrigerated at 0°C, carefully added 32.5ml of 1 mol/L sulfuric acid solution cooled to 0°C, and added water to 50ml as solution B; before use, mix the same amount of solution A and B, use within 5 minutes), then spray with 1% o-phenylenediamine acetone solution, the position and color of the main spot displayed by the test solution should be the same as that of the reference solution.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- take 5ml of this product, put it in a 25ml measuring flask, dilute it to the scale with water, shake it well, and measure it by UV-Vis spectrophotometry (General rule 0401), there is an absorption maximum at a wavelength of 275nm.
- two items (2) and (3) above can be selected as one item.
examination
- the pH value should be 6.5 to 8.0 (General 0631).
- the color of this product, compared with the yellow 4 or Yellow Green 4 standard colorimetric liquid (General Principles 0901 first method), not deeper.
- meglumine take this product and determine the optical rotation at 25°C (General 0621) according to law. Calculate the content of meglumine according to the following formula, which should be 40.2% ~ 47.1% of the labeled amount of meglumine phosphonate.
- spout acid precise quantity take 5ml of this product into an Erlenmeyer flask, add 25ml of water, add acetic acid-sodium acetate buffer (pH 5.0)[take acetic acid-sodium acetate buffer (pH 4.5), adjust pH value to 5.0]10ml with sodium hydroxide solution, add 0.5ml of Xylenol Orange indicator solution Dropwise, titrate with gadolinium chloride titration solution (0.002mOl/L) until the solution changes from orange-yellow to orange-red, the results of the titration were corrected by a blank test. Each 1 ml of gadolinium chloride titrant (0.002mol/L) corresponds to 0.788mg of c14h23n3014. This product should be 50 ~ 400ug per lml containing Penta acid.
- take an appropriate amount of heavy metal (equivalent to meglumine dimeglumate l. Add 5ml of sodium hydroxide solution, dilute to 40ml with water, shake well, and check according to law (General rule 0821 method 3), containing no more than 20 parts per million of heavy metals.
- bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per lml should be less than 3.0EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using octyl silane bonded silica gel as filler; Tetrabutyl ammonium perchlorate solution (take tetrabutyl ammonium perchlorate 1.7g, add acetonitrile 100ml to dissolve, dilute to 1000ml with water) the detection wavelength was 195nm. The number of theoretical plates shall not be less than 3000 calculated as per the peak of meglumine phosphonate.
- determination precision measure 2ml of the product, put it in a 200ml measuring flask, dilute it to the scale with water, shake it well, take 15ml, put it in a 100ml measuring flask, add 10ml of acetonitrile, dilute to scale with water, shake well, as a test solution, and inject 20ul into the liquid chromatograph to record the chromatogram, dissolve and quantitatively dilute with 10% acetonitrile solution to prepare a solution containing about 1.263 mg per 1 ml, which is determined by the same method and calculated by the external standard method with the peak area. The result is multiplied.
category
diagnostic medication.
specification
(l)10ml:4.69g (2)12ml:5.63g (3)15ml:7.04g(4)20ml based on meglumine diphosphonate (C14H20GdN3O10 • 2C7H17N05): 9.38G
storage
light shielding, closed storage.
Last Update：2022-01-01 11:53:12
GADOPENTETATEMEGLUMINE - Reference Information
| pharmacological effects and applications | meglumine phosphate is white or white crystalline powder, odorless, micro-sweet, easily soluble in water. Gadolinium 16.76%. It is a paramagnetic contrast agent used in magnetic resonance imaging. It is the N-methylglucamine salt of the chelate of gadolinium and diethylarginine pentaacetic acid (DTPA) and is administered intravenously. In vivo, the role of meglumine gallate and other highly hydrophilic, biologically inert compounds the same, intravenous injection, quickly distributed in the extracellular fluid, and in its original form through the glomerular excretion. This product is very hydrophilic substances, and protein binding capacity is minimal. Determination by whole body autoradiography demonstrated more than 90% renal excretion at 1h and 24 h after injection. Very small amounts can be detected in the intestine, not detected in the skin. When severe renal damage, the goods in the body to extend the stay. Residual gadolinium and meglumine pantetate can then be excreted by extracorporeal hemodialysis. This product can enter the diseased tissue through the damaged blood-brain barrier. Clinical Applications: 1. Magnetic resonance imaging of the brain and spine: especially for the display and identification of tumors. Assist in the diagnosis of suspected intracranial (spinal) meningioma, schwannoma, invasive tumors (eg, glioma) and metastases; Show small and/or differential diagnosis of rare tumors, such as hemangioblastoma, ependymoma and pituitary microadenoma; Further determine the spread of non-brain-derived tumors. Magnetic resonance imaging in the spine: differentiating between intraspinal and Extraspinal tumors; Showing the site of tumor parenchyma in known cavity lesions; Determining intraspinal tumor spread. 2. Whole body magnetic resonance imaging: including facial skull, neck, chest, abdomen, female breast, pelvic cavity and limbs and other parts. |
| pharmacokinetics | not absorbed orally. The concentration in blood and tissues reached the peak 1 minute after intravenous injection, and the elimination half-life was about 20 minutes. In the blood vessels rich, extracellular fluid more tissue and the blood brain barrier damaged by the lesion to produce strengthening effect, but can not penetrate the healthy intact blood brain barrier. This product is a larger molecular weight of the chelate, not in the accumulation of cells, mainly in the original form of rapid renal excretion from urine. Intravenous injection after 3 hours of about 80% through the glomerular filtration, renal tubular excretion by the kidney, 24 hours of urine can be discharged more than 90% of the injection volume, renal dysfunction slightly slowed down. About 7% is excreted in the feces. Animal studies have shown that less than about 0.2% of the dose can enter the milk. |
| synthesis | The first step: Synthesis of veratrhalic acid the second step: Synthesis of meglumine veratrhalate |
| dosage | 1. General condition: ① the patient must fast 2 hours before examination. ② the required dose should be injected intravenously, with bolus injection if necessary, followed by immediate start of MRI enhancement scan, preferably within 45 minutes of injection. (3) in the intravascular injection of contrast agent, the patient is best lying flat; At least half an hour after the injection, the patient should be closely observed. (4) when not used immediately, do not draw the drug into the syringe. The remaining contrast agent must be discarded after one examination. It is particularly appropriate to use the pulse series of T1 weighted scan in the enhanced scan. (5) it is suitable for the magnetic field strength of 0.14~1. 5tesla. In this range, it is not affected by the field strength. 2. Dose: intravenous injection. Adults and children over 2 years of age, according to the body weight of 0.2/kg (or 0.1mmol/kg), the maximum dosage of a 0.4/kg. ① magnetic resonance imaging of the head and spine: if necessary, the drug can be administered again within 30 minutes. (2) whole body magnetic resonance imaging: in order to obtain sufficient enhancement, 0.4/kg can be administered at a time. The optimal strengthening time is generally within 45 minutes after injection. To exclude adult lesions or tumor recurrence, the dosage can be increased to 0.6/kg of body weight at a time to increase the credibility of the diagnosis. |
| adverse reaction | 1. Nausea, Vomit and skin or mucous membrane allergic reaction. 2. Patients with allergic tendency are more likely to have allergic reactions than others. In rare cases, hypersensitivity reactions may occur in up to Shock. 3. Very few patients have transient mild warmth and pain at the injection site when puncturing the vein or injecting contrast agent. In rare cases, convulsions have been observed after injection, with occasional transient Head Pain, vasodilation, dizziness, chills, and syncope have not been proven to be related to the use of this drug. Transient taste abnormality may occur on bolus injection. 4. Hypertonic injection may cause pain in the tissues around the blood vessels, which disappeared in about 20 minutes, and no adverse reactions were found in other tissues. |
| contraindication | Pacemaker and ferromagnetic implant carriers were contraindicated. |
| precautions | 1. Patients with allergic tendency should be used with special caution. Because the chance of allergic reaction is higher than other patients. 2. For patients with severe renal dysfunction, the decision to use before special caution, weighing the pros and cons, because the discharge of contrast agent will be delayed, in addition, so far known, this product will not affect renal function, even so, in patients with extremely severe renal dysfunction, hemodialysis is recommended to exclude drugs from the body. Some patients with serum iron and bilirubin increased slightly, but asymptomatic, can be very quickly recovered within 24 hours. 4. Serum iron was determined by complexation quantification within 24 hours of the enhanced scan, and the results may be very low due to the presence of diethylenetriaminepentaacetic acid (DTPA) in the contrast solution. The safety of drug use in pregnant and lactating women is unclear. (2016-03-11) |
| toxic substance data | information provided by: pubchem.ncbi.nlm.nih.gov (external link) |
Last Update：2024-04-09 20:52:54
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Product Name: Gadoxetate Disodium Impurity 27 Visit Supplier Webpage Request for quotationCAS: 86050-77-3
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Multiple Specifications
Product Name: Gadopentetate dimeglumine Visit Supplier Webpage Request for quotationCAS: 86050-77-3
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
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