High Quality USP Ferric Carboxymaltose, Iron Saccharate & Iron Sucrose

• Function: Blood System Agents
• Certification: GMP
• Grade Standard: Medicine Grade
• Type: Chemical Reagent
• State: Solid
• Volatile: Not Volatile
• Model NO.: IS
• Odor: Odorless
• Taste: Characteristic
• Color: as Per Your Request
• DMF: Available
• Transport Package: 25kgs/Drum
• Specification: USP
• Trademark: Fraken
• Origin: China
• HS Code: 2940000000
• Production Capacity: 100mt Per Year

Product Description

Iron sucrose is a complex of ferric hydroxide, Fe(OH)3, in sucrose, used intravenously to treat iron deficiency anemia in hemodialysis patients receiving supplemental therapy.

Iron sucrose is an intravenously administered iron product indicated in the treatment of iron deficiency anemia. It is frequently used in patients undergoing hemodialysis, those undergoing therapy, and/or patients who have chronic kidney disease. It is a type 2 complex which limits the maximum dose that can be given to 200mg which requires several administrations.

Iron sucrose is a form of the mineral iron. Iron is important for many functions in the body, especially for the transport of oxygen in the blood. Iron sucrose is used to treat iron deficiency anemia in people with kidney disease. It is usually given with another medication to promote the growth of red blood cells (such as Aranesp, Epogen, or Procrit). It is not for treating other forms of anemia not caused by iron deficiency.

Iron sucrose is a dark brown to reddish brown homogenous powder, almost odorless, sweet in taste and hygroscopic. Iron Sucrose Complex is a form of the mineral iron. Iron is important for many functions in the body, especially for the transport of oxygen in the blood. Iron sucrose injection is used to treat iron deficiency anemia in people with kidney disease. It is usually given with another medication to promote the growth of red blood cells (such as Aranesp, Epogen, or Procrit). This medication is not for treating other forms of anemia not caused by iron deficiency.
 

Name	Iron sucrose
Synonyms	Saccharated iron oxide; Ferric hydroxide sucrose complex
Molecular Formula	[Na2Fe5O8(H2O)]n.m(C12H22O11)
CAS Registry Number	8047-67-4
EINECS  Number	232-464-7

Powder:

Properties
Appearance	brown to dark brown powder
Assay	Sucrose≥80.0% Fe 5.3%~6.0%
PH	10.5~11.1
Free Iron	0.4% max
Free Cl	0.06% max
Turbidity (pH)	4.4-5.3
Specific gravity	1.135 -1.165
Osmolarity	1150-1350mOsmol/L
Alkalinity	0.5-0.8ml/ml
Mw	34000-60000 Da
Mn	>24000 Da
Mw/Mn	<1.7
Loss on dry	<0.5%
Heavy Metal	<25 ppm
Arsenic	<4ppm
Transport and Package
Transport	Can ship as normal chemical
Package	25kg/Paper drum

Liquid/Solution

TEST ITEM	SPECIFICATION
Appearance	Brown - dark  solution
Identification A (Iron)	Conform to USP Iron test
Identification B (Sucrose)	The retention time of the major peak in HPLC of the assay determination corresponds to that in the chromatogram of the standard determination under assay for sucrose
Mw	34000~60000 Da
Mn	NLT  24,000 Da
Mw/Mn	NMT 1.7
PH(2.0% w/v Fe)	9.0-11.1 at  20 ºC
Turbidity (pH)	4.4~5.3
Limit of Iron(II)	NMT 0.4%
Specefic gravity	1.135~1.165(20ºC)
Osmolarity	1150~1350mOsmol/L
Content of Chloride	NMT0.025%~0.055%
The Ratio of Chloride and Iron	7.0~14.0mg Cl/g Fe
Assay-Sucrose	45 %~65 %
Assay-Iron	3.5%~4.0%
The Ratio of Sucrose and Iron	13.0~17.0
Baterial endotoxin	NMT 3EU/mg Fe
Total bacterial	NMT 100CFU/g
Total mold/yeast	NMT 10CFU/g

Function
Iron sucrose is an intravenous drug approved for treatment of iron deficiency anemia in adult patients suffering from kidney disease and being treated with hemodialysis or peritoneal dialysis and/or the hormone erythropietin. Dialysis is a procedure that takes over for the kidneys, filtering blood and removing waste. Erythropietin helps stimulate the production of red blood cells.

Ferric Carboxymaltose
Ferric Carboxymaltose is an iron replacement product and chemically, an iron carbohydrate complex. Ferric carboxymaltose is a iron replacement product indicated for the treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron or those who have non-dialysis dependent chronic kidney disease. Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that release iron.
CAS NO.: 9007-72-1
Appearance: brown powder
Molecular structure:


Certificate of analysis

Item	Specification	Result
Appearance	brown powder	complies
Identification	Iron: positive	complies
	Dextrin: conforms	complies
Molecular weight	Mw 110,000~230,000Da	141,610
	Mn ≥60,000Da	87,132
	Mw/Mn  ≤1.9	1.6
PH	5.0~7.0	6.1
Limit of iron(II)	≤1.2%	0.2%
Chloride content	≤6.0%	4.2%
Residual solvents	Ethanol  ≤5000ppm	220ppm
Loss on drying	≤10.0%	5.8%
Copper	≤320ppm	complies
Assay of dextrin(on anhydrous basis)	25~50%	44.6%
Assay of iron(on anhydrous basis)	24~32%	28.2%

 

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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
Web: http://fraken.en.made-in-china.com/