FE109, Ferrous Gluconate, USP

Scientific Documentation

FE109, Ferrous Gluconate, USP

Not appropriate for regulatory submission. Please visit or contact Tech Services for the most up-to-date information contained in this information package.

Spectrum Chemical Mfg Corp

769 Jersey Avenue New Brunswick, NJ 08901 Phone 732.214.1300

Ver4.06 07.July.2022

FE109, Ferrous Gluconate, USP

Table of Contents

Product Specification

Certificate of Analysis Sample(s)

Safety Data Sheet (SDS)

Certification of Current Good Manufacturing Practices (cGMP)

Manufacturing Process Flowchart

Source Statement

BSE/TSE Statement

Allergen Statement

EU Fragrance Allergen Statement

GMO Statement

Melamine Statement

Nitrosamine Statement

Animal Testing Statement

Organic Compliance Statement

Shelf Life Statement

Other Chemicals Statement

Elemental Impurities Statement

Residual Solvents Statement

General Label Information ? Sample Label

 General Lot Numbering System Guidance

Kosher Certificate

Halal Certificate

Item Number Item CAS Number Molecular Formula Molecular Weight MDL Number Synonyms

Specification for Ferrous Gluconate, USP (FE109)

FE109 Ferrous Gluconate, USP 12389-15-0 C12H22FeO14?2H2O 482.17

Iron (II) Di(D-gluconate)

Test

ASSAY (DRIED BASIS) LOSS ON DRYING CHLORIDE (Cl) SULFATE OXALIC ACID ARSENIC (As) FERRIC IRON (Fe o) LEAD (Pb) MERCURY REDUCING SUGARS ELEMENTAL IMPURITIES: COBALT (Co)

IDENTIFICATION (TLC)

IDENTIFICATION (B) CERTIFIED KOSHER CERTIFIED HALAL APPEARANCE RETEST DATE DATE OF MANUFACTURE RESIDUAL SOLVENTS MONOGRAPH EDITION

Specification Min 97.0 6.5

NO TRUBIDITY IS PRODUCE WITHIN 5 MINS

NO RED PRECIPITATE IS FORMED WITHIN 1 MIN

AS REPORTED SAMPLE PRINCIPLE SPOT IN

COLOR, SIZE, Rf VALUE CORRESPOND WITH REFERENCE

POSITIVE FOR FERROUS IRON

Max 102.0 % 10.0 % 0.07 %

0.1 %

3 ppm 2.0 % 10 ppm 3 ppm

AS REPORTED

Spectrum Chemical Mfg Corp

Corporate Headquarters: West Coast Facility:

769 Jersey Ave.

14422 S. San Pedro St.

New Brunswick, NJ 08901 Gardena, CA 90248

732.214.1300

310.516.8000

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