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

• Function: Antibiotic and Antimicrobial Agents
• Certification: GMP
• Grade Standard: Medicine Grade
• Type: Chemical Reagent
• State: Solid
• Volatile: Not Volatile
• Model NO.: CPS
• 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 name	Cefoperazone Sodium & Sulbactam Sodium 1:1
Items	Specification	Results
Appearance	white or almost white powder	complies
Identification	1) 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 Assay	complies
	2) Sodium reaction	complies
Ph	3.5-6.5	5.2
Clarity and color of solution	clarity ≤1#	<0.5#
	color ≤Y4# or YG4#	<YG2#
Related substances	Cefoperazone 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
Sterility	meets the requirement	complies
Visible particles	≤5/4.0g	complies
Particulate matter	≥10μm particles: ≤6000/4.0g	335
	≥25μm particles: ≤600/4.0g	10
Assay(anhydrous basis)	Cefoperazone (C25H27N9O8S2)  ≥435μg/mg	449μg/mg
	Sulbactam (C8H11NO5S)  ≥445μg/mg	464μg/mg
Residual solvents	meets the requirements	complies

 
Cefoperazone Acid

ITEMS	SPECIFICATION	RESULTS
Appearance	White to pale yellow Crystalline Powder	Passed
Identification	IR Spectrum HPLC RT Sodium	Passed Passed Passed
Clarity	Clear	Passed
Color of Solution	NMT 0.2(430mm,10% solution)	Passed
Specific optical rotation	+56°~+64°	+61°
PH	4.5~6.5	5.5
Loss on drying	≤3.0%	2.7%
Chromatographic purity Individual impurity Total impurity	≤1.0% ≤3.0%	≤0.6% ≤2.0%
Sterility	Sterile	Passed
Bacterial Endotoxins	NMT 0.20 USP EU/mg	Passed
Particulate matter	≥10um NMT 6000 ≥25 um NMT 600	Passed Passed
Assay(HPLC)	916-964μg/mg	940μg/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 name	Packing	Standard
Mezlocillin Sodium	4/5kg/Alu Tin	USP
Cefotaxime Sodium	5/6kg/Alu Tin	USP
Ceftriaxone Sodium	5/6kg/Alu Tin	USP
Ceftriaxone Sodium & Sulbactam Sodium	4/5kg/Alu Tin	USP
Piperacillin Sodium	4/4.5kg/Alu Tin	CP
Piperacillin Sodium & Tazobactam sodium	4/5kg/Alu Tin	USP
Ampicillin sodium & Sulbactam Sodium	4/5kg/Alu Tin	USP
Kitasamycin Tartrate	2/3kg/Alu Tin	CP
Cefpirome Sulfate	4/5kg/Alu Tin	USP
Cefoperazone Sodium	4/5kg/Alu Tin	USP
Cefoperazone Sodium & Sulbactam sodium	4/5kg/Alu Tin	CP
Sulbactam sodium	4/5kg/Alu Tin	USP
Trimetazidine Dihydrochloride	4/5kg/Alu Tin	CP
Meclofenoxate Hydrochloride	4/5kg/Alu Tin	CP
Neutral Proteinase	1/2kg/Alu Tin	CP
Imatinib Mesylate	4/5kg/Alu Tin
Erlotinib Hydrochloride	4/5kg/Alu Tin
Gefitinib	4/5kg/Alu Tin

 

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: [phone]
Fax: [phone]
Web: http://fraken.en.made-in-china.com