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TYLOPUR® 645

TYLOPUR® 645 is a versatile hypromellose, compliant with USP, JP, EP. It is a film coating material that provides an excellent finish.It is a effective binder, it does not interact with drugs.It also enhances the solubility of poorly solule APIs.

Brand: TYLOPUR (33 products)

Chemical Name: Hydroxypropyl Methylcellulose

Functions: Binder, Thickener, Viscosity Modifier

Dosage Form: Capsules, Orally Disintegrating Films (ODFs), Pellets, Tablets

Labeling Claims: Allergen-free, Halal, Kosher, Non-GMO, Plant-Based

Certifications & Compliance: EU Compliant, EXCiPACT, European Pharmacopeia (Ph. Eur.), FCC Compliant, FDA Compliant, FSSC 22000, GMP, Generally Recognized As Safe (GRAS), Halal, ISO 14001, ISO 9001, Japan Pharmacopeia (JP), Kosher, United States Pharmacopeia (USP)

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name
Hydroxypropyl Methylcellulose
Pharma & Nutraceuticals Functions
Binder,
Thickener,
Viscosity Modifier
CAS No.
9004-65-3
EC No.
618-389-6
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Binders & Disintegrants,
Formulation & Processing Aids

Features & Benefits

Labeling Claims
Allergen-free,
Halal,
Kosher,
Non-GMO,
Plant-Based

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Healthcare & Pharma — Pharmaceutical Manufacturing
Excipients & Coatings
Dosage Form
Capsules,
Orally Disintegrating Films (ODFs),
Pellets,
Tablets
Manufacturing Technology
Tablet Coating

Properties

Physical Form
Powder,
Solid
Typical Properties
ValueUnitsTest Method / Conditions
Heavy Metalsmax. 20ppm-
Hydroxypropoxy Content7.0 - 12.0%-
Loss on Dryingmax. 5.0%-
Methoxy Content28.0 - 30.0%-
pH5.0 - 8.0EP
Sulphated Ash /Residue On Ignitionmax. 1.5%EP
Visocity3.6 - 5.1mPas-
Coating Properties
ValueUnitsTest Method / Conditions
Inlet Air Flow (Coating Parameters)Constantm3/h-
Inlet Air Flow (Coating Parameters)400.0m3/h-
Inlet Air Temperature (Coating Parameters)80.0⁰C-
Nozzle Pressure Bar (Coating Parameters)0.65bar-
Nozzle Pressure Bar (Coating Parameters)2.9bar-
Pan Speed (Coating Parameters)22.0rpm-
Pan Speed (Coating Parameters)5 (during 5min) - 12rpm-
Spray Rate (Coating Parameters)4.2 - 5.9g/min-
Spray Rate (Coating Parameters)6 - 23g/min-
Tablet Bed Temperature during Coating38 - 40⁰C-
Tablet Bed Temperature during Coating35 - 40⁰C-
Tablet Bed Temperature during Coating40.0⁰C-
Processing Parameters
ValueUnitsTest Method / Conditions
Disintegration Time474.0S-
Dissolution(>80%) min10.0--

Regulatory & Compliance

Certifications & Compliance
EU Compliant,
EXCiPACT,
European Pharmacopeia (Ph. Eur.),
FCC Compliant,
FDA Compliant,
FSSC 22000,
GMP,
Generally Recognized As Safe (GRAS),
Halal,
ISO 14001,
ISO 9001,
Japan Pharmacopeia (JP),
Kosher,
United States Pharmacopeia (USP)
Chemical Inventories
AICS (Australia),
DSL (Canada),
ENCS (Japan),
KECI (Korea),
NZIoC (New Zealand),
PICCS (Phillipines),
TCSI (Taiwan),
TSCA (USA)
Grade
Pharma Grade

Packaging & Availability

Packaging Type
Bags,
Boxes