Plot No-C1-1031-9, GIDC Estate, Panoli, Ankleshwar, Gujarat - 393002. India
Telephone Mobile: 91-7506449333; e-mail: info@crystalclearproducts.orgAluminum Chloride Hexahydrate ---- Aluminium Potassium Sulphate ---- Aluminum Chlorohydrate ---- Aluminium Glycinate ---- Aluminium Magnesium Silicate ---- Dried Aluminium Phosphate ---- Dihydroxyaluminum Aminoacetate ---- Dihydroxyaluminum Sodium Carbonate ---- Aluminum Gluconate ---- Aluminum Monostearate & Aluminum Distearate ---- Aluminium Isopropoxide ---- Copper Cupric Chloride ---- Copper Sulfate ---- Ferric Ammonium Citrate ---- Ferric Chloride Hexahydrate ---- Ferric Nitrate Nonahydrate ---- Ferric Oxide ---- Ferric Sulfate ---- Ferrous Fumarate ---- Ferrous Gluconate ---- Ferrous Sulfate ---- Iron Aspartate ---- Iron Sulphide ---- Iron D Saccharate and Iron Sucrose
Ferric Saccharate Iron D Saccharate Iron Sucrose Specifications of Commercial Pure & BP Ph Eur USP Supplements Grade Manufacturers & Exporters
Ferric Saccharate Iron D Saccharate Iron Sucrose CAS Number 8047-67-4General 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.
Salmonella: 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.Complies with specifications of USP Monograph.
Specifications of Iron Sucrose Injection BP Ph Eur Grade Specifications:
Action and use: Treatment of iron-deficiency anaemia.DEFINITION
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.PRODUCTION
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.Complies with specification of BP Ph monograph.
Crystal Clear Products and the group companies are manufacturing chemicals since several decades. We have automatic vacuum operated titanium evaporators and SS316 equipments to produce top grade of chemical products. We have toll manufacturers and representatives in China, UAE, Europe, Canada & USA and agents & customers in all countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Bangkok Thailand, Kaula Lumpur Malaysia, Dubai UAE etc. & sales representative in Chicago, Houston New York & Los Angeles, USA. Associated units are FDA-GMP certified, Halal and/or Kosher certified, REACH registered, ISO-9001, ISO-22000 HACCP certified, Crisil Rated.
Contact Ferric Saccharate Iron D Saccharate Iron Sucrose IP BP Ph Eur EP JP USP NF ACS Analytical Reagent FCC Food Grade manufacturers exporters at:
Crystal Clear Products
Plot No-C1-1031-9, GIDC Estate, Panoli, Ankleshwar, Gujarat - 393002. India
Telephone Mobile: 91-7506449333; e-mail: info@crystalclearproducts.orge-mail: info@crystalclearproducts.org
Manufacturers, Suppliers of IP BP Ph Eur EP JP USP NF FCC Food, ACS Reagent GMP Grades of Chemicals like Ferric Saccharate Iron D Saccharate Iron Sucrose