Roquette 400L-NF Corn Starch - Pharma

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

Powder,

Solid

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