tk1320
Glipizide
CAS: 29094-61-9
Molecular Formula: C21H27N5O4S
tk1320 - Names and Identifiers
| Name | Glipizide |
| Synonyms | k4024 tk1320 exylurea Melizide GLIPIZIDE Glipizide Glipizibe Glucotrol GlucotrolXL GLYDIAZINAMIDE glipizide(usp) Glipizide Solution, 100ppm 1-cyclohexyl-3-((p-(2-(5-methylpyrazinecarboxamido)ethyl)phenyl)sulfonyl)ure n-(4-(beta-(5-methylpyrazine-2-carboxamido)ethyl)benzenesulphonyl)-n'-cycloh urea,1-cyclohexyl-3-((p-(2-(5-methylpyrazinecarboxamido)ethyl)phenyl)sulfonyl) N-(2-{4-[(cyclohexylcarbamoyl)sulfamoyl]phenyl}ethyl)-5-methylpyrazine-2-carboxamide N-[2-[4-(cyclohexylcarbamoylsulfamoyl)phenyl]ethyl]-5-methyl-piperazine-2-carboxamide N-[2-[4-[[[(Cyclohexylamino)carbonyl]amino]sulfonyl]phenyl]ethyl]5-methylpyrazinecarboxamide N-[2-[4-[[[(cyclohexylamino)carbonyl]amino]sulfonyl]phenyl]ethyl]-5-methyl-2-pyrazinecarboxamide |
| CAS | 29094-61-9 |
| EINECS | 249-427-6 |
| InChI | InChI=1/C21H33N5O4S/c1-15-13-24-19(14-23-15)20(27)22-12-11-16-7-9-18(10-8-16)31(29,30)26-21(28)25-17-5-3-2-4-6-17/h7-10,15,17,19,23-24H,2-6,11-14H2,1H3,(H,22,27)(H2,25,26,28) |
tk1320 - Physico-chemical Properties
| Molecular Formula | C21H27N5O4S |
| Molar Mass | 445.54 |
| Density | 1.34±0.1 g/cm3(Predicted) |
| Melting Point | 208-209°C |
| Boling Point | 676.0±65.0 °C at 760 mmHg |
| Water Solubility | methanol: 1.9 mg/mL |
| Solubility | Soluble in water |
| Appearance | White or off-white crystalline powder |
| Color | white |
| Merck | 14,4442 |
| pKa | pKa 5.9 (Uncertain) |
| Storage Condition | 2-8°C |
| Refractive Index | 1.597 |
| MDL | MFCD00072159 |
| Physical and Chemical Properties | Appearance: white or off-white crystalline powder |
| Use | Antidiabetic agents for non-insulin-dependent (type II) Diabetes mellitus |
tk1320 - Risk and Safety
| Risk Codes | R21 - Harmful in contact with skin R36/38 - Irritating to eyes and skin. R46 - May cause heritable genetic damage R62 - Possible risk of impaired fertility R63 - Possible risk of harm to the unborn child |
| Safety Description | S24/25 - Avoid contact with skin and eyes. S53 - Avoid exposure - obtain special instructions before use. S36/37 - Wear suitable protective clothing and gloves. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S25 - Avoid contact with eyes. |
| WGK Germany | 3 |
| RTECS | YS7640000 |
| FLUKA BRAND F CODES | 10 |
| HS Code | 29350090 |
| Toxicity | LD50 in mice, rats (g/kg): >3, 1.2 i.p. (Ambrogi) |
tk1320 - Reference
| Reference Show more | Wang Ya-lan, Ma Zhang-qing. Effect of losartan on the pharmacokinetics of glipizide in type 2 diabetic rats [J]. Modern Medicine & Clinic, 2020, 035(002):P.216-221. |
tk1320 - Standard
Authoritative Data Verified Data
This product is 5-methyl-N-2[4-[[[(cyclohexylamino) carbonyl] amino] sulfonyl] phenyl] ethyl]-pyrazinecarboxamide. The content of C21H27N504S shall be 98.0% ~ 102.0% calculated as dry product.
Last Update：2024-01-02 23:10:35
tk1320 - Trait
Authoritative Data Verified Data
- This product is white or white crystalline powder; Odorless.
- This product is soluble in N,N-dimethylformamide, slightly soluble in acetone, chloroform, dioxane or methanol, very slightly soluble in ethanol, almost insoluble in water; soluble in dilute sodium hydroxide solution.
melting point
The melting point of this product (General 0612) is 203~208°C.
Last Update：2022-01-01 15:36:03
tk1320 - Differential diagnosis
Authoritative Data Verified Data
- take about 50mg of this product, add 5ml of dioxane, add 1ml of 0.5% 2, 4-dinitrofluorobenzene dioxane solution, boil for 2-3 minutes, and the solution will appear bright yellow.
- take this product, dissolve and dilute with methanol to make a solution containing about 20% per 1 ml, and measure it by UV-Vis spectrophotometry (General 0401), there is a maximum absorption at the wavelengths of 226nm and 274nm, and the absorbance ratio of the two absorption peaks is 2.0 to 2.4.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 808).
- 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.
Last Update：2022-01-01 15:36:04
tk1320 - Exam
Authoritative Data Verified Data
Related substances
take about 25mg of this product, weigh it accurately, put it in a 50ml measuring flask, add 25ml of methanol to dissolve it, use O. Dilute 1 mol / L sodium dihydrogen phosphate solution to the scale, shake well, as a test solution; Take 1ml with precision, put it in a 100ml measuring flask, dilute to the scale with mobile phase, shake well, 4-[2-(5-methylpyrazine-2-formylamino) ethyl] benzenesulfonamide (impurity I) control about 12.5mg, put it in a 50ml measuring flask, add methanol to dissolve and dilute to the scale, shake well, take 1ml accurately, put it in a 100ml measuring flask, dilute it to the scale with mobile phase, shake well, and use it as a reference solution. According to the chromatographic conditions under the content determination item, 20ul of the test solution, the control solution and the reference solution are respectively injected into the liquid chromatograph, the chromatogram was recorded to 2 times of the retention time of the main component peak. If there are chromatographic peaks in the chromatogram of the test solution that are consistent with the retention time of the main peak of the reference solution, the peak area shall be calculated according to the external standard method, and shall not exceed 0.5%; the Peak area of other single impurities shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution; The sum of the peak areas of other impurities shall not be greater than the main peak area of the control solution (1.0%).
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update：2022-01-01 15:36:04
tk1320 - 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 a filler; 0.1 mol/L sodium dihydrogen phosphate solution (adjusted to PH 6.00±0.05 with mol/L sodium hydroxide solution)-methanol (55:45) as mobile phase; The detection wavelength was 225nm. Take pioglitazone reference and impurity I reference, add methanol to dissolve and dilute to make mixed solution containing 0.5mg and 2.5ug per 1 mL respectively, and inject 20ul into the liquid chromatograph, the number of theoretical plates shall not be less than 2000 calculated by glipizide peak, and the separation degree between glipizide peak and impurity I peak shall meet the requirements.
assay
take about 25mg of this product, precision weighing, put it in 50ml measuring flask, add an appropriate amount of methanol, shake to dissolve and dilute to the scale, shake well, take 5ml precision, put 50ml measuring flask, add 20ml methanol, use 0.1 mol / L sodium dihydrogen phosphate solution was diluted to the scale, and then shaken well. As a test solution, 20ul was injected into the liquid chromatograph with precise amount, and the chromatogram was recorded. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 15:36:05
tk1320 - Category
Authoritative Data Verified Data
hypoglycemic drugs.
Last Update：2022-01-01 15:36:05
tk1320 - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:36:05
tk1320 - GlipizideTablets
Authoritative Data Verified Data
This product contains glipizide (C21H27N504S) should be 90.0% to 110.0% of the label.
trait
This product is white tablet or film-coated tablet.
identification
- take an appropriate amount of fine powder of this product (about 50mg equivalent to glipizide), add 0.5% dioxane, heat and shake in a water bath to dissolve glipizide, filter, add 2, 4-dinitrofluorobenzene dioxane solution 1ml, boiling for 2-3 minutes, the solution bright yellow.
- 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 fine powder of this product, add an appropriate amount of methanol, shake to dissolve glipizide and dilute with methanol to make a solution containing about 20% of glipizide per 1 ml, filter, the filtrate was measured by UV-Vis spectrophotometry (General 0401), and the maximum absorption was found at the wavelengths of 226nm and 274nm.
examination
- Related substances take an appropriate amount of fine powder of this product (about 25mg equivalent to glipizide), weigh it accurately, put it in a 50ml measuring flask, add 25ml of methanol, shake it to dissolve the pioglitazone, use 0. Dilute 1 mol / L sodium dihydrogen phosphate solution to the scale, shake well, filter, and take the filtrate as the test solution. Take 1ml in a 100ml measuring flask, dilute to the scale with mobile phase, another 12.5mg of reference product of impurity I was weighed accurately, placed in a 50ml measuring flask, dissolved in methanol and diluted to the scale, in a 100ml measuring flask, add the mobile phase to dilute to the scale, shake well, and use as a reference solution. Determination of glipizide related substances according to the method under. If there are chromatographic peaks in the chromatogram of the test solution that are consistent with the retention time of the main peak of the reference solution, the peak area shall be calculated according to the external standard method, and 1.0% of the labeled amount of glipizide shall not be passed; the sum of the peak areas of other impurities shall not be greater than 2 times (2.0%) the area of the main peak of the control solution.
- Content uniformity: Take 1 tablet of this product, grind it finely, and transfer it to 50ml (2.5mg specification) or lOOml(5mg specification) in fractions with methanol 25ml(2.5mg specification) or 50ml ( 5mg specification). In the measuring flask, the glipizide was dissolved by ultrasound and O. Dilute 1 mol / L sodium dihydrogen phosphate solution to the scale, shake well, filter, and take the continued filtrate as the test solution. According to the method under the content determination item, the content shall be measured and calculated according to law, and shall comply with the regulations (General rule 0941).
- dissolution the dissolution of this product was determined according to the dissolution and release determination method (General rule 0931, the first method), and the phosphate buffer (pH 7.4) was used as the dissolution medium, and the rotation speed was 100 rpm, operate according to law, after 30 minutes, take 10ml solution, filter, take the filtrate, according to UV-visible spectrophotometry (General rule 0401 ), at the wavelength of 222nm absorbance were measured; another 20mg glipizide reference was added into a 200ml measuring flask, and then 20ml of methanol was added to the flask. The solution was dissolved by shaking, diluted to the scale with phosphate buffer solution (pH 7.4) and shaken well, take 5ml accurately, put it in a 100ml measuring flask (2.5mg specification) or a 50ml measuring flask (5mg specification), dilute to the scale with squamous buffer (pH 7.4), shake well, and measure with the same method, the dissolution amount of each tablet was calculated. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- 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, precision weighing fine powder (about 5mg equivalent to glipizide), put it in a 100ml measuring flask, add methanol 50ml, ultrasonic to dissolve glipizide, use 0. Dilute 1 mol / L sodium dihydrogen phosphate solution to the scale, shake well, filter, take the filtrate as a test solution, and measure it according to the method under the item of glipizide content determination.
category
pioglitazone homolog.
specification
(1)2.5mg (2)5mg
storage
light-shielded, sealed, and stored in a dry place.
Last Update：2022-01-01 15:36:06
tk1320 - Glipizide capsules
Authoritative Data Verified Data
This product contains glipizide (C21H27N504S) should be 90.0% to 110.0% of the label.
trait
The content of this product is white or white 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 an appropriate amount of the contents of this product, add methanol to dissolve and dilute to make a solution containing 20ug glipizide per lml, filter, take the filtrate and measure it by UV-Vis spectrophotometry (General rule 0401), there is a maximum absorption at wavelengths of 226nm and 274nm.
examination
- Related substances take an appropriate amount of the content of this product (about 25mg equivalent to pioglitazone), put it in a 50ml measuring flask, add 25ml of methanol to dissolve glipizide, and use 0. Dilute 1 mol / L sodium dihydrogen phosphate solution to the scale, shake well, filter, and take the filtrate as the test solution. Take 1ml in a 100ml measuring flask, dilute to the scale with mobile phase, another 12.5mg of reference product of impurity I was added into a 50ml measuring flask, dissolved in methanol and diluted to the scale. Then, the mixture was shaken and measured accurately to obtain 1ml, set in a 100ml measuring flask, dilute to the scale with the mobile phase, and shake to serve as a reference solution. If there are chromatographic peaks in the chromatogram of the test solution with the same retention time as the main peak of the reference solution, the peak area shall be calculated according to the external standard method, 1.0% of the labeled amount of glipizide shall not be exceeded; The sum of the peak areas of other impurities shall not be greater than 2 times (2.0%) of the main peak area of the control solution.
- Content uniformity take 1 capsule of this product, pour the contents into 100ml(5mg specification) or 50ml(2.5mg specification) measuring flask, capsule shell with methanol 50ml(5mg specification) or 25ml(2.5mg specification) wash, lotion into the measuring flask, ultrasonic dissolution of glipizide, with 0. Dilute 1 mol / L sodium dihydrogen phosphate solution to the scale, shake well, filter, take the filtrate as a test solution, according to the method under the content determination, according to the law, calculate the content, the provisions shall be met (General rule 0941).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), with phosphate buffer (pH 7.8~8.0) 500ml as the dissolution medium, the rotation speed is 75 rpm, and the operation is carried out according to law. After 30 minutes, take an appropriate amount of the solution, filter it, and take the filtrate as the test solution, in a 100ml measuring flask, Add 10ml of methanol to dissolve, dilute to the scale with phosphate buffer (pH 7.8~8.0), shake well, take 5ml of precision measurement, set ml(5mg specification) or 7.8 ML (8.0 mg specification) flask, diluted to the scale with squamous buffer (pH ~), shake, as a control solution. According to the method under the content determination item, the dissolution amount of each particle was calculated by the peak area according to the external standard method. The limit is 80% 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 20 capsules of this product, precision weighing, mix the contents evenly, precision weighing an appropriate amount (about 5mg equivalent to glipizide), put it in a 100ml measuring flask, add 50ml of methanol, ultrasound to dissolve glipizide, with 0. Dilute 1 mol / L sodium dihydrogen phosphate solution to the scale, shake well, filter, take the filtrate as a test solution, and measure it according to the method under the item of glipizide content determination.
category
with glipizide.
specification
(1)2.5mg (2)5mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:36:07
tk1320 - Glipizide sustained-release gel
Authoritative Data Verified Data
This product contains pioglitazone (C21H27N504S) should be 90.0% ~ 110.0% of the label amount.
trait
The content of this product is white spherical particles.
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 in the contents of this product, dissolve it in methanol and dilute it to make a solution containing about 20% of glipizide per lml, filter it, and take the filtrate according to UV-Vis spectrophotometry (General 0401) the maximum absorption was measured at a wavelength of 226nm and 274nm.
examination
- Related substances take an appropriate amount of fine powder of the content of this product (about 25mg equivalent to glipizide), weigh it accurately, put it in a 50ml measuring flask, add 25ml of methanol, shake to dissolve glipizide, use 0. Dilute 1 mol / L sodium dihydrogen phosphate solution to the scale, shake well, filter, and take the filtrate as the test solution. Take 1ml in a 100ml measuring flask, dilute to the scale with mobile phase, another impurity I control product (12.5mg) was added to a 50ml measuring flask, methanol was added to dissolve and dilute to the scale, set in a 100ml measuring flask, dilute to the scale with the mobile phase, and shake to serve as a reference solution. If there are chromatographic peaks in the chromatogram of the test solution with the same retention time as the main peak of the reference solution, the peak area shall be calculated according to the external standard method, 0.5% of the labeled amount of glipizide shall not be passed; The peak area of other individual impurities shall not be greater. 0.5 times (0.5%) of the main peak area of the control solution, and the sum of the peak areas of other impurities shall not be greater than the main peak area of the control solution (1.0%). The chromatogram of the test solution is 0.05 times smaller than the main peak area of the control solution.
- Content uniformity take 1 capsule of this product, pour the content into a 100ml(5mg specification) or 200ml ( 10mg specification) measuring flask, and add 50ml of Methanol (5mg specification) or lOOml( lOmg specifications), ultrasound to dissolve glipizide, plus 0. Dilute 1 mol / L sodium dihydrogen phosphate solution to the scale, shake well, filter, take the filtrate as a test solution, according to the method under the content determination, according to the law, calculate the content, the provisions shall be met (General rule 0941).
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with phosphate buffer solution (pH 7.4±0 .05) 600ml is the dissolution medium, and the rotation speed is 75 revolutions per minute, and the operation is carried out according to law. After 1 hour, 4 hours and 8 hours, 5ml of the solution is taken and filtered respectively, immediately make up the dissolution medium of the same temperature and the same volume, according to the chromatographic conditions under the content determination item, take 20ul of the continuous filtrate, inject it into the liquid chromatograph, record the chromatogram, and take 20mg of the reference substance of glipizide, precision weighing, set in 100ml measuring flask, add 10ml methanol to dissolve, dilute with dissolution medium to scale, shake; Precision measure 2ml, set 50ml(5mg specification) or 25ml(10mg specification) flask, diluted with dissolution medium to the scale, shake, the same method. The elution amount of each particle at different times was calculated separately. The dissolution amount of each capsule of this product in 1 hour, 4 hours and 8 hours shall be 20% ~ 40%, 50% ~ 70% and more than 70% of the labeled amount, and shall comply with the regulations.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
take the contents of 20 capsules of this product, precise weighing, fine grinding, precise weighing fine powder appropriate amount (equivalent to 10mg of pioglitazone), put in 200ml measuring flask, add 100ml of methanol, ultrasound to dissolve glipizide, with 0. Dilute 1 mol / L sodium dihydrogen phosphate solution to the scale, shake well, filter, take the filtrate as a test solution, and measure it according to the method under the item of glipizide content determination.
category
pioglitazone homolog.
specification
(l ) 5mg (2)10mg
storage
light-shielded, sealed, and stored in a dry place.
Last Update：2022-01-01 15:36:08
Supplier List
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Product Name: Glipizide Visit Supplier Webpage Request for quotationCAS: 29094-61-9
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Multiple SpecificationsSpot supply
Product Name: Glipizide Visit Supplier Webpage Request for quotationCAS: 29094-61-9
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
Spot supply
Product Name: Glipizide Visit Supplier Webpage Request for quotationCAS: 29094-61-9
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Multiple SpecificationsSpot supply
Product Name: Glipizide Visit Supplier Webpage Request for quotationCAS: 29094-61-9
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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