LeucovorinCalcium - Names and Identifiers
Name | Calcium folinatc
|
Synonyms | calcium folinate Calcium folinatc LeucovorinCalcium L-Calcium Folinate Calcium leucovorin Calcium L-Folinate Leucovorin Calcium Calcium Folinate Hydrate Folinic acid calcium salt Folinic acid Calcium salt Folinic acid calcium salt USP28 calcium5-formyltetrahydrofolate FOLINIC ACID, CALCIUM SALT UPS28 CALCIUM FOLINATE(FOLINIC ACID)(RG) Calcium folinate, Leucovorine calcium calcium2-[4-[(2-amino-5-formyl-4-oxo-1,6,7,8-tetrahydropteridin-6-yl)methylamino]benzoyl] aminopentanedioate calcium (2S)-2-[(4-{[(2-amino-5-formyl-4-oxo-1,4,5,6,7,8-hexahydropteridin-6-yl)methyl]amino}benzoyl)amino]pentanedioate calcium (2S)-2-({[4-({[(6S)-2-amino-5-formyl-4-oxo-1,4,5,6,7,8-hexahydropteridin-6-yl]methyl}amino)phenyl]carbonyl}amino)pentanedioate 5-Formyl-5,6,7,8-tetrahydrofolic acid calcium salt, 5-HCO-H4PteGlu, Calcium folinate, Citrovorum factor calcium salt, Leucovorin calcium salt, 5-Formyl-5,6,7,8-tetrahydropteroyl-L-glutamic acid calcium salt
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CAS | 1492-18-8
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EINECS | 216-082-8 |
InChI | InChI=1/C20H23N7O7.Ca/c21-20-25-16-15(18(32)26-20)27(9-28)12(8-23-16)7-22-11-3-1-10(2-4-11)17(31)24-13(19(33)34)5-6-14(29)30;/h1-4,9,12-13,22H,5-8H2,(H,24,31)(H,29,30)(H,33,34)(H4,21,23,25,26,32);/q;+2/p-2/t12-,13-;/m0./s1 |
LeucovorinCalcium - Physico-chemical Properties
Molecular Formula | C20H25CaN7O7
|
Molar Mass | 515.54 |
Melting Point | >300°C |
Solubility | Sparingly soluble in water, practically insoluble in acetone and in ethanol (96 per cent). |
Appearance | Yellow crystalline powder |
Color | Pale Yellow to Light Yellow |
BRN | 5723924 |
Storage Condition | Keep in dark place,Inert atmosphere,Room temperature |
Stability | Hygroscopic |
MDL | MFCD00006704 |
Use | It is mainly used as an antidote for folic acid antagonists such as methotrexate, pyrimethamine or trimethoprim.
2. For the Prevention of methotrexate overdose or high-dose treatment caused by serious toxic effects.
3. Megaloblastic anemia caused by folic acid deficiency.
4. When combined with fluorouracil, it is used for the treatment of advanced colon cancer and rectal cancer. |
LeucovorinCalcium - Risk and Safety
Hazard Symbols | Xn - Harmful
|
Risk Codes | R36/37/38 - Irritating to eyes, respiratory system and skin.
R42/43 - May cause sensitization by inhalation and skin contact.
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Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
S36 - Wear suitable protective clothing.
S36/37 - Wear suitable protective clothing and gloves.
S22 - Do not breathe dust.
S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.)
|
WGK Germany | 3 |
RTECS | MA0600500 |
FLUKA BRAND F CODES | 3-8-10-23 |
HS Code | 29362900 |
LeucovorinCalcium - Standard
Authoritative Data Verified Data
This product is N-[4-[(2-amino -5-formyl -1,4,5,6,7, 8-hexahydro-4-oxo-6-pteridinyl) methyl] amino] Benzoyl-L-glutamic acid calcium salt pentahydrate. The C20H21CaN707 content should range from 95.0% to 102.0% based on the water content.
Last Update:2024-01-02 23:10:35
LeucovorinCalcium - Trait
Authoritative Data Verified Data
- This product is white to yellowish crystalline or amorphous powder; Odorless.
- This product is dissolved in water, almost insoluble in ethanol or ether; Dissolved in O.lmol/L sodium hydroxide solution.
Last Update:2022-01-01 11:43:56
LeucovorinCalcium - Differential diagnosis
Authoritative Data Verified Data
- 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 this product, add O. 1 mol/L sodium hydroxide solution is dissolved and made into a solution containing about 10ug per 1 ml, which is determined by ultraviolet-visible spectrophotometry (General 0401) and has a maximum absorption at the wavelength of 282nm, there is minimal absorption at a wavelength of 241NM.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 737) or with that of the control. In case of inconsistency, dissolve the reference sample and the test sample respectively with water (water as little as possible), Dropwise add acetone to produce a sufficient amount of precipitation, place for 15 minutes, centrifuge, and wash the precipitate twice with a small amount of acetone, dry, with the residue to draw infrared light absorption spectrum, should be consistent with the provisions (General 0402).
- identification reaction of calcium salt in aqueous solution of this product (General rule 0301).
Last Update:2022-01-01 11:43:56
LeucovorinCalcium - Exam
Authoritative Data Verified Data
pH
take 1.25g of this product, add 50ml of water to dissolve it, and determine it according to law (General rule 0631). The pH value should be 6.8~8.0.
Related substances
take this product, add water to dissolve and make a solution containing about 1 mg per 1 ml, as a test solution; Take appropriate amount of precision, A solution containing 10ug per 1 ml was prepared as a control solution by quantitative dilution with water. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution and the control solution are respectively injected into the liquid chromatograph, and the chromatogram is recorded to 3 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0% ) , the sum of each impurity peak area shall not be greater than 2.5 times (2.5%) of the main peak area of the control solution.
residual solvent
take 0.2g of this product, precision weighing, in the top empty bottle, precision add water 5ml to dissolve, seal, as a test solution; Precision weighing methanol and ethanol appropriate amount, A mixed solution containing about 0.12mg of methanol and 0.4mg of ethanol per 1 ml was prepared by quantitative dilution with water, and 5ml was accurately weighed, placed in a headspace bottle, sealed, and used as a reference solution. According to the test for determination of residual solvents (General rule 0861, Method 1), polyethylene glycol (PEG-20M) was used as stationary liquid, the column temperature was 50°C, and the inlet temperature was 200°C, the detector temperature was 250°C. The Headspace bottle equilibration temperature was 70°C and the equilibration time was 30 minutes. The test solution and the reference solution were sampled by Headspace injection, and the chromatograms were recorded. Calculated by peak area according to external standard method, the content of methanol shall not exceed 0.3%, and the content of ethanol shall not exceed 1.0%.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 16.0%.
Heavy metals
take this product 0.40g, inspection according to law (General Principles 0821 second law), containing heavy metals shall not exceed 50 parts per million.
Last Update:2022-01-01 11:43:57
LeucovorinCalcium - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel was bonded with OCTA alkyl silane as filler; Disodium hydrogen phosphate buffer solution containing 0.1% tetrabutylammonium hydroxide (10% aqueous solution of 2.2 tetrabutylammonium hydroxide and g of disodium hydrogen phosphate) was dissolved in water to make, the pH value was adjusted to 7.8 with phosphoric acid)-methanol (78:22) as the mobile phase; The column temperature was 40 ° C.; The detection wavelength was 280mn. The number of theoretical plates shall not be less than 2000 as calculated from the folinic acid peak.
assay
take an appropriate amount of this product, weigh it accurately, add water to dissolve and quantitatively dilute it to make it contain about 0 in each lml. 1 mg solution, as the test solution, the precise amount of 10u1 is injected into the liquid chromatograph, the chromatogram is recorded; The calcium folinate reference substance is also taken, the same method is determined, and the peak area is calculated according to the external standard method.
Last Update:2022-01-01 11:43:58
LeucovorinCalcium - Category
Authoritative Data Verified Data
antidotes and anti-anemia drugs.
Last Update:2022-01-01 11:43:58
LeucovorinCalcium - Storage
Authoritative Data Verified Data
shade, seal, and store in a cool place.
Last Update:2022-01-01 11:43:58
LeucovorinCalcium - Calcium Folinate Tablets
Authoritative Data Verified Data
This product contains calcium folinate according to folinic acid (C20H21CaN707) calculation, should be 90.0% ~ 110.0% of the label amount.
trait
This product is white-like to yellow.
identification
- 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 this product fine powder, add 0.1 mol / L sodium hydroxide solution is dissolved and made into a solution containing about folinic acid lOug per 1 ml, filtered, and the filtrate is taken for determination by UV-Vis spectrophotometry (General rule 0401), there is a maximum absorption at a wavelength of 282nm and a minimum absorption at a wavelength of 241mn.
- take an appropriate amount of fine powder of this product (about 15mg equivalent to folinic acid), add 4ml of water, shake, filter, and the filtrate shows the identification reaction of calcium salt (General rule 0301).
examination
- Related substances take the fine powder of this product, add water to dissolve and make a solution containing about 1 mg of folinic acid per 1 ml, filter, and take the continued filtrate as the test solution; test according to the method under calcium folinate related substances. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0% ) , the sum of each impurity peak area shall not be greater than 2.5 times (2.5%) of the main peak area of the control solution.
- Content uniformity take 1 tablet of this product, put it in a 200ml measuring flask (15mg specification) or a 250ml measuring flask (25mg specification), add an appropriate amount of water, shake to dissolve calcium folinate, dilute to scale with water, shake well, filter, take 10ul of filtrate precisely, measure according to the method under the content determination item, and multiply the result by 0.9256, and meet the requirements (General 0941).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method), with water as the dissolution medium, the speed is 100 rpm, according to the law, after 30 minutes, the solution is filtered, and the filtrate is accurately taken and diluted quantitatively with 0.2mol/L sodium hydroxide solution to prepare a solution containing about folinic acid lOug per 1 ml, the absorbance is measured by UV-Vis spectrophotometry (General rule 0401) at a wavelength of 282nm, calculated as the absorption coefficient of C20H21CaN707 is 575, and the result is multiplied by 0.9256, the dissolution amount of each tablet was calculated. The limit is 75% of the labeled amount and shall be in accordance with the regulations,
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
Take 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 20mg equivalent to folinic acid), put it in a 200ml measuring flask, add an appropriate amount of water, shake to dissolve calcium folinate, dilute with water to the scale, shake, filter, take the filtrate as a test solution, according to the method under the determination of calcium folinate content, and the result is multiplied by 0.9256.
category
calcium folinate.
specification
Based on C20H21CaN707 (l)15mg (2)25Mg
storage
light shielding, sealed storage.
Last Update:2022-01-01 11:43:59
LeucovorinCalcium - Calcium folinate injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of calcium folinate. Calcium folinate, calculated as folinic acid (C20H21CaN707), shall be between 90.0% and 110.0% of the labeled amount.
trait
This product is a light yellow to yellow clear liquid.
identification
- 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 this product and use 0.lmol / L sodium hydroxide solution is diluted to prepare a solution containing about folinic acid lOug per lml, which is determined by ultraviolet-visible spectrophotometry (General rule 0401) and has the maximum absorption at the wavelength of 282nm, there is minimal absorption at a wavelength of 241mn.
- This product is the identification of calcium salt reaction (General 0301).
examination
- the pH value should be 6.5 to 8.5 (General 0631).
- Related substances this product is diluted with water to prepare a solution containing about 1 mg of folinic acid per 1 ml, which is used as a test solution (test according to the method under the item of calcium folinate related substances. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0% ) , the sum of each impurity peak area shall not be greater than 2.5 times (2.5%) of the main peak area of the control solution.
- bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per 1 mg of folinic acid should be less than 0.36EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take this product and make it quantitatively diluted with water to contain about 0. 1% folinic acid per 1 ml. 1 mg of the solution, as a test solution, was measured according to the method under the item of calcium folinate content measurement, and the result was multiplied by 0.9256.
category
calcium folinate.
specification
calculated by C20H21CaN707 (1) 3ml:30mg (2)5ml:50mg (3) 10ml:0.lg
storage
shading, cold preservation.
Last Update:2022-01-01 11:44:00
LeucovorinCalcium - Calcium Folinate Capsules
Authoritative Data Verified Data
This product contains calcium folinate according to folinic acid (C20H21CaN707) calculation, should be 90.0% ~ 110.0% of the label amount.
trait
The content of this product is white to yellow particles or powder.
identification
- 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 the contents of this product, add 0.1 mol / L sodium hydroxide solution is dissolved and made into a solution containing about 10ug folinic acid per 1 ml, filtered, and the filtrate is taken for determination by UV-Vis spectrophotometry (General rule 0401), there is a maximum absorption at a wavelength of 282nm and a minimum absorption at a wavelength of 241mn.
- take an appropriate amount of the content of this product (about 15mg equivalent to folinic acid), add 4ml of water, shake, filter, filtrate calcium salt identification reaction (General 0301).
examination
- Related Substances: take the contents of this product, add water to dissolve and make a solution containing about 1 mg of folinic acid per 1 ml, filter, and take the continued filtrate as the test solution, test according to the method under calcium folinate related substances. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0% ), the sum of each impurity peak area shall not be greater than 2.5 times (2.5%) of the main peak area of the control solution.
- 1 capsule of this product was added to a 250ml measuring flask, added with appropriate amount of water, shaken to dissolve calcium folinate, diluted with water to the scale, shaken, filtered, the filtrate 10 u1 shall be accurately measured according to the method under the content determination item, and the result shall be multiplied by 0.9256, which shall comply with the regulations (General rule 0941).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method), with water as the dissolution medium, the speed is 100 rpm, according to the law, after 30 minutes, the solution is filtered, and the filtrate is accurately taken and diluted quantitatively with 0.2mol/L sodium hydroxide solution to prepare a solution containing about 10ug folinic acid per 1 ml, measure the absorbance at the wavelength of 282mn by UV-Vis spectrophotometry (General rule 0401), calculate the absorption coefficient of C20H21CaN707 as 575, and multiply the result by 0.9256, the amount of dissolution of each pellet was calculated. The limit is 75% of the labeled amount and shall be in accordance with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
take the contents of 20 capsules of this product, precision weighing, mixing evenly, grinding fine, precision weighing an appropriate amount (about 20mg equivalent to folinic acid), put it in a 200ml measuring flask, and add an appropriate amount of water, the calcium folinate is dissolved by shaking, diluted to the scale with water, shaken well, filtered, measured by the method under the item of calcium folinate content determination, and multiplied by 0.9256.
category
calcium folinate.
specification
25mg (calculated as C20H21CaN707)
storage
light shielding, sealed storage.
Last Update:2022-01-01 11:44:01