TYLOPUR CLEARCOAT NUTRA® 5

Identification & Functionality

Chemical Name

Hydroxypropyl Methylcellulose

Pharma & Nutraceuticals Functions

Binder,

Coating System,

Supplement

CAS No.

9004-65-3

EC No.

618-389-6

Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Binders & Disintegrants,

Pharmaceutical Coatings

Features & Benefits

Labeling Claims

Allergen-free,

BSE-free,

GMO-free,

Gluten-free,

Halal,

Irradiation-free,

Kosher,

Lactose-free,

Plant-Based,

TSE-free,

Vegan

Benefits

Your tablets gain an easily made coating with only two natural ingredients: Plant derived Tylopur Clearcoat Nutra ® and water ... Naturally clear choice!

• Your tablets have a brilliant, transparent and shiny finish.
• Your active ingredient is protected against humidity.
• Your tablets are less friable during packaging.
• Your consumers enjoy the improved swallowability.

Besides tablet coating, adding Tylopur Clearcoat Nutra ® to your granulation process improves particle size, flow and compactibility of your active ingredient for tablet compression.

High Quality

Manufactured in Germany, Tylopur Clearcoat Nutra ® is a plant derived product that complies to European and US guidelines and guarantees exclusion of non-conforming ingredients (dioxides, stearates).

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Oral

Healthcare & Pharma — Pharmaceutical Manufacturing

Excipients & Coatings

Dosage Form

Tablets

Manufacturing Technology

Direct Compression,

Wet Granulation

Formulation Example

• Tylopur Clearcoat Nutra ® 5 was dissolved in water at room temperature within 45 minutes.
• A homogenous tablet coating is achieved with maximal 3% polymer weight gain.

Properties

Physical Form

Powder,

Solid

Odor

Odorless

Taste

Flavorless

Appearance

Powder

Composition

	Value	Units	Test Method / Conditions
Methoxy Content	28.0 - 30.0	%	—
Hydroxpropoxy Content	7.0 - 12.0	%	—

Regulatory & Compliance

Certifications & Compliance

California Proposition 65,

EXCiPACT,

European Pharmacopeia (Ph. Eur.),

FCC Compliant,

FSSC 22000,

GMP,

Generally Recognized As Safe (GRAS),

Gluten-free,

Halal,

Hazard Analysis Critical Control Point (HACCP),

ISO 14001,

ISO 45001,

ISO 50001,

ISO 9001,

Japan Pharmacopeia (JP),

Kosher,

REACH Exempt (Europe),

United States Pharmacopeia (USP),

Vegan

Chemical Inventories

AICS (Australia),

EEC/EU ,

EINECS (EU),

ENCS (Japan),

IECSC (China),

KECI (Korea),

NZIoC (New Zealand),

PICCS (Phillipines),

TCSI (Taiwan),

TSCA (USA)

Grade

Pharma Grade

Packaging & Availability

Packaging Type

Bags,

Cartons

Packaging

The carton box packaging consists of an inner polyethylene (PE) bag and an outer carton box. The inner PE bag is sealed with an irreversible plastic tie. The outer carton box is sealed with a tamper proof, adhesive tape. Each component of the Carton box packaging is new material, not recycled.

Storage & Handling

Shelf Life

3 years

Expiration Date and/or Recommended Re-Evaluation Interval

Re-evaluation date:

• The date after 3 years from the manufacturing date.
• If used after the re-evaluation date, it is recommended to analyze the quality of Tylopur® before use.

Storage and Shipping Conditions

Keep dry. Store in sealed original packaging and away from excess heat and sunlight.