TYLOPUR® 60SH-4000

1 of 33 products in this brand
TYLOPUR® is a versatile hypromellose, compliant with USP, JP, EP. TYLOPUR 60SH-4000 provides a genuine consistency in Sustained release (matrix tablets). It also can be used as thickener in aqeous solution .It is also a good suspending agent in colloidal solution.

Chemical Name: Hydroxypropyl Methylcellulose

Functions: Binder, Controlled Release Agent, Sustained Release Agent, Thickener, Viscosity Modifier

Dosage Form: Eye Drops, Suspension, Tablets

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), GMP, Japan Pharmacopeia (JP), United States Pharmacopeia (USP)

    Knowde Enhanced TDS

    Identification & Functionality

    CAS No.
    9004-65-3
    EC No.
    618-389-6
    Structure

    TYLOPUR® 60SH-4000 - Structure

    Features & Benefits

    HPMC Key Quality Attributes in Matrix Tablets
    • Decrease in initial erosion.
    • Slower drug release.
    • No effect on tablet hardness.

    Applications & Uses

    Product Applications
    • Very suitable for thickening
    • Suitable for suspending
    • Liquid and semi-solid
    • Suitable for sustaiined release
    • Suitable for eye drops 
    • Suitable for plaster/dermal patch
    • Very suitable for oral strips

    Properties

    Physical Form
    Appearance
    Conforms
    Typical Properties
    ValueUnitsTest Method / Conditions
    Heavy Metalsmax. 20ppmEP
    Viscosity3000 - 5600mPa.s
    Viscosity50 - 13000mPa.s
    Hydroxypropoxy Content4.0 - 7.5
    Identification (A - E)ConformsEP
    Loss on Dryingmax. 5.0%EP
    Methoxy Content27.0 - 30.0%
    pH5.0 - 8.0EP
    Sulphated Ash/ Residue on Ignitionmax. 1EP

    Regulatory & Compliance

    Regulatory Information
    • EU-Regulations
    1. No REACH Annex XVII restrictions. This product  is not on the REACH Candidate List
    2. This product is not on the REACH Annex XIV List
    3. This product Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH) with its amendment Regulation (EU) 2020/878 SDS No: 10896-0310 16/03/2021 (Revision date) GB - en 8/9
    4. This product is not subject to Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 july 2012 concerning the export and import of hazardous chemicals. This product is not subject to Regulation (EU) No 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants
    5. Contains no substance subject to Regulation (EU) 2019/1148 of the European Parliament and of the Council of 20 June 2019 on the marketing and use of explosives precursors.
    •  National regulations
    1. Listed on the United States TSCA (Toxic Substances Control Act) inventory
    2. Listed on the Canadian DSL (Domestic Substances List)
    3. Listed introduction on Australian Industrial Chemicals Introduction Scheme (AICIS Inventory)
    4. Listed on the EEC inventory EINECS (European Inventory of Existing Commercial Chemical Substances)- Directive 79/831/EEC, sixth Amendment of Directive 67/548/EEC (dangerous substances)
    5. Listed on the Japanese ENCS (Existing & New Chemical Substances) inventory Listed on PICCS (Philippines Inventory of Chemicals and Chemical Substances)
    6. Listed on NZIoC (New Zealand Inventory of Chemicals)
    7. Listed on the TCSI (Taiwan Chemical Substance Inventory) Listed on IECSC (Inventory of Existing Chemical Substances Produced or Imported in China) Listed on KECL/KECI (Korean Existing Chemicals Inventory)

    Packaging & Availability

    Packaging Type
    Packaging Information
    • Fiber drum (40-50 kg) with polyethylene single bag inside of 450 mm x h 740 mm (110 liters).
    • Big bag of 1060 x w 710 x h 1250 mm (up to 1040 liters).

    Storage & Handling

    Storage Information
    • Keep dry. Store away from excess heat and sunlight.
    • Store preferentially in original packaging.