company tower banner

Roquette 400L-NF Corn Starch - Pharma

Roquette 400L-NF Corn Starch is an oxidized maize starch that can be used as a disintegrant filler and binder (once cooked) in a variety of nutraceutical and pharmaceutical dosage forms, including swallowable tablets, hard capsules, blends, granules and pellets premix. Benefits Acrylamide-free BSE-free Halal and Kosher certified Melamine-free TSE-free Vegan

Chemical Name: Corn Starch, Modified

Functions: Binder, Disintegrant, Filler

Certifications & Compliance: DMF Type II, European Pharmacopeia (Ph. Eur.), FDA IID, FSSAI, FSSC 22000, Halal, ISO 9001, Japan Pharmacopeia (JP), Kosher, National Formulary (NF), United States Pharmacopeia (USP)

Labeling Claims: Acrylamide-free, BSE-free, Halal, Kosher, Melamine-free, TSE-free, Vegan

Technical Data Sheet Safety Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name: Corn Starch, Modified
Pharma & Nutraceuticals Functions: Binder,
Disintegrant,
Filler
CAS No.: 9005-25-8
EC No.: 232-679-6
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Binders & Disintegrants,
Fillers & Diluents

Features & Benefits

Labeling Claims: Acrylamide-free,
BSE-free,
Halal,
Kosher,
Melamine-free,
TSE-free,
Vegan

Applications & Uses

Markets: Healthcare & Pharma
Applications: Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Dosage Form: Capsules,
Granules,
Orally Disintegrating Tablets (ODTs),
Powder & Powder Blends,
Tablets

Properties

Physical Form

Appearance

White Powder

Typical Properties


	Value	Units	Test Method / Conditions
Iron Content	max. 10	mg/kg	-
Loss on Drying	max. 15	%
Oxidizing Substance	max. 20	mg/kg	-
Particle Size (Residue on 75 micron)	max. 2.0	%	-
pH	4.5 - 7.0	-	-
Residue on Ignition	max. 0.5	%	-
Sulfur Dioxide	max. 50	mg/kg	-
Ethanol Content	0	%
Particle Size	5 - 25	μm

Microbiological Values


	Value	Units	Test Method / Conditions
Coliforms	max. 20	CFU/g	-
Escherichia coli	Not detetced	per 10g	-
Escherichia coli	Not Detected	per 10g	-
Pseudomonas	Not detected	per 10g	-
Salmonella	Not Detected	per 10g	-
Total Aerobic Microbial Count	max. 600	CFU/g	-
Staphylococcus aureus	Not detected	per 10g	-
Total Moulds Count	max. 40	CFU/g	-
Total Yeasts Count	max. 20	CFU/g	-

Regulatory & Compliance

Certifications & Compliance: DMF Type II,
European Pharmacopeia (Ph. Eur.),
FDA IID,
FSSAI,
FSSC 22000,
Halal,
ISO 9001,
Japan Pharmacopeia (JP),
Kosher,
National Formulary (NF),
United States Pharmacopeia (USP)
Grade: Pharma Grade
Conformity: Conforms to the current edition of - National Formulary (NF)

Packaging & Availability

Packaging Information

ROQ Product Code: 172251
Article (SKU) Code: 172251966
Package Size & Type: 22.68 kg lined paper bag