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1. Acetoxyethylcefuroxime
2. Cci 15641
3. Cci-15641
4. Ceftin
5. Cefurax
6. Cefuroxime 1-acetoxyethyl Ester
7. Cepazine
8. Cetoxil
9. Curocef
10. Elobact
11. Novador
12. Novocef
13. Oraxim
14. Zinat
15. Zinnat
1. 97232-96-7
2. Cefuroxime Axetil, (e)-
3. 64544-07-6
4. (+/-)-cefuroxime Axetil, (e)-
5. Xsl6i3sb26
6. Ceftin
7. Cefuroxime Axetil E-isomers
8. 1-acetyloxyethyl (6r,7r)-3-(carbamoyloxymethyl)-7-[[(2e)-2-(furan-2-yl)-2-methoxyiminoacetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
9. (1rs)-1-(acetyloxy)ethyl (6r,7r)-3-((carbamoyloxy)methyl)-7-(((e)-2-(furan-2-yl)-2-(methoxyimino)acetyl)amino)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2carboxylate
10. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 3-(((aminocarbonyl)oxy)methyl)-7-(((2e)-2-(2-furanyl)-2-(methoxyimino)acetyl)amino)-8-oxo-, 1-(acetyloxy)ethyl Ester, (6r,7r)-
11. Unii-xsl6i3sb26
12. Cefuroxime Axetil Impurity B [ep]
13. Cefuroximeaxetil
14. Cefuroxime Axetil Specified Impurity B [ep]
15. Schembl41099
16. Schembl379336
17. Dtxsid20242788
18. Mfcd00864991
19. Akos037643328
20. Ncgc00185751-06
21. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 3-(((aminocarbonyl)oxy)methyl)-7-((2-furanyl(methoxyimino)acetyl)amino)-8-oxo-, 1-(acetyloxy)ethyl Ester, (6r-(6alpha,7beta(e)))-
22. Cefuroxime Axetil E-isomers [usp-rs]
23. Cefuroxime Axetil Impurity B [ep Impurity]
24. Q3604308
25. 1-(acetyloxy)ethyl (6r,7r)-3-{[(aminocarbonyl)oxy]methyl}-7-({(2e)-2-furan-2-yl-2-[(methyloxy)imino]acetyl}amino)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
26. 1-acetoxyethyl (6r,7r)-3-carbamoyloxymethyl-7-[(z)-2-(fur-2-yl)-2-methoxyiminoacetamido]ceph-3-em-4-carboxylate
27. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 3-(((aminocarbonyl)oxy)methyl)-7-((2-furanyl(methoxyimino)acetyl)amino)-8-oxo-, 1-(acetyloxy)ethyl Ester, (6r-(6.alpha.,7.beta.(e)))-
28. 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 3-[[(aminocarbonyl)oxy]methyl]-7-[[(2z)-2-(2-furanyl)-2-(methoxyimino)acetyl]amino]-8-oxo-, 1- (acetyloxy)ethyl Ester, (6r,7r)-
| Molecular Weight | 510.5 g/mol |
|---|---|
| Molecular Formula | C20H22N4O10S |
| XLogP3 | 0.9 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 12 |
| Rotatable Bond Count | 12 |
| Exact Mass | 510.10566408 g/mol |
| Monoisotopic Mass | 510.10566408 g/mol |
| Topological Polar Surface Area | 214 Ų |
| Heavy Atom Count | 35 |
| Formal Charge | 0 |
| Complexity | 968 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 2 | |
|---|---|
| Drug Name | Cefuroxime axetil |
| Drug Label | Cefuroxime axetil tablets USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, broad-spectrum cephalosporin antibiotic for oral administration.Chemically, cefuroxime axetil, the 1-(acetyloxy) ethyl ester of cefuroxime, i... |
| Active Ingredient | Cefuroxime axetil |
| Dosage Form | Tablet; For suspension |
| Route | Oral |
| Strength | eq 250mg base/5ml; eq 500mg base; eq 125mg base; eq 250mg base; eq 125mg base/5ml |
| Market Status | Prescription |
| Company | Wockhardt; Ranbaxy; Teva; Apotex; Alkem Labs; Aurobindo Pharma; Lupin; Orchid Hlthcare |
| 2 of 2 | |
|---|---|
| Drug Name | Cefuroxime axetil |
| Drug Label | Cefuroxime axetil tablets USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, broad-spectrum cephalosporin antibiotic for oral administration.Chemically, cefuroxime axetil, the 1-(acetyloxy) ethyl ester of cefuroxime, i... |
| Active Ingredient | Cefuroxime axetil |
| Dosage Form | Tablet; For suspension |
| Route | Oral |
| Strength | eq 250mg base/5ml; eq 500mg base; eq 125mg base; eq 250mg base; eq 125mg base/5ml |
| Market Status | Prescription |
| Company | Wockhardt; Ranbaxy; Teva; Apotex; Alkem Labs; Aurobindo Pharma; Lupin; Orchid Hlthcare |
Anti-Bacterial Agent
National Library of Medicine's Medical Subject Headings. Cefuroxime axetil. Online file (MeSH, 2014). Available from, as of November 19, 2013: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html
Ceftin tablets and oral suspension /are indicated for/ acute bacterial otitis media caused by Streptococcus pneumoniae, Haemophilusinfluenzae(including beta-lactamase-producing strains), Moraxellacatarrhalis (including beta-lactamase-producing strains), or Streptococcus pyogenes. /Included in US product label/
US Natl Inst Health; DailyMed. Current Medication Information for ICEFTIN (cefuroxime axetil) powder, for suspension CEFTIN (cefuroxime axetil) tablet, film coated (July 2011). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f439b86-59d6-4350-aeb4-c904b3781db4
Ceftin tablets and oral suspension /are indicated for/ pharyngitis/tonsillitis caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Ceftin Tablets are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime in the subsequent prevention of rheumatic fever are not available. Please also note that in all clinical trials, all isolates had to be sensitive to both penicillin and cefuroxime. There are no data from adequate and well-controlled trials to demonstrate the effectiveness of cefuroxime in the treatment of penicillin-resistant strains of Streptococcus pyogenes. /Included in US product label/
US Natl Inst Health; DailyMed. Current Medication Information for ICEFTIN (cefuroxime axetil) powder, for suspension CEFTIN (cefuroxime axetil) tablet, film coated (July 2011). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f439b86-59d6-4350-aeb4-c904b3781db4
Ceftin tablets /are indicated for/ acute bacterial maxillary sinusitis caused by Streptococcus pneumoniaeorHaemophilusinfluenzae (non-beta-lactamase-producing strains only). NOTE: In view of the insufficient numbers of isolates of beta-lactamase-producing strains of Haemophilusinfluenzae and Moraxellacatarrhalis that were obtained from clinical trials with Ceftin Tablets for patients with acute bacterial maxillary sinusitis, it was not possible to adequately evaluate the effectiveness of Ceftin Tablets for sinus infections known, suspected, or considered potentially to be caused by beta-lactamase-producing Haemophilusinfluenzae or Moraxellacatarrhalis. /Included in US product label/
US Natl Inst Health; DailyMed. Current Medication Information for ICEFTIN (cefuroxime axetil) powder, for suspension CEFTIN (cefuroxime axetil) tablet, film coated (July 2011). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f439b86-59d6-4350-aeb4-c904b3781db4
For more Therapeutic Uses (Complete) data for Cefuroxime axetil (15 total), please visit the HSDB record page.
Patients should be advised that antibacterials (including cefuroxime) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold). Patients also should be advised about the importance of completing the full course of therapy, even if feeling better after a few days, and that skipping doses or not completing therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with cefuroxime or other antibacterials in the future.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 71
To reduce development of drug-resistant bacteria and maintain effectiveness of cefuroxime and other antibacterials, the drug should be used only for the treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria. When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 71
Prior to initiation of cefuroxime therapy, careful inquiry should be made concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. Cefuroxime axetil /is/ contraindicated in patients who are hypersensitive to cefuroxime or other cephalosporins and should be used with caution in patients with a history of hypersensitivity to penicillins. Use of cephalosporins should be avoided in patients who have had an immediate-type (anaphylactic) hypersensitivity reaction to penicillins.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 71
Prescribing Ceftin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
US Natl Inst Health; DailyMed. Current Medication Information for ICEFTIN (cefuroxime axetil) powder, for suspension CEFTIN (cefuroxime axetil) tablet, film coated (July 2011). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f439b86-59d6-4350-aeb4-c904b3781db4
For more Drug Warnings (Complete) data for Cefuroxime axetil (18 total), please visit the HSDB record page.
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
Following oral administration of cefuroxime axetil in pediatric patients with acute otitis media with effusion or with chronic or recurrent otitis media with effusion, cefuroxime is distributed into middle ear effusions. In a study in pediatric patients 1-4 years of age with acute otitis media with effusion who received a single 15 mg/kg dose of cefuroxime as cefuroxime axetil oral suspension, cefuroxime concentrations in middle ear effusions 2-5 hours after a dose ranged from 0.2-3.6 ug/mL; concurrent serum concentrations were 2.8-7.3 ug/mL.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 74
In pharmacokinetic studies of cefuroxime axetil oral suspension in children, the drug was administered postprandially or with food; no data are available regarding absorption of the suspension in fasting children. Following oral administration to children 3 months to 12 years of age (mean age: 23 months) of a single 10-, 15-, or 20-mg/kg dose of commercially available cefuroxime axetil oral suspension concomitantly with milk or milk products, peak serum cefuroxime concentrations are attained approximately 3.6, 2.7, or 3.1 hours after the dose, respectively, and average 3.3, 5.1, or 7 mcg/mL, respectively.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 73
Results of a study in healthy adults indicate that cefuroxime axetil oral suspensions containing 125 mg/5 mL or 250 mg/5 mL are bioequivalent. In healthy adults who received a 250-mg dose of cefuroxime axetil given as a suspension containing 125 mg/5 mL or 250 mg/5 mL with food, peak plasma concentrations of cefuroxime were 2.4 or 2.2 aug/mL, respectively, and were attained 3 hours after the dose.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 73
Following oral administration in adults of a single 125-mg, 250-mg, 500-mg, or 1-g dose of commercially available cefuroxime axetil tablets immediately following a meal, peak serum cefuroxime concentrations are attained approximately 2-3 hours after the dose and average 2.1, 4.1, 7, or 13.6 ug/mL, respectively; serum concentrations 6 hours after the dose average 0.3, 0.7, 2.2, or 3.4 ug/mL, respectively. AUC of the drug in these individuals averaged 6.7, 12.9, 27.4, or 50 mcg-h/mL, respectively.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 73
For more Absorption, Distribution and Excretion (Complete) data for Cefuroxime axetil (13 total), please visit the HSDB record page.
Following oral administration, cefuroxime axetil is rapidly hydrolyzed to cefuroxime by nonspecific esterases in the intestinal mucosa and blood; the axetil moiety is metabolized to acetaldehyde and acetic acid. Cefuroxime is not metabolized and is excreted unchanged principally in urine by both glomerular filtration and tubular secretion.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 74
In neonates and children, the serum half-life of cefuroxime is inversely proportional to age.6 25 30 Following oral administration of cefuroxime axetil oral suspension in children 3 months to 12 years of age, the serum half-life of cefuroxime averages 1.4-1.9 hours.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 74
In adults, the serum or plasma half-life of cefuroxime following oral administration of commercially available cefuroxime axetil tablets or oral suspension ranges from 1.2-1.6 hours.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 74
Because cefuroxime is renally excreted, the serum half-life is prolonged in patients with reduced renal function. In a study of 20 elderly patients (mean age = 83.9 years) having a mean creatinine clearance of 34.9 mL/min, the mean serum elimination half-life was 3.5 hours.
US Natl Inst Health; DailyMed. Current Medication Information for ICEFTIN (cefuroxime axetil) powder, for suspension CEFTIN (cefuroxime axetil) tablet, film coated (July 2011). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f439b86-59d6-4350-aeb4-c904b3781db4
Cefuroxime is usually bactericidal in action.Like other cephalosporins, the antibacterial activity of the drug results from inhibition of mucopeptide synthesis in the bacterial cell wall.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 72
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DMF Number : 21508
Submission : 2008-03-29
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GDUFA
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DMF Number : 21615
Submission : 2008-05-10
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Written Confirmation Number : WC-0008
Address of the Firm :
GDUFA
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Submission : 2008-05-27
Status : Active
Type : II
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DMF Number : 14653
Submission : 2000-01-03
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-398 - Rev 00
Issue Date : 2007-02-23
Type : Chemical
Substance Number : 1300
Status : Valid
GDUFA
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PharmaCompass also assists you with knowing the Cefuroxime Axetil API Price utilized in the formulation of products. Cefuroxime Axetil API Price is not always fixed or binding as the Cefuroxime Axetil Price is obtained through a variety of data sources. The Cefuroxime Axetil Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A acetoxyethylcefuroxime manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of acetoxyethylcefuroxime, including repackagers and relabelers. The FDA regulates acetoxyethylcefuroxime manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. acetoxyethylcefuroxime API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A acetoxyethylcefuroxime supplier is an individual or a company that provides acetoxyethylcefuroxime active pharmaceutical ingredient (API) or acetoxyethylcefuroxime finished formulations upon request. The acetoxyethylcefuroxime suppliers may include acetoxyethylcefuroxime API manufacturers, exporters, distributors and traders.
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A acetoxyethylcefuroxime DMF (Drug Master File) is a document detailing the whole manufacturing process of acetoxyethylcefuroxime active pharmaceutical ingredient (API) in detail. Different forms of acetoxyethylcefuroxime DMFs exist exist since differing nations have different regulations, such as acetoxyethylcefuroxime USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A acetoxyethylcefuroxime DMF submitted to regulatory agencies in the US is known as a USDMF. acetoxyethylcefuroxime USDMF includes data on acetoxyethylcefuroxime's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The acetoxyethylcefuroxime USDMF is kept confidential to protect the manufacturer’s intellectual property.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a acetoxyethylcefuroxime Drug Master File in Korea (acetoxyethylcefuroxime KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of acetoxyethylcefuroxime. The MFDS reviews the acetoxyethylcefuroxime KDMF as part of the drug registration process and uses the information provided in the acetoxyethylcefuroxime KDMF to evaluate the safety and efficacy of the drug.
After submitting a acetoxyethylcefuroxime KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their acetoxyethylcefuroxime API can apply through the Korea Drug Master File (KDMF).
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A acetoxyethylcefuroxime CEP of the European Pharmacopoeia monograph is often referred to as a acetoxyethylcefuroxime Certificate of Suitability (COS). The purpose of a acetoxyethylcefuroxime CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of acetoxyethylcefuroxime EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of acetoxyethylcefuroxime to their clients by showing that a acetoxyethylcefuroxime CEP has been issued for it. The manufacturer submits a acetoxyethylcefuroxime CEP (COS) as part of the market authorization procedure, and it takes on the role of a acetoxyethylcefuroxime CEP holder for the record. Additionally, the data presented in the acetoxyethylcefuroxime CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the acetoxyethylcefuroxime DMF.
A acetoxyethylcefuroxime CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. acetoxyethylcefuroxime CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A acetoxyethylcefuroxime written confirmation (acetoxyethylcefuroxime WC) is an official document issued by a regulatory agency to a acetoxyethylcefuroxime manufacturer, verifying that the manufacturing facility of a acetoxyethylcefuroxime active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting acetoxyethylcefuroxime APIs or acetoxyethylcefuroxime finished pharmaceutical products to another nation, regulatory agencies frequently require a acetoxyethylcefuroxime WC (written confirmation) as part of the regulatory process.
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National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing acetoxyethylcefuroxime as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for acetoxyethylcefuroxime API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture acetoxyethylcefuroxime as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain acetoxyethylcefuroxime and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a acetoxyethylcefuroxime NDC to their finished compounded human drug products, they may choose to do so.
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acetoxyethylcefuroxime Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of acetoxyethylcefuroxime GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right acetoxyethylcefuroxime GMP manufacturer or acetoxyethylcefuroxime GMP API supplier for your needs.
A acetoxyethylcefuroxime CoA (Certificate of Analysis) is a formal document that attests to acetoxyethylcefuroxime's compliance with acetoxyethylcefuroxime specifications and serves as a tool for batch-level quality control.
acetoxyethylcefuroxime CoA mostly includes findings from lab analyses of a specific batch. For each acetoxyethylcefuroxime CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
acetoxyethylcefuroxime may be tested according to a variety of international standards, such as European Pharmacopoeia (acetoxyethylcefuroxime EP), acetoxyethylcefuroxime JP (Japanese Pharmacopeia) and the US Pharmacopoeia (acetoxyethylcefuroxime USP).
