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Gemcitabine HCl

Gemcitabine Hydrochloride

CAS: 122111-03-9

Molecular Formula: C9H12ClF2N3O4

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Gemcitabine HCl - Names and Identifiers

Name Gemcitabine Hydrochloride
Synonyms gemzar
ly188011
Gemcitabine HCl
ly188011hydrochloride
Gemcitabine hydrochlorid
Gemcitabine Hydrochloride
2',2'-DIFLUORO-2'-DEOXYCYTIDINE
2',2'-Difluoro-2'-deoxycytidine
2'-DEOXY-2',2'-DIFLUOROCYTIDINE
2,2-Difluoro-2-deoxycytidine DDFC
2',2'-difluorodeoxycytidinemonohydrochloride
2',2'-Difluoro-2'-deoxycytidine hydrochloride
2'-deoxy-2',2'-difluorocytidinemonohydrochloride
2'-deoxy-2',2'-difluoro-cytidinmonohydrochloride
4-amino-1-(2-deoxy-2,2-difluoropentofuranosyl)pyrimidin-2(1H)-one
4-Amino-1-[3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]-1H-pyrimidin-2-one hydrochloride
CAS 122111-03-9
EINECS 601-823-3
InChI InChI=1/C9H11F2N3O4.ClH/c10-9(11)6(16)4(3-15)18-7(9)14-2-1-5(12)13-8(14)17;/h1-2,4,6-7,15-16H,3H2,(H2,12,13,17);1H

Gemcitabine HCl - Physico-chemical Properties

Molecular FormulaC9H12ClF2N3O4
Molar Mass299.66
Melting Point>250°C dec.
Boling Point482.7°C at 760 mmHg
Specific Rotation(α)D +48°; 365 +257.9° (c = 1.0 in deuterated water)
Flash Point245.7°C
Solubility H2O: ≥10mg/mL
Vapor Presure2.41E-11mmHg at 25°C
AppearanceCrystalline powder
ColorWhite
Maximum wavelength(λmax)['268nm(H2O)(lit.)']
Merck14,4386
Storage Condition2-8°C
StabilityStable for 1 year from date of purchase as supplied. Solutions in DMSO or distilled water may be stored at -20° for up to 1 month.
MDLMFCD01735988
UseSuitable for the treatment of inoperable advanced or metastatic pancreatic cancer and the treatment of locally advanced or metastatic non-small cell lung cancer, the treatment of advanced non-small cell lung cancer, non-small cell lung cancer, pancreatic cancer, bladder cancer, breast cancer and other solid tumors.
In vitro studyGemcitabine acts on BxPC-3, PANC-1, and MIA PaCa-2 cells, induces NF-κB activity, acts on BxPC-3 and PANC-1 cells, and decreases NF-κB inhibitor IκBα levels. Low-dose Gemcitabine treatment of BxPC-3 cells for 48 hours increased NF-κB binding in a dose-dependent manner. In contrast, treatment of BxPC-3 cells with higher doses of Gemcitabine for 48 hours decreased NF-κB DNA binding, while treatment of BxPC-3 cells with higher doses of Gemcitabine for 24 hours increased NF-κB binding.
In vivo studyThe intratumoral NF-κB activity was significantly increased (1.3-to 1.8-fold) in Gemcitabine-treated mice compared to PBS-treated mice, indicating that Gemcitabine also induces NF-κB activity.

Gemcitabine HCl - Risk and Safety

Risk CodesR21 - 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 DescriptionS25 - Avoid contact with eyes.
S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
S36/37 - Wear suitable protective clothing and gloves.
S53 - Avoid exposure - obtain special instructions before use.
WGK Germany3
RTECSHA3840000
HS Code29420000

Gemcitabine HCl - Reference

Reference
Show more
1. Duan Tong, Li Jinsong. Effect of micro-RNA-615-3p down-regulation of pigment frame homologous protein 6 on lung cancer gemcitabine chemotherapy resistant cell lines and its mechanism [J]. Chinese Journal of Clinical Pharmacology, 2021,37(04):416-420.

Gemcitabine HCl - Standard

Authoritative Data Verified Data

This product is 2 '-Deoxy-2',2 '-difluorocytidine isomer) hydrochloride. The content of C9H11F2N3O4 • HCl should be between 98.0% and 102.0% based on the dry product.

Last Update：2024-01-02 23:10:35

Gemcitabine HCl - Trait

Authoritative Data Verified Data
  • This product is white or off-white crystalline powder.
  • This product is dissolved in water, slightly soluble in methanol, and almost insoluble in acetone.

specific rotation

take this product, precision weighing, adding water to dissolve and dilute the solution containing about 10 mg per 1 ml, according to the law (General 0621), the specific rotation is 43 ° to 50 °.

Last Update：2022-01-01 14:22:19

Gemcitabine HCl - 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 an appropriate amount of this product, add water to dissolve and dilute to prepare a solution containing about lOug per lml, and measure it by UV-Vis spectrophotometry (General rule 0401), there is an absorption maximum at a wavelength of 269nm.
  3. The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1014).
  4. the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 14:22:19

Gemcitabine HCl - Exam

Authoritative Data Verified Data

acidity

take 0.10g of this product, Add 10ml of water to dissolve it, and determine it according to law (General rule 0631). The pH value should be 2.0~3.0.

clarity and color of solution

take 0.10g of this product and add 0902 of water to dissolve the solution. The solution should be clear and colorless. If it is turbid, it should not be deeper compared with No. 1 turbidity standard solution (General rule first method).

Related substances

precision weigh the appropriate amount of this product, add water to dissolve and quantitatively dilute the solution containing about 2mg per 1 ml, as a test solution; an appropriate amount of gemcitabine hydrochloride control substance and cytosine (impurity I) was accurately weighed, dissolved with water and quantitatively diluted to prepare a solution containing about 2ug per 1 ml, which was used as a control solution. According to the determination of high performance liquid chromatography (General 0512), using octyl silane bonded silica gel as filler, 0.14mol/L phosphate buffer (take sodium dihydrogen phosphate 13.8g and phosphoric acid 2.5, add water to dissolve and dilute to 1000ml,pH value should be 2.5±0.1)-methanol (97:3) as mobile phase A, 0.14mol/L phosphate buffer-methanol (50:50) as mobile phase B; gradient elution was carried out according to the following table (if necessary, adjust the chromatographic system so that gemcitabine peaks within 8 minutes), and the detection wavelength was 275nm. The system applicable solution 20 u1 under the content determination item was injected into the liquid chromatograph, and the chromatogram was recorded. The order of peaks was cytosine peak, a-isomer (impurity II) peak and gemcitabine peak, the resolution between the-isomer peak and the gemcitabine peak should be greater than 8.0 and the tailing factor of the gemcitabine peak should not be greater than 1.5. 20 u1 of the test solution and the reference solution were respectively injected into the liquid chromatograph, and the chromatograms were recorded. If there are impurity peaks in the chromatogram of the test solution, cytosine shall not exceed 0.1% based on peak area calculated by external standard method, and the remaining impurities shall not exceed 0.1% based on gemcitabine peak area calculated by external standard method, other individual unknown impurities shall not exceed 0.1%, and the total amount of impurities shall not exceed 0.2%. Impurity peaks with a content of less than 0.02% are negligible.

loss on drying

take this product, dry to constant weight at 105°C, weight loss shall not exceed 1.0% (General rule 0831).

ignition residue

take l.Og of this product and check it according to law (General rule 0841 eight residues shall not exceed 0.1%.

Heavy metals

The residue left under the item of ignition residue shall not be more than 10 parts per million (ppm) and shall be inspected according to law (General rule 0821 second law).

Last Update：2022-01-01 14:22:20

Gemcitabine HCl - Content determination

Authoritative Data Verified Data

measured by high performance liquid chromatography (General 0512).

chromatographic conditions and system suitability test

A mobile phase of 0.14mol/L phosphate buffer (pH 2.5 )-methanol (97:3) was used with octanosilane-bonded silica gel as a filler, and the detection wavelength was 275nm. Take about 10 mg of gemcitabine hydrochloride control, put it in a 100ml measuring flask, add potassium hydroxide methanol solution (take potassium hydroxide 1.68g, add methanol 10ml, shake to dissolve) 4ml, Seal, ultrasonic to dissolve, heat at 55°C water bath for 6-16 hours, let cool, dilute to scale with 1% Phosphoric acid solution, shake well, as a system-suitable solution (about 0.02mg isomer per 1 ml). 20ul of the applicable solution of the system is taken, and human liquid chromatography is injected to record the chromatogram. The resolution between the isomer peak and gemcitabine peak should be greater than 8.0, and the tailing factor of gemcitabine peak should not be greater than 1.5.

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 was used as the test solution, and 20 u1 was accurately measured, and the human liquid chromatograph was injected, and the chromatogram was recorded. In addition, an appropriate amount of gemcitabine hydrochloride reference substance was taken, and the same method was used for determination. According to the external standard method to calculate the peak area, that is.

Last Update：2022-01-01 14:22:21

Gemcitabine HCl - Category

Authoritative Data Verified Data

antineoplastic agents.

Last Update：2022-01-01 14:22:21

Gemcitabine HCl - Storage

Authoritative Data Verified Data

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

Last Update：2022-01-01 14:22:21

Gemcitabine HCl - Gemcitabine hydrochloride for injection

Authoritative Data Verified Data

This product is a sterile freeze-dried product of gemcitabine hydrochloride, containing gemcitabine hydrochloride according to gemcitabine (C9H11F2N304), which should be 95.0% ~ 105.0% of the label amount.

trait

This product is white loose lumps or powder.

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 the contents of this product, add water to dissolve and dilute to prepare a solution containing 10ug of gemcitabine per lml, according to UV-Vis spectrophotometry (General 0401) 9 was measured to have an absorption maximum at a wavelength of 269nm.
  3. the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).

examination

  • acidity take this product, add 0.9% sodium chloride solution to dissolve and dilute to prepare a solution containing gemcitabine 40mg per lml, and determine it according to law (General rule 0631). The pH value should be 2.7~3.3.
  • clarity and color of solution take 5 bottles of this product, add 0.9% sodium chloride solution to dissolve and dilute to make a solution containing about 20mg of gemcitabine per lm l, and the solution should be clear and colorless.
  • Related Substances: take this product, dissolve it with water and quantitatively dilute it to prepare a solution containing about 2mg of gemcitabine per 1 ml, which is used as a test solution; Take an appropriate amount of gemcitabine hydrochloride reference and cytosine reference, water was added to dissolve and quantitatively diluted to prepare a mixed solution containing about 2UG each in 1 ml as a control solution. Determination according to the method of gemcitabine hydrochloride related substances. If there are impurity peaks in the chromatogram of the test solution, cytosine shall be calculated by the peak area according to the external standard method, and 0.1% of the labeled amount of gemcitabine shall not be exceeded. The remaining impurities shall be calculated by the peak area of gemcitabine according to the external standard method, and the results are multiplied by 0.8783, the-isomer shall not exceed 0.1% of the labeled amount of gemcitabine, other single impurities shall not exceed 0.2% of the labeled amount of gemcitabine, and the total amount of impurities shall not exceed 0.3% of the labeled amount of gemcitabine. Impurity peaks with a content of less than 0.02% of the labeled amount of gemcitabine are negligible.
  • the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 2.5%, first method 1).
  • bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per 1 mg of gemcitabine should be less than 0.050EU.
  • others should comply with the relevant provisions under injection (General 0102).

Content determination

Take 3 bottles of this product, add water to dissolve and quantitatively dilute the solution containing 0.1mg of gemcitabine in each lml, as the test solution, the assay was performed according to the method under the gemcitabine hydrochloride assay. According to the external standard method, the peak area is calculated, and the result is multiplied by 0.8783, and the average value of 3 bottles is calculated.

category

with gemcitabine hydrochloride.

specification

(1)0.2g (2) 1.0g

storage

sealed and stored in a dry place.

Last Update：2022-01-01 14:22:22
Gemcitabine HCl
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Wuhan Boye Science And Technology Development Co., Ltd.
Featured ProductsMultiple Specifications
Product Name: Gemcitabine hydrochloride Request for quotation
CAS: 122111-03-9
Tel: 86-10-10086 81625225
Email: yeqim@boyechemicals.com
Mobile: 86-15387090420
QQ: 1377812380 Click to send a QQ message
Wechat: 15387090420
Hubei YoungXin Pharmaceutical Tech Co.,Ltd.
Spot supply
Product Name: Gemcitabine Visit Supplier Webpage Request for quotation
CAS: 122111-03-9
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052 Click to send a QQ message
Wechat: 15671228036
Nantong Reform Petro-Chemical CO., LTD.
Spot supply
Product Name: Gemcitabine Hydrochloride Request for quotation
CAS: 122111-03-9
Tel: +86-17551318830
Email: r@reformchem.com­
Mobile: +86-17551318830
QQ: 3785839865 Click to send a QQ messageSend QQ message
Jiangsu Pules Biotechnology Co.,Ltd.
Product Name: Gemcitabine Hydrochloride Request for quotation
CAS: 122111-03-9
Tel: 17505222756
Email: pules.cn@gmail.com
Mobile: +86-17551318830
Wechat: 17505222756
Hefei TNJ Chemical Industry Co.,Ltd.
Product Name: Gemcitabine Hydrochloride Request for quotation
CAS: 122111-03-9
Tel: 0086-551-65418684
Email: sales@tnjchem.com
　　　　 info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840 Click to send a QQ message
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
Shanghai Yuanye Bio-Technology Co., Ltd.
Spot supply
Product Name: dFdCyd Visit Supplier Webpage Request for quotation
CAS: 122111-03-9
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409 Click to send a QQ message
Wechat: 18301782025
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Gemcitabine HCl
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