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cGMP, GLP - FDA Approved, ISO 9001, ISO 14001, ISO 17025, ISO 45001, HACCP, FSSC 22000, FSSAI, "REACH" Registered, Kosher & Halal Certified. We observe WHO Good Manufacturing Practice GMP and Good Laboratory Practice GLP.
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for Active Substance to be imported into European Union (EU).
Iron Sucrose and Ferric Saccharate or Iron D Saccharate or Sucroferric Oxyhydroxide USP BP Ph Eur Grade Manufacturers
Anmol Chemicals is a manufacturer supplier exporter of Iron Sucrose and Iron D Saccharate and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.
All technical documents and DMF support available.
Iron Sucrose & Iron D Saccharate or Sucroferric Oxyhydroxide SDS of Manufacturers
Synonyms: Ferric hydroxide sucrose complex, Iron oxide saccharated, Iron saccharate, Iron sucrose, Iron sucrose complex, Iron sugar, Iron(III) hydroxide sucrose complex, Saccharated ferric oxide, Saccharated iron, Saccharated iron oxide, Sucroferric oxyhydroxide
CAS Number: 8047-67-4, Molecular Weight: varies, Chemical Formula:varies, EINECS EC Number: 232-464-7, FEMA: ----,
The names and CAS number for Iron sucrose and Iron saccharate are interchangably used and often there is a confusion.
General Specifications of Iron Sucrose:
Appearance: Reddish deep brown colored amorphous Powder, with characteristic odor and hygroscopic in nature.
Solubility: 10 % w/v Easily soluble in water.
Molecular Weight Determination (By GPC):
(a) The Weight Average Mol. Wt. (Mw): 34,000 - 60,000Da
(b) The No. Average Mol. Wt. (Mn): 24,000 Da.
(c) Index (Mw/Mn): Maximum 1.7
Loss On Drying: 5% maximum at 105C.
Tapped Bulk Density: Between 0.65 and 1.2 w/v.
Specific Gravity at 20C for ( 2%w/v Iron Solution): 1.135 TO 1.165
Bacterial Endotoxin Test: 3.7 EU/mg of Iron maximum.
Alkalinity ( 2%w/v Iron Solution): Minimum 0.5 and Minimum 0.8 mI of 0.1 N HCl
pH (2%w/v Iron Solution): 9.5 to 11.1
Chloride: Between 335 ppm and 720 ppm.
Water: 5% maximum.
Osmolarity ( 2%w/v Iron Solution): Minimum 1150 mOsmollLit. Minimum NMT 1350 mOsmollLit.
Absence of low Mol. Wt. Fe(II) & Fe(III) (2% w/v Iron solution): No additional peaks are found in polarogram in the test for limit of Fe (II).
Turbidity (2 %w/v Iron Solution): Turbidity should develop between pH 4.4 - 5.3
Limit of Iron(II): Maximum 1%.
Assay of Sucrose By HPLC (2% w/v Iron solution): 79% to 91%.
Assay of Iron on dry basis: Minimum 4.8 % w/w and Maximum 6.4 % w/w.
Total Bacterial count: Maximum 500 CFU/g
Total Yeast mould: Maximum 100 CFU/g
Bacterial Endotoxin: Maximum 100 CFU/g
Total Fungal count: Maximum 50 CFU/g
E. Coli: Absent.
Staphylococcus aureus: Absent.
Pseudomonas aeruginosa: Absent.
Residual Solvent: Maximum 3000 ppm.
Cadmium: Maximum 5 ppm.
Lead: Maximum 5 ppm.
Arsenic: Maximum 3 ppm.
Specifications of Iron Sucrose Injection USP Grade Specifications:
Iron Sucrose Injection is a sterile, colloidal solution of ferric hydroxide in complex with Sucrose in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of iron. Sodium Hydroxide may be added to adjust the pH. It contains no antimicrobial agent, chelating agent, dextran, gluconate, or other added substances.
Packaging and storage: Preserve in single-dose containers of Type I glass. Store at controlled room temperature. Do not freeze.
Complies with specifications of USP Monograph.
Specifications of Iron Sucrose Injection BP Ph Eur Grade Specifications:
Action and use: Treatment of iron-deficiency anaemia.
Iron Sucrose Injection is a sterile colloidal solution containing a complex of iron(III) hydroxide with sucrose of average molecular weight between 34000 and 60000.
Iron Sucrose Injection is produced by a method of manufacture designed to provide an iron-sucrose complex with appropriate iron absorption characteristics. This may be confirmed for routine control purposes by the use of an appropriate combination of physico-chemical tests, subject to the agreement of the competent authority.
A suitable test is carried out to demonstrate (1) the amount of iron(II) present in the injection is not more than 0.4% w/v of the total iron content and (2) there are no low molecular weight complexes in the injection.
The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.
Content of iron, Fe: 95.0 to 105.0% of the stated amount.
Content of sucrose: 90.0 to 110.0% of the stated amount.
A. To a quantity of the injection containing the equivalent of 20 mg of iron, add 20 mL of water and 5 mL of hydrochloric acid and boil for 5 minutes. Cool, add an excess of 13.5M ammonia and filter. Wash the precipitate with water, dissolve in the minimum volume of 2M hydrochloric acid and add sufficient water to produce 20 mL The resulting solution yields reaction B characteristic of iron salts.
B In the Assay for Sucrose, the retention time of the principal peak in the chromatogram obtained with solution (1) corresponds to that of the principal peak in the chromatogram obtained with solution (2).
C. Complies with the test for Molecular weight determination.
Complies with specification of BP Ph monograph.
Keywords: Iron Sucrose & Iron D Saccharate Ferric hydroxide sucrose complex, Iron oxide saccharated, Iron saccharate, Iron sucrose, Iron sucrose complex, Iron sugar, Iron(III) hydroxide sucrose complex, Saccharated ferric oxide, Saccharated iron, Saccharated iron oxide, Sucroferric oxyhydroxide IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.
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Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 23726950, +91 22 23774610, +91 22 23723564
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Last updated 21-dec-22
Exporters to USA, Canada, UAE, Europe, South Africa, Tanzania, Kenya, Egypt, Turkey, Nigeria, Uganda, Brazil, Chile, Argentina, Dubai, Cameroon, Mexico, Brazil, Chile, Argentina, Korea, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, etc.
Representatives in New York, Houston - Texas, Chicago - Illinois, Los Angeles.
All products are Sold for Industrial Use only. No other use is permitted. Specifications provided are for reference. Grade approvals pending.
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