Pamidronate Disodium, GCP-23339A, Aminomux, Aredia
Disodium Pamidronate
CAS: 109552-15-0;57248-88-1
Molecular Formula: C3H12NNaO7P2
Pamidronate Disodium, GCP-23339A, Aminomux, Aredia - Names and Identifiers
Pamidronate Disodium, GCP-23339A, Aminomux, Aredia - Physico-chemical Properties
| Molecular Formula | C3H12NNaO7P2 |
| Molar Mass | 259.07 |
| Melting Point | 300°C |
| Boling Point | 658.7°C at 760 mmHg |
| Flash Point | 352.2°C |
| Solubility | H2O: 28mg/mL |
| Vapor Presure | 3.79E-20mmHg at 25°C |
| Appearance | solid |
| Color | white |
| Merck | 14,7003 |
| Storage Condition | 2-8°C |
| Stability | Hygroscopic |
| Physical and Chemical Properties | Melting point 300°C |
| Use | For the treatment of hypercalcemia and osteoporosis |
| In vitro study | In human osteoblasts, Pamidronate increased OPG mRNA levels and protein secretion in a dose-dependent manner up to 2-to 3-fold, with maximal effect after 72 hours of 1 μm treatment. Pamidronate prevents the inhibitory effect of the glucocorticoid dexamethasone on OPG mRNA and protein production. Pamidronate induces type I collagen secretion and alkaline phosphatase activity up to 2-fold. Pamidronate has a more pronounced calcium-lowering effect than either titanium acid and clodronic acid) and provides normocalcaemic relief over a longer period of time. Pamidronate(APD) dose-dependently inhibited the uptake of calcium phosphate film by horse osteoclast-like cells with an IC50 of 0.58 μm. Pamidronate dose-dependently suppressed the number of osteoclast-like cells after 7 days of bone marrow culture. |
| In vivo study | Pamidronate significantly inhibited this increase below control levels in the distal femur and tibia of rats. Pamidronate significantly increased bone density and weight in sham and ovariectomized rats. Pamidronate inhibited all significant effects of growth hormone (GH) in growth hormone (GH) treated rats, which also reduced levels by IGF-I. Pamidronate itself increases bone density and weight of the tibia, reduces urinary DPD excretion. |
Pamidronate Disodium, GCP-23339A, Aminomux, Aredia - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R22 - Harmful if swallowed R48 - Danger of serious damage to health by prolonged exposure R41 - Risk of serious damage to eyes R37/38 - Irritating to respiratory system and skin. R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. |
| Safety Description | S22 - Do not breathe dust. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) |
| UN IDs | 3077 |
| WGK Germany | 3 |
| RTECS | SZ6525000 |
| HS Code | 29319090 |
| Hazard Class | IRRITANT |
Pamidronate Disodium, GCP-23339A, Aminomux, Aredia - Nature
Open Data Verified Data
Crystal, melting point 227~229 °c.
Last Update：2024-01-02 23:10:35
Pamidronate Disodium, GCP-23339A, Aminomux, Aredia - Preparation Method
Open Data Verified Data
The aqueous solution of chlorobenzene and β-aminopropionic acid was heated to 100 ° C., phosphorus trichloride was added dropwise with stirring, and the reaction was further incubated. After cooling to room temperature, hydrogen chloride gas was removed by chlorine gas. The chlorobenzene solution was separated and slowly dripped. The mixture was stirred and heated to 100 °c for reaction. The crystals were crystallized by freezing, filtered, and the phosphonic acid was obtained. Pamidronate was suspended in water, and sodium hydroxide was added dropwise. The crystals were cooled and precipitated, filtered, and the filter cake was treated to obtain pamidronate disodium pentahydrate.
Last Update：2022-01-01 09:24:23
Pamidronate Disodium, GCP-23339A, Aminomux, Aredia - Standard
Authoritative Data Verified Data
This product is disodium 3-amino -1-hydroxypropylidene diphosphonate pentahydrate. Calculated as dried product, the content of C3H9NNa207P2 shall not be less than 98.0%.
Last Update：2024-01-02 23:10:35
Pamidronate Disodium, GCP-23339A, Aminomux, Aredia - Trait
Authoritative Data Verified Data
- This product is white crystalline or crystalline powder; Odorless; Slightly hygroscopic.
- This product is dissolved in water, insoluble in ethanol; Soluble in sodium hydroxide solution.
Last Update：2022-01-01 13:35:18
Pamidronate Disodium, GCP-23339A, Aminomux, Aredia - Preparation solution concentration reference
| 1mg | 5mg | 10mg | |
|---|---|---|---|
| 1 mM | 2.709 ml | 13.546 ml | 27.092 ml |
| 5 mM | 0.542 ml | 2.709 ml | 5.418 ml |
| 10 mM | 0.271 ml | 1.355 ml | 2.709 ml |
| 5 mM | 0.054 ml | 0.271 ml | 0.542 ml |
Last Update：2024-01-02 23:10:35
Pamidronate Disodium, GCP-23339A, Aminomux, Aredia - Use
Open Data Verified Data
developed by the Swiss company Ciba-Geigy, launched in 1989. Potent inhibitors of Osteoclastic bone resorption. Sodium pamidronate inhibits the attachment of osteoclast precursors to bone and their transformation into mature, functional osteoclasts. Both in vivo and in vitro, it has a local and direct anti-bone resorption effect of the bone-bound bisphosphonate. For tumor hyperemia, Paget's disease, malignant tumor and normal blood calcium osteolytic bone metastasis, idiopathic osteoporosis. Significant effect, low side effects.
Last Update：2022-01-01 09:24:23
Pamidronate Disodium, GCP-23339A, Aminomux, Aredia - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, add 2ml of water, heat to dissolve, add 2mg of ninhydrin, heat, the solution appears blue to purple blue.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 778).
- identification reaction of sodium salt of this product (General rule 0301).
- take this product about O.lg, add anhydrous sodium carbonate 2G to the Crucible, mix well, heat and melt, let it cool, add 10ml of water to dissolve, filter, add nitric acid to make the filtrate acidic, identification reaction of phosphate (General rule 0301).
Last Update：2022-01-01 13:35:19
Pamidronate Disodium, GCP-23339A, Aminomux, Aredia - Exam
Authoritative Data Verified Data
alkalinity
take l.Og of this product, add 50ml of water to dissolve, and measure it according to law (General rule 0631). The pH value should be 7.3~8.3.
clarity and color of solution
take this product l.Og, add water 25ml after dissolution, the solution should be clear and colorless.
phosphite
take this product about 3.2g, precision weighing, put 250ml iodine bottle, add water 70ml to dissolve, add phosphate buffer (pH 7.3)(take sodium dihydrogen phosphate 6.9g, add water to dissolve into 500ml, add 0.1 mol/L sodium hydroxide solution 400ml, shake well) 20ml, with 6mol/L acetic acid solution to adjust the pH value to 7.3 0.2, precision Iodine titration solution (0.05mol/L) 20ml, shake well, after standing in the dark for 1 hour, add 0.5ml of 6mol/L acetic acid solution, immediately use sodium thiosulfate titration solution (0.1 mol/L) titration, to the near end point, add 2ml of starch indicator solution, continue titration to blue disappeared, and the titration result is corrected by blank test. Each 1 ml of Iodine titration solution (0.05mol/L) is equivalent to mg of NaH2P03. The content of NaH2P03 should not exceed 0.5%.
furnace alanine
take this product, precision weighing, water dissolution and quantitative dilution made in each lml containing about 3.0 mg of solution, take 2ml, put it in a 10ml measuring flask, add 3ml of water, 1.0ml of 5% sodium carbonate solution and 2, 4-dinitrofluorophenylacetonitrile solution (take 2, the appropriate amount of 4-dinitrofluorobenzene was dissolved in acetonitrile and diluted to prepare a solution containing 15mg of 2, 4-dinitrofluorobenzene per 1 ml) 2.0ml, shake well, after reacting in a water bath at 40°C for 2 hours, take it out, let it cool down, dilute it to the scale with water, shake it well, and use it as a test solution, water was added to dissolve and quantitatively diluted to prepare a solution containing about 9ug per 1 ml, and 2ml was accurately measured to prepare a reference solution by the same method. According to the high performance liquid chromatography (General 0512) test, with eighteen alkyl silane bonded silica gel as filler, 0.01mol/ L potassium dihydrogen phosphate buffer (with sodium hydroxide solution to adjust the pH to 7.0) -methanol (70:30) as the mobile phase, the column temperature is 40°C, the detection wavelength is 360nm, the number of theoretical plate is not less than 2000 according to the calculation of the peak of the alanine derivative. The sample solution and the reference solution were respectively 10 u1, injected into the human liquid chromatograph, and the chromatogram was recorded. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of the peak of the alanine derivative, the peak area shall be calculated according to the external standard method, and shall not exceed 0.3%.
loss on drying
take this product about 0.5g, at 160 deg C dry 20 hours, weight loss should be 23.0% ~ 25.0% (General 0831).
Heavy metals
take 1.0g of this product, add 23ml of water to dissolve, add 2ml of acetate buffer (pH 3.5), and check according to law (General rule 0821 first law), containing heavy metals shall not exceed 10 parts per million.
Last Update：2022-01-01 13:35:19
Pamidronate Disodium, GCP-23339A, Aminomux, Aredia - Content determination
Authoritative Data Verified Data
take this product about 0.25g, precision weighing, add water 70ml dissolved, according to the potential titration method (General rule 0701), with hydrochloric acid titration solution (0.1 mol/L) titration and the results of the titration were corrected with a blank test. Each 1 ml of hydrochloric acid titration solution (0.1 mol/ L corresponds to 27.91mg of C3H9N Na207P2.
Last Update：2022-01-01 13:35:20
Pamidronate Disodium, GCP-23339A, Aminomux, Aredia - Category
Authoritative Data Verified Data
calcium modulator.
Last Update：2022-01-01 13:35:20
Pamidronate Disodium, GCP-23339A, Aminomux, Aredia - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 13:35:20
Pamidronate Disodium, GCP-23339A, Aminomux, Aredia - Pamidronate Disodium Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of pamidronate disodium with an appropriate amount of mannitol. Disodium pamidronate anhydrous (C3H9NNa207P2) shall be present at 90.0% to 110.0% of the labeled amount.
trait
This product is a clear colorless liquid.
identification
- take 3ml of this product, add 2mg of ninhydrin, heat, the solution is blue to purple blue.
- 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.
examination
- the pH value should be 5.0 to 7.0 (General 0631).
- B-alanine precision measure 2ml of this product, and measure according to the method under the item of pamidronate disodium B- alanine. If there is a peak consistent with the retention time of the peak of P-alanine derivative in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and 0.3% of the labeled amount of anhydrous pamidronate disodium shall not be exceeded.
- sterile take this product, by membrane filtration method, rinse with 0.1% sterile peptone aqueous solution (each membrane is not less than 100ml ) , with Staphylococcus aureus as positive control bacteria, inspection in accordance with the law (General rule 1101), should comply with the provisions.
- bacterial endotoxin this product, according to the law inspection (General 1143), each 1 mg pamidronate disodium containing endotoxin amount should be less than 1.6EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- measured by Ion Chromatography (General 0513).
- chromatographic conditions and system suitability test with anion exchange column; 3mmol/ L oxalic acid solution as mobile phase, flow rate of 1.2 per minute; Detector for conductivity detector. The theoretical plate number is not less than 2000 calculated from the pamidronate disodium peak.
- precision measurement this product was quantitatively diluted with water to make a solution containing 0.45mg of anhydrous pamidronate disodium per lml. 25u1 was injected into the liquid chromatograph for precise measurement and the chromatogram was recorded, precision weighing, dissolved and quantitatively diluted with water to prepare a solution containing 0.45mg of anhydrous pamidronate disodium in each lml, and determined by the same method. According to the external standard method to calculate the peak area, that is.
category
with pamidronate disodium.
specification
5ml:15mg (C3H9NNa207P2)
storage
sealed storage.
Last Update：2022-01-01 13:35:21
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Spot supply
Product Name: Ibandronate Impurity 23 Visit Supplier Webpage Request for quotationCAS: 109552-15-0
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Multiple Specifications
Product Name: Pamidronate Disodium Visit Supplier Webpage Request for quotationCAS: 109552-15-0
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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