Quick Details
- ProName: Ferrous gluconate
- CasNo: 299-29-6
- Molecular Formula: C12H22FeO14
- LimitNum: 0
Superiority
Analytical Specifications for Ferrous Gluconate USP (Dihydrate)
Test
Limits (As per USP 29)
Description
: Yellowish gray or pale greenish yellow, fine powder.
Solubility
: So…
Details
Analytical Specifications for Ferrous Gluconate USP (Dihydrate)
Test
Limits (As per USP 29)
Description
: Yellowish gray or pale greenish yellow, fine powder.
Solubility
: Soluble in water with slight heating.
Practically insoluble in alcohol.
Identification
: Shall pass the test
Loss on Drying (1050C for 16 hours)
: 6.5 to 10.0%
Chloride
: Max. 0.07%
Oxalic acid
: Shall pass the test.
Sulphate
: Max. 0.1%
Arsenic
: Max.2 ppm
Ferric Iron
: Max. 2.0%
Mercury
: Max. 3 ppm
Reducing Sugars
: Shall pass the test
Organic volatile impurities
: Shall pass the test
Assay as C12H22FeO14 (Calculated on dried basis)
: 97.0% to 102.0%
Additional Tests (In-House)
Lead : Max. 5 ppm
pH : 4.0 - 5.5
Mineral Content : 11.8 % to 12.5 %
Bulk density (Loose Kg/m3) : 550 to 700 Kg/m3
Particle Size
# 40 (US) mesh (pass through) : Minimum 90.0 %
Microbial Limit Tests:
Total aerobic count : Max. 1000 CFU/g
Total moulds and yeasts
: Max. 100 CFU/g
E.Coli : Absent
Salmonella : Absent
1. Method of testing as per USP 29 as applicable.
2. In-house specs - Method of testing available on request.
3. MSDS - Available on request.
Other:
Shelf life : 3 years from date of manufacturing.
Storage condition : Preserve in a sealed container at temperature between 20-250C.
Manufacturing Condition : WHO cGMP approved.
Quality Certification : ISO, USFDA, EDQM, cGMP, EU-Compliance, HACCP, KOSHER – StarK PAREVE Status, HALAL & ICH-Q7A.
Packaging Units : Products can be supplied in packaging ranging from 20 kgs – 50 kgs
Packing : Packing Material options include HDPE Bags Plastic Drums,
Fiber Drums, Fiber Kegs, High Resistance Paper Sacks and High Density Carton with inner HDPE liner sealed air tight.
Dated : 25th September 2006