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107007-99-8

Granisetron Hydrochloride

CAS: 107007-99-8

Molecular Formula: C18H25ClN4O

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107007-99-8 - Names and Identifiers

Name Granisetron Hydrochloride
Synonyms KYTRIL
BRL-43694A
107007-99-8
Gransetron HCl
GRANISETRON HCL
GranisetronHclFda
midehydrochloride
endo-monohydrochlorid
endo-monohydrochloride
GRANISTRON HYDROCHLORIDE
Granisetron Hydrochloride
Granisetron hydrocholride
Granisertronhydrochloride
GRANISERTROL HYDROCHLORIDE
GranisetronHydrochlorideFdaInspected
1-methyl-n-(9-methyl-9-azabicyclo(3.3.1)non-3-yl)-1h-indazole-3-carboxamid
1-methyl-N-(9-methyl-9-azabicyclo[3.3.1]non-3-yl)-1H-indazole-3-carboxamide
endo-1-methyl-n-(9-methyl-9-azabicyclo(3.3.1)non-3-yl)-1h-indazole-3-carboxa
1-methyl-N-[(3-endo)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide
1-Methyl-N-(9-methyl-9-azabicyclo[3.3.1]nonan-3-yl)-1H-isoindole-3-carboxamide hydrochloride
1-METHYL-N-[(3-ENDO)-9-METHYL-9-AZABICYCLO[3.3.1]NON-3-YL]-1H-INDAZOLE-3-CARBOXAMIDE HYDROCHLORIDE
1-Methyl-N-[(1β,5β)-9-methyl-9-azabicyclo[3.3.1]nonane-3α-yl]-1H-indazole-3-carboxamide·hydrochloride
1-Methyl-N-[(1β,3α,5β)-9-methyl-9-azabicyclo[3.3.1]nonane-3-yl]-1H-indazole-3-carboxamide·hydrochloride
1H-Indazole-3-carboxamide, 1-methyl-N-(9-methyl-9-azabicyclo[3.3.1]non-3-yl)-, monohydrochloride, endo-
1H-Indazole-3-carboxamide, 1-methyl-N-[(3-endo)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-, monohydrochloride
BRL-43694A, Kytril, 1-Methyl-N-[(3-endo)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide Hydrochloride
CAS 107007-99-8
EINECS 634-603-0
InChI InChI=1/C18H24N4O/c1-21-13-6-5-7-14(21)11-12(10-13)19-18(23)17-15-8-3-4-9-16(15)22(2)20-17/h3-4,8-9,12-14H,5-7,10-11H2,1-2H3,(H,19,23)/t12-,13+,14-

107007-99-8 - Physico-chemical Properties

Molecular FormulaC18H25ClN4O
Molar Mass348.87
Density1.33g/cm3
Melting Point290-292°C
Boling Point532.016°C at 760 mmHg
Flash Point275.553°C
Solubility H2O: >10mg/mL
Vapor Presure0mmHg at 25°C
AppearanceWhite to white-like solid
Colorwhite to off-white
Merck14,4536
Storage ConditionRoom temp
Refractive Index1.69
MDLMFCD01747034
Physical and Chemical Properties

appearance

white crystalline powder

Content (HPLC) ≥99%
loss on drying ≤1.0%
pH 4.0~6.0
Heavy metals ≤20ppm
UseUsed as antispasmodic

107007-99-8 - Risk and Safety

Risk CodesR22 - Harmful if swallowed
R62 - Possible risk of impaired fertility
R37/38 - Irritating to respiratory system and skin.
R36/37/38 - Irritating to eyes, respiratory system and skin.
R36 - Irritating to the eyes
Safety DescriptionS26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
S36 - Wear suitable protective clothing.
S37 - Wear suitable gloves.
S24/25 - Avoid contact with skin and eyes.
WGK Germany3
RTECSNK7882200
HS Code29399990

107007-99-8 - Standard

Authoritative Data Verified Data

This product is 1-methyl-N-[9-methyl-Bridge -9-azabicyclo [3,3,1] nonan-3-yl]-1 indazole-3-carboxamide hydrochloride. Based on the dry product, the content of C18H24N40 • HCl should be between 98.0% and 102.0%.

Last Update:2024-01-02 23:10:35

107007-99-8 - Trait

Authoritative Data Verified Data
  • This product is white or off-white crystalline powder; Odorless.
  • This product is soluble in water, slightly soluble in methanol, slightly soluble in ethanol; Slightly soluble in 0.lmol/L hydrochloric acid solution.
Last Update:2022-01-01 15:33:07

107007-99-8 - Differential diagnosis

Authoritative Data Verified Data
  1. 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.
  2. take this product, add 0.lmol/L hydrochloric acid solution is dissolved and diluted to prepare a solution containing about 10ug per lml, which is determined by ultraviolet-visible spectrophotometry (General 0401) and has a maximum absorption at the wavelength of 302nm, there is minimal absorption at a wavelength of 251nm.
  3. The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1027).
  4. This product is chloride identification reaction (General 0301).
Last Update:2022-01-01 15:33:07

107007-99-8 - Exam

Authoritative Data Verified Data

acidity

take 0.10g of this product, Add 10ml of water to dissolve, and measure according to law (General rule 0631). The pH value should be 4.0~6.5.


clarity and color of solution

take 0.10g of this product, Add 10ml of water to dissolve, the solution should be clear and colorless.


sulfate

take 1.0g of this product and check it according to law (General rule 0802). Compared with the control solution made of 0.02% of standard potassium sulfate solution, it shall not be deeper ().


Related substances

take this product, add mobile phase to dissolve and dilute to make a solution containing about 0.5mg per lml, as a test solution, take an appropriate amount of precision, A solution containing 5ug per 1 ml was prepared as a control solution by quantitative dilution with the mobile phase. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution and the control solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded to 2 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area 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 15:33:08

107007-99-8 - Content determination

Authoritative Data Verified Data

measured by high performance liquid chromatography (General 0512).


chromatographic conditions and system suitability test

silica gel bonded with cyanosilane as filler; 0.25% mol/L sodium acetate solution containing 0.05 (ml/ml) triethylamine (adjusted to pH 6.0 with glacial acetic acid)-methanol (50:50) as mobile phase; The detection wavelength was 302nm. The number of theoretical plates is not less than 2000 based on the granisetron peak. Take appropriate amount of this product, add solvent (take phosphoric acid 0.16ml add water to 80ml, add acetonitrile 20ml, mix, add Hexylamine 0.1ml, adjust pH value to 7.5 with triethylamine) dissolve and dilute to make a solution containing about 0.5mg per 1ml, take an appropriate amount, put it in a test tube, plug it, and irradiate it under strong light for 4 hours as a system applicable solution, take 20u1 injection human liquid chromatograph, record chromatogram, granisetron peak should produce obvious light degradation product peak, granisetron peak and light degradation product peak separation degree should meet the requirements.


assay

take the right amount of this product, precision weighing, plus mobile phase dissolution and quantitative dilution made in each lml containing about 0.1 mg solution, as a test solution, the precision of 20u1 injection of human liquid chromatography, recording chromatogram; Another granisetron hydrochloride 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 15:33:09

107007-99-8 - Category

Authoritative Data Verified Data

adjuvant antineoplastic drugs.

Last Update:2022-01-01 15:33:09

107007-99-8 - Storage

Authoritative Data Verified Data

light shielding, sealed storage.

Last Update:2022-01-01 15:33:09

107007-99-8 - Granisetron Hydrochloride Tablets

Authoritative Data Verified Data

This product contains granisetron hydrochloride in accordance with granisetron (C18H24N40), should be 90.0% ~ 110.0% of the label amount.


trait

This product is white or off-white.


identification

  1. 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.
  2. take an appropriate amount of fine powder of this product and add 0.1 mol/L hydrochloric acid solution granisetron hydrochloride was dissolved and diluted to prepare a solution containing granisetron lOug per 1 ml, which was determined by UV-Vis spectrophotometry (General 0401), there is a maximum absorption at a wavelength of 302mn and a minimum absorption at a wavelength of 251nm.
  3. Take appropriate amount of fine powder of this product, add water, shake, filter, filtrate chloride to identify (1) reaction (General rule 0301).

examination

  • Related Substances: Take appropriate amount of fine powder of this product, add mobile phase to dissolve and dilute granisetron hydrochloride to make a solution containing about 0.5mg of granisetron per 1 ml, and filter it through, the continued filtrate was taken as the test solution. According to the method of granisetron hydrochloride related substances. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
  • Content uniformity take 1 tablet of this product, put it in a 100ml measuring flask, add 50ml of 0.1mol/L hydrochloric acid solution, shake to disintegrate, the shaking was continued for 30 minutes to dissolve granisetron hydrochloride. Dilute the lmol/L hydrochloric acid solution to the scale, shake well, filter, and take the filtrate to light
  • .
  • UV-Vis spectrophotometry (General rule 0401), the absorbance was measured at the wavelength of 302nm; Another granisetron hydrochloride reference, precision weighing, add 0.lmol/L hydrochloric acid solution was dissolved and diluted quantitatively to prepare a solution containing about 10ug per lml, which was determined by the same method. Calculation of the content, should be in accordance with the provisions (General 0941).
  • 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 take appropriate amount (about equivalent to 8mg of granisetron), add the mobile phase to dissolve and quantitatively dilute to make a solution containing about 80ug granisetron per 1 ml, filter, and take the continued filtrate as the test solution, the results were obtained by multiplying the results by 0.8955 as determined under the granisetron hydrochloride assay.


category

Same as granisetron hydrochloride.


specification

lmg (based on C18H24N40)


storage

light shielding, sealed storage.

Last Update:2022-01-01 15:33:10

107007-99-8 - Granisetron Hydrochloride Injection

Authoritative Data Verified Data

This product is a sterile aqueous solution of granisetron hydrochloride. The content of granisetron hydrochloride shall be between 95.0% and 105.0% of the labeled amount calculated as granisetron (C18H24N40).


trait

This product is colorless or almost colorless clear liquid.


identification

  1. 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.
  2. take this product and use 0.1 mol/L hydrochloric acid solution is diluted to prepare a solution containing about 10ug of granisetron per 1 ml, which has a maximum absorption at a wavelength of 302nm as determined by UV-Vis spectrophotometry (General 0401), there is minimal absorption at a wavelength of 251nm.
  3. This product chloride identification (1) of the reaction (General 0301).

examination

  • the pH value should be 4.5 to 7.0 (General 0631).
  • Related substances this product was diluted with mobile phase to prepare a solution containing about 0.5mg of granisetron per 1 ml as a test solution. According to the method of granisetron hydrochloride 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 0.5 times (0.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
  • The endotoxin in the fine seedling is taken and checked according to law (General rule 1143). The amount of endotoxin in granisetron per 1 mg should be less than 20EU.
  • others should comply with the relevant provisions under injection (General 0102).

Content determination

take an appropriate amount of this product and quantitatively dilute it with mobile phase to prepare a solution containing about 80ug of granisetron per 1 ml as a test solution, the results were obtained by multiplying the results by 0.8955 as determined under the granisetron hydrochloride assay.


category

Same as granisetron hydrochloride.


specification

Based on C18H24N40 (l)lml:lmg (2)3ml:3Mg


storage

light shielding, closed storage.

Last Update:2022-01-01 15:33:11
107007-99-8
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MedChemExpress (MCE)
Multiple SpecificationsSpot supply
Product Name: BRL 43694A Visit Supplier Webpage Request for quotation
CAS: 107007-99-8
Tel: 609-228-6898
Email: sales@medchemexpress.com
     tech@medchemexpress.com
Mobile: 609-228-6898
SKYRUN INDUSTRIAL CO.,LTD
Spot supply
Product Name: Granisetron hydrochloride Visit Supplier Webpage Request for quotation
CAS: 107007-99-8
Tel: +86 0571-86722205
Email: sales@chinaskyrun.com
Mobile: +8618958170122
QQ: 2531159185 Click to send a QQ messageSend QQ message
Wechat: chinaskyrun
SHANGHAI ACMEC BIOCHEMICAL TECHNOLOGY CO., LTD.
Spot supply
Product Name: Granisetron hydrochloride Visit Supplier Webpage Request for quotation
CAS: 107007-99-8
Tel: +86-400-900-4166
Email: product@acmec-e.com
Mobile: +86-18621343501
QQ: 2881950922 Click to send a QQ message
Wechat: 18621343501
WhatsApp: +86-18621343501
Shanghai Macklin Biochemical Co., Ltd
Spot supply
Product Name: Granisetron hydrochloride Visit Supplier Webpage Request for quotation
CAS: 107007-99-8
Tel: +86-18821248368
Email: Int06@meryer.com
Mobile: +86-18821248368
QQ: 495145328 Click to send a QQ message
WhatsApp: +86-18821248368
Shanghai Yuanye Bio-Technology Co., Ltd.
Multiple SpecificationsSpot supply
Product Name: Granisetron hydrochloride Visit Supplier Webpage Request for quotation
CAS: 107007-99-8
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409 Click to send a QQ message
View History
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