LANSOPRAZOLE

LANSOPRAZOLE - Names and Identifiers

Name	lansoprazole
Synonyms	OGAST PREVACID LANSOPRAZOLE lansoprazole LANSOPRAZOLE USP(CRM STANDARD) LANSOPRAZOLE, MM(CRM STANDARD) 2-(((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-1h-benz 1-(1H-benzimidazol-2-yl)-2-[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]ethanone 2-{[[3-methyl-4-(2,2,2-trifluoroethoxy)2-pyridinyl]methyl]sulfonyl}1H-benzimidazole 2-[3-METHYL-4-(2,2,2-TRIFLUORO-ETHOXY)-PYRIDIN-2-YLMETHANESULFINYL]-1H-BENZOIMIDAZOLE 2-({[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl}sulfinyl)-1H-benzimidazole LANSOPRAZOLE, RELATED COMPOUND A2-[[[3-METHYL-4-(2,2,2-TRIFLOUROETHOXY)-2-PYRIDYL]METHYL]SULFONYL]BENZIMIDAZOLE USP STANDARD
CAS	103577-45-3
EINECS	2017-001-1
InChI	InChI=1/C17H14F3N3O2/c1-10-13(21-7-6-15(10)25-9-17(18,19)20)8-14(24)16-22-11-4-2-3-5-12(11)23-16/h2-7H,8-9H2,1H3,(H,22,23)
InChIKey	MJIHNNLFOKEZEW-UHFFFAOYSA-N

LANSOPRAZOLE - Physico-chemical Properties

Molecular Formula	C16H14F3N3O2S
Molar Mass	369.36
Density	1.50±0.1 g/cm3(Predicted)
Melting Point	178-182°C dec.
Boling Point	555.8±60.0 °C(Predicted)
Flash Point	259.2°C
Solubility	Soluble in methanol, ethanol (14 mg/ml at 25 °C), DMF (~30 mg/ml), and DMSO (74 mg/ml
Vapor Presure	2.55E-10mmHg at 25°C
Appearance	White to pink crystals
Color	off-white
Merck	14,5362
pKa	pKa 2.34±0.37 (Occasionally);3.53±0.37 (Occasionally);8.48±0.30 (Occasionally)
Storage Condition	2-8°C
Refractive Index	1.591
MDL	MFCD00866873
Physical and Chemical Properties	Crystallization, melting point 178~182 C (decomposition).
Use	For the treatment of duodenal ulcer and other diseases

LANSOPRAZOLE - Risk and Safety

Hazard Symbols	Xi - Irritant
Risk Codes	36/37/38 - Irritating to eyes, respiratory system and skin.
Safety Description	S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36 - Wear suitable protective clothing.
WGK Germany	2
RTECS	DD9487500
HS Code	29339900

LANSOPRAZOLE - Standard

Authoritative Data Verified Data

This product is 2-[[[3-methyl -4-(2,2, 2-trifluoroethoxy)]-2-pyridyl] methyl] sulfinyl]-1H-benzimidazole. The content of C16H14F3N302S shall be between 98.0% and 102.0% calculated as dry.

Last Update：2024-01-02 23:10:35

LANSOPRAZOLE - Trait

Authoritative Data Verified Data

This product is white or off-white crystalline powder; Odorless, easy to deteriorate when exposed to light and air.
This product is soluble in N ,N-dimethylformamide, soluble in methanol, slightly soluble in ethanol, almost insoluble in water.

Last Update：2022-01-01 11:39:17

LANSOPRAZOLE - 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 an appropriate amount of this product, add methanol to dissolve and make a solution containing l0ug per lml, and measure it by UV-Vis spectrophotometry (General 0401), there is a maximum absorption at a wavelength of 284nm and a minimum absorption at a wavelength of 245Nm.
The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 708).

Last Update：2022-01-01 11:39:17

LANSOPRAZOLE - Exam

Authoritative Data Verified Data

Related substances

operation in the dark. Weigh about 50mg of this product, put it in 25ml measuring flask, and add O. 5ml of lmol/L sodium hydroxide solution and an appropriate amount of methanol were dissolved by shaking, diluted to the scale with methanol, and then shaken to be used as a sample solution, control Solutions (1) and (2) containing 20UG and lug of lansoprazole respectively per 1 ml were prepared by dilution with methanol. According to the chromatographic condition test under the content determination item, take 10ul of the control solution (2) and inject it into the liquid chromatograph. The signal-to-noise ratio of lansoprazole peak height should be greater than 10; the sample solution and the control solution (1) of 10ul were respectively injected into the human liquid chromatograph, and the chromatogram was recorded to 3.5 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 0.5 times (0.5%) of the area of the main peak of the control solution (1), the sum of each impurity peak area shall not be greater than the main peak area (1.0%) of the control solution (1). Test Solution chromatogram is smaller than the control solution (2) the main peak area of 0.5 times the chromatographic peaks are ignored.

loss on drying

take this product, with potassium hydroxide as desiccant, under reduced pressure drying to constant weight, weight loss should not exceed 0.5% (General rule 0831).

ignition residue

take l.Og of this product, check according to law (General rule 0841), not over 0.1%.

Heavy metals

The residue left under the item of taking the ignition residue shall not contain more than 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).

Last Update：2022-01-01 11:39:18

LANSOPRAZOLE - Content determination

Authoritative Data Verified Data

measured by high performance liquid chromatography (General 0512).

chromatographic conditions and system suitability test

silica gel bonded with eighteen alkyl silane as filler (4.6 × 600, 5um or equivalent column); Methanol-water-triethylamine-phosphoric acid (400: 1.5: 5:) [Adjustment of pH value to 7.3 with phosphoric acid solution (1-10)] as a mobile phase, the detection wavelength was 284nm. Take 10mg of lansoprazole and 10mg of M-chloroperoxybenzoic acid in the same 20ml measuring flask, dissolve in methanol-water (60:40) solution, dilute to the mark, and place for 10 minutes, 10ul injection liquid chromatograph, adjust the mobile phase ratio, so that the retention time of lansoprazole peak is about 16 minutes, lansoprazole and two main degradation product peaks (relative to the retention time of the main peak is about 0.6, 0.8) the separation degree should be greater than 3.0.

assay

take this product about 15mg, precision weighing, 100ml flask, add 0.1 mol /L sodium hydroxide solution 5M l and methanol-water (60:40) solution appropriate amount, ultrasonic to dissolve, dilute to the scale with methanol-water (60:40) solution, shake, filter, take the filtrate as the test solution, take the LOL injection into the human liquid chromatograph, record the chromatogram; Take the lansoprazole reference substance, the same method for determination. According to the external standard method to calculate the peak area, that is.

Last Update：2022-01-01 11:39:19

LANSOPRAZOLE - Category

Authoritative Data Verified Data

proton pump inhibitors.

Last Update：2022-01-01 11:39:19

LANSOPRAZOLE - Storage

Authoritative Data Verified Data

shading, sealing, storage in cold place.

Last Update：2022-01-01 11:39:19

LANSOPRAZOLE - Lansoprazole Enteric -coated Tablets

Authoritative Data Verified Data

This product should contain lansoprazole label amount of 95.0% ~ 105.0%.

trait

This product is an enteric-coated tablet, white to yellowish after removing the coating.

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 an appropriate amount of fine powder of this product, add methanol to dissolve and dilute to prepare a solution containing 10ug lansoprazole per lml, filter, and measure the filtrate by UV-Vis spectrophotometry (General rule 0401), there is an absorption maximum at a wavelength of 284nm.

examination

the related substances were protected from light. Take the appropriate amount of fine powder (about 50mg equivalent to lansoprazole) under the content determination item, put it in a 25ml measuring flask, and add 0.5ml of 1 mol/L sodium hydroxide solution and an appropriate amount of methanol were mixed, and the lansoprazole was dissolved by shaking. The solution was diluted with methanol to scale, shaken well, filtered with a 0.5um filter membrane, and the continued filtrate was taken as the test solution; control Solutions (1) and (2) containing 20UG and lug of lansoprazole, respectively, per 1 ml were prepared by dilution with methanol in an appropriate amount. The determination was carried out according to the method for related substances of lansoprazole. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 0.5 times (0.5%) of the area of the main peak of the control solution (1), the sum of each impurity peak area shall not be greater than 2 times (2.0%) the area of the main peak of the control solution (1). The chromatographic peaks of the test solution less than 0.5 times the main peak area of the control solution (2) and the chromatographic peaks before the relative retention time of 0.25 were ignored.
Content uniformity (15mg specification) take 1 tablet of this product, put it in a 100ml measuring flask, add 0.lmol/L sodium hydroxide solution 5ml ultrasonic to collapse, add methanol-water (60:40) solution appropriate amount, ultrasonic dissolution of lansoprazole, cool, with methanol-water (60:40) dilute the solution to the scale, filter or centrifuge, take the filtrate or supernatant as the test solution, and determine the content according to the method under the content determination item, which should comply with the regulations (General 0941).
dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method 2) determination, hydrochloric acid solution (9-1000)1000ml as the dissolution medium, the rotating speed is 100 rpm, and the operation is carried out according to law. After 120 minutes, the rotating basket is immediately raised out of the liquid surface, the hydrochloric acid solution is discarded, and of phosphate buffer solution (pH 6.8) preheated to 37C is immediately added, continue to operate according to the law, after 45 minutes, take the solution to filter, take the filtrate 5ml, add the 0.15mol/L sodium hydroxide solution 1 ml, shake, as a test solution; another precision weigh lansoprazole reference product about 15mg, put it in a 100ml measuring flask, add methanol to dissolve and dilute to the scale, shake well, take 5ml, put 50ml measuring flask (15mg specification) or 25ml measuring flask (30mg specification), with phosphate buffer (pH 6.8) diluted to the scale, shake, precision take 5ml, precision add 0.15mol/L sodium hydroxide solution 1 ml, shake well as a control solution. Take the test solution and the reference solution, according to the method under the content determination, calculate the dissolution of each tablet. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
If the average dissolution amount is not less than 90% of the labeled amount, the acid resistance is not measured. Take this product, according to the dissolution and release determination method (General rule 0931 The first method), with hydrochloric acid solution (9 - 1000) 1000ml as dissolution medium, speed of 100 rpm, method operation, after 120 minutes, the test piece is taken, the surface hydrochloric acid solution is washed with water, dried with filter paper, and placed in a ml measuring flask (15 mg specification) or a ml measuring flask (30mg specification), and 0.1 mol/L sodium hydroxide solution 5ml with methanol-water (60:40) solution about 30ml, ultrasonic dissolution of lansoprazole, let cool, with methanol-water (60:40) dilute the solution to the scale, shake well, filter (or centrifuge), take the continued filtrate (or upper solution) as the test solution, and determine it according to the method under the content determination item, the content of each tablet was calculated. The content of each of the 6 tablets shall not be less than 90% of the labeled amount; If 1~2 tablets are less than 90% of the labeled amount, but not less than 80% of the labeled amount, the average content shall not be less than 90% of the labeled amount; If 1-2 tablets are less than 90% of the labeled amount, of which only 1 tablet is less than 80% of the labeled amount, but not less than 70% of the labeled amount, the average content shall not be less than 90% of the labeled amount, and another 6 tablets shall be taken for re-examination; 1~3 of the 12 tablets in the initial and re-examination shall be less than 90% of the labeled amount, only 1 of them is less than 80% of the labeled amount, but not less than 70% of the labeled amount, and the average content shall not be less than 90% of the labeled amount.
loss on drying: take an appropriate amount of the fine powder of this product and weigh it accurately. Dry it under reduced pressure at 60 ° C. For 5 hours with potassium hydroxide as desiccant, and lose no more than 5.0% of the weight (General rule 0831).
others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).

Content determination

light-shielding operation. Determined by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler (4.6mm x 250mm,5pm or equivalent column); Methanol-water-triethylamine-phosphoric acid (600:400:5:1.5)[adjust pH to 7.3 with phosphoric acid solution (1-10)] as mobile phase, the detection wavelength was 284nm. Take about 10 mg of lansoprazole and about 10 mg of M-chloroperoxybenzoic acid, put them in the same 20ml measuring flask, dissolve with methanol-water (60:40) solution and dilute to the scale, place them for 10 minutes, louli was injected into the human liquid chromatograph, and the mobile phase ratio was adjusted so that the retention time of lansoprazole peak was about 16 minutes, and the retention time of lansoprazole and the two main degradation product peaks (relative to the retention time of the main peak was about 0.6, 0.8) the separation degree should be greater than 3.0.
determination of 20 tablets of this product, remove the enteric coating, precision weighing, fine grinding, precision weighing an appropriate amount (about 15mg equivalent to lansoprazole), put it in a 100ml measuring flask, add 0.1 mol/L sodium hydroxide solution 5ml and methanol-water (60:40) solution appropriate amount, ultrasonic to dissolve lansoprazole, let cool, dilute to the scale with methanol-water (60:40) solution, after shaking, filtering, the filtrate was taken as the test solution, and 10ul was accurately measured and injected into the human Liquid Chromatograph. The chromatogram was recorded, in a 100ml measuring flask, add 0.1 mol/L sodium hydroxide solution 5ml with methanol-water (60:40) solution appropriate amount, ultrasonic to dissolve, cool, dilute to the scale with methanol-water (60:40) solution, shake, the same method. According to the external standard method to calculate the peak area, that is.

specification

(l)15mg (2)30mg

storage

shade, seal, and store in a cool and dry place.

Last Update：2022-01-01 11:39:20

LANSOPRAZOLE - LansoprazoleforInjection

Authoritative Data Verified Data

This product is a sterile lyophilized product of lansoprazole. Lansoprazole (C16H14F3N302S) shall be included at 95.0% to 105.0% of the label load, calculated as the average loading.

trait

This product is white or off-white loose block 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 control solution.

examination

alkalinity this product is dissolved in water and diluted to prepare a solution containing 3mg of lansoprazole per 1 ml, which is measured according to law (General rule 0631). The pH value should be 10.5~12.5.
the clarity and color of the solution take 5 bottles of this product, add water separately to dissolve and dilute to prepare a solution containing lansoprazole 3mg per 1 ml, the solution should be clear and colorless; If the color is developed, no deeper than the yellow No. 2 Standard Colorimetric solution (General rule 0901 first method).
the related substances were protected from light. Take the contents under the difference of loading amount, mix well, weigh an appropriate amount (about 50mg of lansoprazole) accurately, put it in a 25ml measuring flask, add 0.5ml of lmol/L sodium hydroxide solution and an appropriate amount of methanol were dissolved by shaking, diluted to the scale with methanol, and then shaken to be used as a sample solution, control Solutions (1) and (2) containing 20UG and lug of lansoprazole respectively per 1 ml were prepared by dilution with methanol. The determination was carried out according to the method for related substances of lansoprazole. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 0.5 times (0.5%) of the area of the main peak of the control solution (1), the sum of each impurity peak area shall not be greater than the main peak area (1.0%) of the control solution (1). Test Solution chromatogram is smaller than the control solution (2) the main peak area of 0.5 times the chromatographic peaks are ignored.
the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 5.0%, first method 1).
the bacterial endotoxin of this product is taken and checked according to law (General rule 1143). The amount of endotoxin contained in lansoprazole per 1 mg should be less than 5.0EU.
sterile take this product, add 0.1% sterile peptone aqueous solution to dissolve, through membrane filtration method, rinse with 0.1% 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.
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 eighteen alkyl silane bonded silica gel as filler (4.6 mmX250mm,5um or equivalent column); Methanol-water-triethylamine-phosphoric acid (600:400:5:1.5)[adjust pH to 7.3 with phosphoric acid solution (1-10)] as mobile phase; Detection wavelength was 284nm. 10mg of lansoprazole and 10mg of M-peroxybenzoic acid, respectively, were placed in the same 20ml measuring flask, dissolved in methanol-water (60:40) solution, diluted to the scale, and placed for 10 minutes, lOul was injected into human liquid chromatograph, and the ratio of mobile phase was adjusted, so that the retention time of lansoprazole peak was about 16 minutes, lansoprazole and two main degradation product peaks (relative retention time of main peak was about 0.6 and 0.8 respectively). The degree of separation between should be greater than 3.0.
determination of content under the item of loading amount difference, mixed evenly, precision weighing appropriate amount (about 15mg equivalent to lansoprazole), put in a 100ml measuring flask, add 0.1 mol/L sodium hydroxide solution 5ml and methanol-water (60:40) solution about 30ml to dissolve, dilute to the scale with methanol-water (60:40) solution, shake, as a sample solution, the sample was accurately measured by injection of 10u1 into the human liquid chromatograph, and the chromatogram was recorded. Another reference substance of lansoprazole was taken and determined by the same method. According to the external standard method to calculate the peak area, that is.

specification

30mg

storage

It is kept in a closed, cool and dry place.

Last Update：2022-01-01 11:39:21

Jiangsu Pules Biotechnology Co.,Ltd.

Product Name: lansoprazole Request for quotation
CAS: 103577-45-3
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Jiangsu Pules Biotechnology Co.,Ltd.

Product Name: lansoprazole Request for quotation
CAS: 103577-45-3
Tel: 17505222756
Email: pules.cn@gmail.com
Mobile: +86-17551318830
Wechat: 17505222756

Nantong Reform Petro-Chemical CO., LTD.

Spot supply

Product Name: lansoprazole Request for quotation
CAS: 103577-45-3
Tel: +86-17551318830
Email: r@reformchem.com
Mobile: +86-17551318830
QQ: 3785839865

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Hubei YoungXin Pharmaceutical Tech Co.,Ltd.

Spot supply

Product Name: Lansoprazole Visit Supplier Webpage Request for quotation
CAS: 103577-45-3
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052

Wechat: 15671228036

Hefei TNJ Chemical Industry Co.,Ltd.

Product Name: lansoprazole Request for quotation
CAS: 103577-45-3
Tel: 0086-551-65418684
Email: sales@tnjchem.com
　　　　 info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840

Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog

Shanghai Yuanye Bio-Technology Co., Ltd.

Multiple SpecificationsSpot supply

Product Name: Lansoprazole Visit Supplier Webpage Request for quotation
CAS: 103577-45-3
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409

Wechat: 18301782025

Shanghai Worldyang Chemical Co.,Ltd.

Product Name: Lansoprazole Request for quotation
CAS: 103577-45-3
Tel: +86-21-56795779
Email: charles7788@worldyachem.com
Mobile: +86-13651600618
QQ: 2850607228

Wechat: 13651600618
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View History

LANSOPRAZOLE

LANSOPRAZOLE Request for Quotation

lansoprazole

CAS: 103577-45-3

Molecular Formula: C16H14F3N3O2S

LANSOPRAZOLE - Names and Identifiers

LANSOPRAZOLE - Physico-chemical Properties

LANSOPRAZOLE - Risk and Safety

LANSOPRAZOLE - Standard

Authoritative Data Verified Data

LANSOPRAZOLE - Trait

Authoritative Data Verified Data

LANSOPRAZOLE - Differential diagnosis

Authoritative Data Verified Data

LANSOPRAZOLE - Exam

Authoritative Data Verified Data

Related substances

loss on drying

ignition residue

Heavy metals

LANSOPRAZOLE - Content determination

Authoritative Data Verified Data

chromatographic conditions and system suitability test

assay

LANSOPRAZOLE - Category

Authoritative Data Verified Data

LANSOPRAZOLE - Storage

Authoritative Data Verified Data

LANSOPRAZOLE - Lansoprazole Enteric -coated Tablets

Authoritative Data Verified Data

trait

identification

examination

Content determination

category

specification

storage

LANSOPRAZOLE - LansoprazoleforInjection

Authoritative Data Verified Data

trait

identification

examination

Content determination

category

specification

storage

Supplier List

LANSOPRAZOLE