ChemBK
  • Home
  • Product Category

Meropenem,anhydrous

Meropenem

CAS: 96036-03-2

Molecular Formula: C17H25N3O5S

  1. Home
  2. Product Category
  3. other
  4. other
  5. Meropenem,anhydrous

Meropenem,anhydrous - Names and Identifiers

Name Meropenem
Synonyms MEROPENAM
Meropenem
ici194660
antibioticsm7338
Meropenem,anhydrous
Meropenem anhydrous
5-beta,6-beta(r*)))-ph
Meropenemum [INN-Latin]
MEROPENEM, USP STANDARD
(4r,5s,6s)-3-[[(3s,5s)-5-dimethylcarbamoylpyrrolidin-3-
)-3-pyrrolidinyl)thio)-6-(1-hydroxyethyl)-4-methyl-7-oxo-,(4r-(3(s*,5s*),4-al
3-{[5-(dimethylcarbamoyl)pyrrolidin-3-yl]sulfanyl}-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid
(4r,5s,6s)-3-[[(3s,5s)-5-(dimethylcarbamoyl)pyrrolidin-3-yl]thio]-6-[(1r)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid
(4R,5S,6S)-3-{[(3S,5S)-5-(dimethylcarbamoyl)pyrrolidin-3-yl]sulfanyl}-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid
(4R,5S,6S)-3-[[(3S,5S)-5-[(Dimeth-ylamino)carbonyl]-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid
CAS 96036-03-2
EINECS 641-424-1
InChI InChI=1/C17H25N3O5S/c1-7-12-11(8(2)21)16(23)20(12)13(17(24)25)14(7)26-9-5-10(18-6-9)15(22)19(3)4/h7-12,18,21H,5-6H2,1-4H3,(H,24,25)

Meropenem,anhydrous - Physico-chemical Properties

Molecular FormulaC17H25N3O5S
Molar Mass383.46
Density1.42±0.1 g/cm3(Predicted)
Boling Point627.4±55.0 °C(Predicted)
Flash Point333.2°C
Solubility DMSO
Vapor Presure2.27E-18mmHg at 25°C
AppearanceWhite to light yellow crystalline powder
pKa4.27±0.60(Predicted)
Storage ConditionSealed in dry,Store in freezer, under -20°C
Refractive Index1.639
UseFor anti-infective drugs

Meropenem,anhydrous - Risk and Safety

Hazard SymbolsXi - Irritant
Irritant
Risk Codes36/37/38 - Irritating to eyes, respiratory system and skin.
Safety DescriptionS26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
S37/39 - Wear suitable gloves and eye/face protection
HS Code29419000

Meropenem,anhydrous - Reference

Reference
Show more
1. [IF=3.681] Rao Zhi et al."Determination of Total and Unbound Meropenem, Imipenem/Cilastatin, and Cefoperazone/Sulbactam in Human Plasma: Application for Therapeutic Drug Monitoring in Critically Ill Patients."Ther Drug Monit. 2020 Aug;42(4):578-587
2. [IF=6.514] Yan Guo et al."Metallo-β-lactamases inhibitor fisetin attenuates meropenem resistance in NDM-1-producing Escherichia coli."Eur J Med Chem. 2022 Jan;:114108

Meropenem,anhydrous - Standard

Authoritative Data Verified Data

This product is (1)-(4R,5S,6S)-3-[(3S,5S)-5-(dimethylamine)-3-pyrrolidine] thio -6 -[(lR)-l-Hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo [3. 2.0] hept-2-ene-2-carboxylic acid trihydrate. Meropenem (C17H25N305S) shall not be less than 98.0% calculated as anhydrous.

Last Update：2024-01-02 23:10:35

Meropenem,anhydrous - Trait

Authoritative Data Verified Data
  • This product is white to yellowish crystalline powder; Odorless.
  • This product is dissolved in methanol, slightly soluble in water, insoluble in acetone, ethanol or ether; In 0.1 mol/L sodium hydroxide solution dissolved in 0. Slightly soluble in lmol/L hydrochloric acid solution.

specific rotation

take an appropriate amount of this product, accurately weigh it, add water to dissolve and quantitatively dilute it to make a solution containing about 10 mg per lml, and determine it according to law (General rule 0621), the specific rotation should be from one to 17 ° to one to 21 °.

Last Update：2022-01-01 14:19:01

Meropenem,anhydrous - 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. The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 997).
Last Update：2022-01-01 14:19:01

Meropenem,anhydrous - Exam

Authoritative Data Verified Data

crystallinity

take this product, according to the law inspection (General 0981), should comply with the provisions.

acidity

take this product, add water to make a solution containing 10 mg per lml, according to the law (General 0631), the pH value should be 4.0~6.0.

clarity and color of solution

take 5 parts of this product, respectively, plus a clear 2% sodium carbonate solution made per 1 ml containing 0.lg solution, the solution should be clear and colorless; If it is turbid, it should not be more concentrated than the 1# turbidity standard solution (General 0902 first method); If it is colored, no deeper than the yellow or yellow-green standard colorimetric solution No. 5 (general rule 0901 method 1).

Related substances

take this product, add 0.1% triethylamine solution [take triethylamine 1.oml, add water 900ml, adjust the pH value to 5.0±0.1 with phosphoric acid solution (1-10), add water to dilute to 1000ml] dissolve and dilute to make a solution containing 5mg per lml as a test solution; Take appropriate amount with precision, the solution contained in 1 ml was prepared by quantitative dilution with 0.1% triethylamine solution as a control solution. According to the chromatographic conditions under the item of content determination, each lol of the test solution and the control solution is accurately weighed and injected into the human liquid chromatograph respectively, and the chromatogram is 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 the maximum impurity peak before the main peak and the area of the maximum impurity peak after the main peak shall not be greater than 0.6 times (0.3%) of the area of the main peak of the control solution, other single impurity peak area shall not be greater than 0.2 times (0.1%) of the main peak area of the control solution, and the sum of each impurity peak area shall not be greater than 2 times (1.0%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which were 0.1 times smaller than the main peak area of the control solution were ignored.

residual solvent

take about 0.4g of this product, precision weighing, put it in a 10ml measuring flask, Precision Add internal standard solution (take appropriate amount of ethanol, precision weighing, add water to make a solution containing about 1 mg per 1 ml) 2ml, dissolve with 1% sodium carbonate solution and dilute to the mark, shake. Take 5ml in a top empty bottle and seal it as a sample solution. Take appropriate amount of acetone, acetonitrile, dichloromethane, ethyl acetate and tetrahydrofuran, the mixture solution containing about 1.0 mg, 0.5mg, 0.3mg, 0.5mg and 0.3mg per 1 ml was quantitatively diluted by adding water. Take 5ml accurately, put it in a 50ml measuring flask, add 10ml of internal standard solution precisely, dilute it with water to scale, and shake well to obtain about ethanol, acetone, acetonitrile, dichloromethane, ethyl acetate and tetrahydrofuran were mixed solutions of 0.2mg, 0.1 mg, 0.05mg, 0.03mg, 0.05mg, and mg. 5ml was precisely weighed, placed in a top empty bottle, sealed, and as a reference solution, measured according to the residual solvent measurement method (General rule 0861, Method 1). The capillary column with 6% cyanopropylphenyl-94% dimethylpolysiloxane (or similar polarity) as stationary liquid was used as the chromatographic column; The column temperature was 50°C; The inlet temperature was 140°C, the temperature of the detector was 250°C; The equilibrium temperature of the headspace bottle was 90°C, and the equilibrium time was 30 minutes. The reference solution was sampled by Headspace injection, and the chromatogram was recorded, acetonitrile, methane, ethyl acetate, Tetrahydrofuran, the separation degree of each chromatographic peak shall meet the requirements. The test solution and the reference solution were injected into the headspace, the chromatogram was recorded, and the peak area ratio was calculated according to the internal standard method. Nitrile, dichloromethane, ethyl acetate and tetrahydrofuran residues shall be in accordance with the provisions.

moisture

take this product, according to the moisture determination method (General 0832 first method 1), the moisture content should be 11.4% ~ 13.4%.

ignition residue

take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.2%.

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).

visible foreign body

take 5 parts of this product, each 0.5g, add 2% sodium carbonate solution (filtered by 0.45um filter) to dissolve, check according to law (General rule 0904), should comply with the provisions. (For aseptic dispensing)

insoluble particles

Take 3 parts of this product, add 2% sodium carbonate solution (filtered through 0.45um filter) to make a solution containing 50mg per lml, and check according to law (General rule 0903), no more than 6000 particles containing 10um and more than lOum, and no more than 600 particles containing 25um and more than 25um. (For aseptic dispensing)

bacterial endotoxin

take an appropriate amount of this product and check it according to law (General rule 1143). The amount of endotoxin in meropenem per 1 mg (based on C17H25N3O5S) should be less than 0.12EU. (For injection)

sterile

take this product, add 2% sterile sodium carbonate solution (per lg meropenem, according to C17H25N3O5S, add 12.5) fully dissolved, add 0.1% sterile peptone aqueous solution to dilute it into a solution containing 20mg per 1 ml, filter the solution by membrane filtration, and rinse with 0.1% sterile peptone aqueous solution in portions (not less than 500ml per membrane), add not less than 3 million units of penicillinase to each tube of culture medium, with Staphylococcus aureus as positive control bacteria, according to law inspection (General 1101), should comply with the provisions. (For aseptic dispensing)

Last Update：2022-01-01 14:19:02

Meropenem,anhydrous - 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 was used as a filler; 0.1% triethylamine solution under related substances-acetonitrile (93.5:6.5) was used as a mobile phase; The detection wavelength was 220nm. Take appropriate amount of meropenem reference solution, heat in water bath for 1 hour, inject l0ul into human liquid chromatograph, record chromatogram, meropenem peak retention time is about 7 minutes, the peak order is meropenem ring opening, the resolution between meropenem, meropenem peak and meropenem ring-opening peak should meet the requirements.

assay

take an appropriate amount of this product and weigh it accurately. Add the above 0.1% triethylamine solution to dissolve and quantitatively dilute it to make a solution containing about mg per 1 ml as a test solution, 10u1 was injected into the liquid chromatograph for accurate measurement, and the chromatogram was recorded. According to the external standard method to calculate the peak area, that is.

Last Update：2022-01-01 14:19:03

Meropenem,anhydrous - Category

Authoritative Data Verified Data

beta-lactam antibiotics.

Last Update：2022-01-01 14:19:03

Meropenem,anhydrous - Storage

Authoritative Data Verified Data

sealed and stored in a cool dark dry place.

Last Update：2022-01-01 14:19:04

Meropenem,anhydrous - Meropenem for injection

Authoritative Data Verified Data

This product is meropenem plus anhydrous sodium carbonate made of sterile powder. The content of meropenem (calculated as C17H25N305S) shall be between 90.0% and 110.0% of the labeled amount, calculated as average.

trait

This product is white to yellowish powder.

identification

  1. take 1 bottle of this product, add 5ml of water to shake to dissolve, and then use 75% ethanol to make a solution containing about 10mg of meropenem (based on C17H25N305S) per 1 ml as the test solution: meropenem was dissolved by adding a small amount of pH 7.0 phosphate buffer solution, and then 75% ethanol to make a solution containing about 10mg per 1 ml as a reference solution; take appropriate amounts of meropenem control and cefazolin control, put them in the same container, and add a small amount of pH 7.0 phosphate buffer to dissolve, then a solution containing about 10mg each per 1 ml of 75% ethanol was prepared as a system-suitable solution. According to the thin layer chromatography (General 0502) test, take the above three solutions each 2 u1, respectively point on the same silica gel GF254 thin layer plate, with ethyl acetate-acetone-glacial acetic acid-water (5:2:2:1) for the development of the solvent, expand, dry, first set the UV lamp 254mn under the inspection, then set the iodine vapor in the color display, immediately view. The system applicable solution should show two clearly separated spots, and the position and color of the main spot displayed by the test solution should be the same as the position and color of the main spot of the reference solution.
  2. 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.
  3. take an appropriate amount of this product, add dilute acid, that is, bubble boiling, carbon dioxide, lead to calcium hydroxide solution, that is, white precipitation.
  4. two items (1) and (2) above can be selected as one item.

examination

  • alkalinity: take this product, add water to make a solution containing 5mg of meropenem (based on C17H25N305S) per lml, and determine it according to law (General rule 0631). The pH value should be 7.0~8.5.
  • the clarity and color of the solution take 5 bottles of this product, and add water according to the labeled amount to make each lml containing 0.lg solution, the solution should be clear and colorless, if it is turbid, compared with No. 1 turbidity standard solution (General 0902 first method), are not more concentrated; If the color, no deeper color shall be compared with the yellow or yellow-green standard colorimetric solution No. 6 (General rule 0901, Method 1).
  • relevant substances take appropriate amount of this product, add 0.1% triethylamine solution [take triethylamine l.Oml, add water 900ml, adjust pH to 5.0±0.1 with phosphoric acid solution (1-10), add water to dilute to 1000ml] dissolve and dilute to make meropenem per lml (based on C17H25N3O5S) 5mg solution, as the test solution, according to the method of meropenem, the peak area of a single impurity shall not be greater than the main peak area of the control solution (0.5% ) , the Peak area of each impurity shall not be greater than 3 times (1.5%) of the main peak area of the control solution.
  • weight loss on drying this product shall be dried under reduced pressure at 60°C to constant weight, and the weight loss shall be 9.0% ~ 12.0% (General rule 0831).
    • The content uniformity of
  • shall be calculated based on the content of each bottle measured under the content determination item, and shall comply with the regulations (General rule 0941).
  • insoluble particles this product is taken, and the labeled amount is added to the particle inspection water to make a solution containing 50mg per 1 ml, which is inspected according to law (General rule 0903), and the labeled amount is 1. The conversion below Og is that the particles containing 10um and l0um or more in each lg sample shall not exceed 6000 particles, and the particles containing 25um and 25um or more shall not exceed 600 particles. Label amount is l.Og or more (including l.Og) in each sample container containing 10um and more than 10um particles shall not exceed 6000, containing 25um and more than 25um particles shall not exceed 600.
  • bacterial endotoxin should be checked according to the method under meropenem, and it should be in accordance with the regulations.
  • sterile take this product, add 0.1% sterile peptone aqueous solution to dissolve and dilute to make a solution containing 20mg per 1 ml, and check according to the method of meropenem.
  • others should comply with the relevant provisions under injection (General 0102).

Content determination

Take 10 bottles of this product, add the above 0.1% triethylamine solution to dissolve and quantitatively dilute to prepare a solution containing mg of meropenem (based on C17H25N305S) per 1 ml as a test solution, the measurement was carried out according to the method of meropenem, and the average content of 10 vials was determined.

category

Same as meropenem.

specification

Based on C17H25N305S (1)0.25g (2)0.5g

storage

sealed and stored in a cool, dark and dry place.

Last Update：2022-01-01 14:19:05
Meropenem,anhydrous
Supplier List
Shanghai Yuanye Bio-Technology Co., Ltd.
Featured ProductsMultiple SpecificationsSpot supply
Product Name: Meropenem Visit Supplier Webpage Request for quotation
CAS: 96036-03-2
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409 Click to send a QQ message
Wechat: 18301782025
Nantong Reform Petro-Chemical CO., LTD.
Spot supply
Product Name: Meropenem Request for quotation
CAS: 96036-03-2
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: Meropenem Request for quotation
CAS: 96036-03-2
Tel: 17505222756
Email: pules.cn@gmail.com
Mobile: +86-17551318830
Wechat: 17505222756
Hubei YoungXin Pharmaceutical Tech Co.,Ltd.
Spot supply
Product Name: Meropenem Visit Supplier Webpage Request for quotation
CAS: 96036-03-2
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052 Click to send a QQ message
Wechat: 15671228036
Hefei TNJ Chemical Industry Co.,Ltd.
Product Name: Meropenem Request for quotation
CAS: 96036-03-2
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.
Featured ProductsMultiple SpecificationsSpot supply
Product Name: Meropenem Visit Supplier Webpage Request for quotation
CAS: 96036-03-2
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409 Click to send a QQ message
Wechat: 18301782025
Nantong Reform Petro-Chemical CO., LTD.
Spot supply
Product Name: Meropenem Request for quotation
CAS: 96036-03-2
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: Meropenem Request for quotation
CAS: 96036-03-2
Tel: 17505222756
Email: pules.cn@gmail.com
Mobile: +86-17551318830
Wechat: 17505222756
Hubei YoungXin Pharmaceutical Tech Co.,Ltd.
Spot supply
Product Name: Meropenem Visit Supplier Webpage Request for quotation
CAS: 96036-03-2
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052 Click to send a QQ message
Wechat: 15671228036
Hefei TNJ Chemical Industry Co.,Ltd.
Product Name: Meropenem Request for quotation
CAS: 96036-03-2
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
View History
Meropenem,anhydrous
  • Home
  • Product Category

© 2015, 2023 ChemBK.com All Rights Reserved | Build: 20230617001