Cargill Pharm 12011 NGM

Identification & Functionality

Chemical Name

Corn Starch

Country of Origin

United States of America (USA)

Pharma & Nutraceuticals Functions

Binder,

Diluent

CAS No.

9005-25-8

EC No.

232-679-6

Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Binders & Disintegrants,

Fillers & Diluents

Product Label

Package labeling US	Pregelatinized corn starch
Ingredients US [Listed in Descending Order]	100% (ds) Corn starch

Features & Benefits

Labeling Claims

Allergen-free,

Halal,

Kosher,

Non-Carcinogenic,

Non-GMO,

Vegan,

Vegetarian,

Wheat-free

Functionality

This product is a binder that is compatible with most excipients and drugs.

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Oral

Dosage Form

Capsules

Manufacturing Technology

Direct Compression,

Dry Granulation,

Wet Granulation

Application

The product is used in solid dosage formulations as a :

• Diluent/binder in direct compression and wet and dry granulation
• Diluent in capsule and powder formulations

Properties

Physical Form

Capsules,

Powder,

Solid

Typical Properties

	Value	Units	Test Method / Conditions
Identification A	Pass test	—	Ph.Eur. microsc.
Identification B	Pass test	—	Ph.Eur. Iodine
Foreign Matter	Pass test	—	Ph.Eur.
pH	4.5 - 7	—	Ph.Eur.
pH	4.5 - 7	—	USP/NF
Oxidising Substances	Pass test	ppm	Ph.Eur.
Oxidising Substances	Pass test	µgper gram	USP/NF
Loss on Drying	max. 14	%	USP/NF
Residue on ignition	max. 0.5	%	USP/NF

Regulatory & Compliance

Certifications & Compliance

CFIA Amenable,

EU Compliant,

European Pharmacopeia (Ph. Eur.),

FCC Compliant,

FDA 21 CFR Regulations,

FDA Compliant,

Halal,

Kosher,

National Formulary (NF),

Occupational Safety & Health Administration (OSHA),

REACH Exempt (Europe),

The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA),

United States Pharmacopeia (USP)

Chemical Inventories

AICS (Australia),

DSL (Canada),

ECL (Korea),

EINECS (EU),

IECSC (China),

NZIoC (New Zealand),

PICCS (Phillipines),

TSCA (USA)

Grade

Pharma Grade

Dietary Information

Suitable for		Certified
Halal	Yes	Yes
Kosher	Yes	Yes
Lacto-vegetarian	Yes	No
Ovo-vegan	Yes	No
Vegan	Yes	No
Vegetarian	Yes	No

GMO Statement

This Cargill ingredient complies with the EU GMO requirements as principally laid down under EC Regulation No 1829/2003 on 'genetically modified food and feed' and EC Regulation 1830/2003 on 'the traceability and labeling of food and feed products produced from GMO's. Therefore, there is no need to label this product under either 1829/2003 or 1830/2003.

Legal Requirements

• The current European Pharmacopeia version
• In accordance with Section 403(i) of the US Federal FD&C Act, and Section 4 (a)(1) of the Fair Packaging and Labeling Act, the term "starch" is considered the common or usual name for starch made from corn; alternatively, the name "corn starch" may be used.
• Status pursuant to USDA 7 CFR Part 66 National Bioengineered Food Disclosure Standard (“BE” status) : The product has been sourced from a non-bioengineered source and the inadvertent presence of BE is less than 0.9%.
• The current United States Pharmacopeia / National Formulary version
• This product is in compliance with : Current Food Chemical Codex

Packaging & Availability

Packaging Type

Bags

Standard Packaging

50 lb. Multi-ply, PE Lined Paper Bags

Storage & Handling

Shelf Life

24 Months

Recommended Storage Conditions

• Store inside, under dry conditions
• The specified shelf life can only be guaranteed for this product if the above mentioned recommended storage conditions are respected. For products delivered in bulk, there should be a clean storage (and circulation) system, protected from any potential contamination.