GMP Certificate Cefpirome Sulfate, Cefoperazone Sodium & Sulbactam Sodium, Cefoperazone Sodium

Product Details
Customization: Available
Function: Antibiotic and Antimicrobial Agents
Certification: GMP
Gold Member Since 2005

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Management System Certification
ISO 9001, ISO 14000, ISO 20000, GMP, HACCP
Terms of Payment
LC, T/T, Western Union
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Basic Info.

Model NO.
CPS
Grade Standard
Medicine Grade
Type
Chemical Reagent
State
Solid
Volatile
Not Volatile
Odor
Odorless
Color
Colorless
Transport Package
Drums
Specification
GMP
Trademark
Fraken
Origin
China
HS Code
2941905600
Production Capacity
1000mt Per Year

Product Description

Cefoperazone Sodium

Contents of Testing

Requirements

Results of Analysis

Description

White crystalline Powder

Meets the requirements

Identification

Meets the requirements

Meets the requirements

pH

4.5~6.5

5.0

Water

≤5.0%

3.2%

Crystallinity

Meets the requirements

Meets the requirements

Bacterial endotoxin

≤0.20 EC/mg

Meets the requirements

Sterility

Meets the requirements

Meets the requirements

Particulate matter

Meets the requirements

≥10um

NMT 6000/G

≥25um

NMT 600/G

Assay

870~1015ug/mg

937 ug/mg


Cefoperazone Sodium & Sulbactam sodium 1:1, 2:1 
Product nameCefoperazone Sodium & Sulbactam Sodium 1:1
ItemsSpecificationResults
Appearancewhite or almost white powdercomplies
Identification1) HPLC: The retention time of the two major peaks in the chromatogram of the Assay preparation corresponds to those in the chromatogram of the standard preparation, as obtained in the Assaycomplies
2) Sodium reactioncomplies
Ph3.5-6.55.2
Clarity and color of solutionclarity ≤1#<0.5#
color ≤Y4# or YG4#<YG2#
Related substancesCefoperazone Impurity A  ≤1.5%0.3%
Any other impurity   ≤1.5%1.2%
Total impurities      ≤5%2.6%
Water≤4.0%2.1%
Bacterial endotoxins<0.05EU/mg<0.05EU/mg
Sterilitymeets the requirementcomplies
Visible particles≤5/4.0gcomplies
Particulate matter≥10μm particles: ≤6000/4.0g335
≥25μm particles: ≤600/4.0g10
Assay(anhydrous basis)Cefoperazone (C25H27N9O8S2)  ≥435μg/mg449μg/mg
Sulbactam (C8H11NO5S)  ≥445μg/mg464μg/mg
Residual solventsmeets the requirementscomplies
 
Cefoperazone Acid
ITEMSSPECIFICATIONRESULTS
Appearance           White to pale yellow Crystalline PowderPassed
IdentificationIR Spectrum
HPLC RT
Sodium
Passed
Passed
Passed
Clarity  ClearPassed
Color of SolutionNMT 0.2(430mm,10% solution)Passed
Specific optical rotation+56°~+64°+61°
PH4.5~6.55.5
Loss on drying≤3.0%2.7%
Chromatographic purity
Individual impurity
Total impurity
 
≤1.0%
≤3.0%
 
≤0.6%
≤2.0%
SterilitySterilePassed
Bacterial EndotoxinsNMT 0.20 USP EU/mgPassed
Particulate matter≥10um NMT 6000
≥25 um NMT 600
Passed
Passed
Assay(HPLC)916-964μg/mg940μg/mg


Cefpirome Sulfate
Cefpirome sulfate (CAS:98753-19-6 ) is a fourth-generation cephalosporin. Trade names include Cefrom, Keiten, Broact, Cefir. Cefpirome is considered highly active against Gram-negative bacteria, including Pseudomonas aeruginosa, and Gram-positive bacteria.
Product Name   Cefpirome sulfate
Quality Standard  JP15 / USP30
Specification  pure powder / containing carbonate sodium mixed powder
Appearance  white crystalline powder
PH  1.0-2.6
Assay  820ug / mg
Moisture  ≤0.5%
Residue on ignition  ≤0.5%
Uses  pharmaceutical raw materials, cephalosporin antibiotic fungi


Product namePackingStandard
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Cefotaxime Sodium5/6kg/Alu TinUSP
Ceftriaxone Sodium5/6kg/Alu TinUSP
Ceftriaxone Sodium & Sulbactam Sodium4/5kg/Alu TinUSP
Piperacillin Sodium4/4.5kg/Alu TinCP
Piperacillin Sodium & Tazobactam sodium4/5kg/Alu TinUSP
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Kitasamycin Tartrate2/3kg/Alu TinCP
Cefpirome Sulfate4/5kg/Alu TinUSP
Cefoperazone Sodium4/5kg/Alu TinUSP
Cefoperazone Sodium & Sulbactam sodium4/5kg/Alu TinCP
Sulbactam sodium4/5kg/Alu TinUSP
Trimetazidine Dihydrochloride4/5kg/Alu TinCP
Meclofenoxate Hydrochloride4/5kg/Alu TinCP
Neutral Proteinase1/2kg/Alu TinCP
Imatinib Mesylate4/5kg/Alu Tin 
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Service we can provide:
1. Mixed container, we can mix different items in one container.
2. Quality control, before shipment, free sample for test. After shipment, keep sample for 3 years
3. Prompt shipment with professional documents
4. Packing as your request, with photo before shipment.

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To get more information, just feel free to contact with us. Thanks.
Mr. Liu
Qingdao fraken international trading Co., Ltd
Address: RM1005 post mansion yan'an three road, qingdao, China
Tel: 0086 532 83899718
Fax: 0086 532 83623236
Web: http://fraken.en.made-in-china.com

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