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INSTACOAT E-SERIES New

READY-TO-USE FILM COATING

PHARMA ACRYLIC POLYMERS

COOLING COMPOUNDS

NEUTRAL SPHERES

R & D COATER

FILM COATING - NUTRACEUTICALS

CONTROLLED RELEASE PRODUCTS

BRANDING SOLUTIONS

Espheres EM

Ecospheres logo

ESPHERES EM (Microcrystalline Cellulose Spheres)

MCC (Micro Crystalline Cellulose) spheres are hard and brittle spherical masses composed mainly of MCC or a combination of major MCC and lactose.

Definition:

  • ESPHERES EM contains not more than 80% of Microcrystalline Cellulose, calculated on the dried basis
  • Microcrystalline Cellulose complying with Ph.Eur., USP/NF and JP
  • Produced in accordance with cGMP

Composition:

  • Micro Crystalline Cellulose

Features:

  • Uniform sphere size
  • Low friability/solubility
  • Higher yield of final product
  • Uniform and consistent loading
  • Cost effective
  • Lactose/Starch Free

General and microbiological information:

Loss on drying – NMT 7%
Total Plate Count – NMT 1000/g
pH – 5 to 7.5 (supernatant liquid)
Residue on ignition – ≤ 0.1%
Heavy metals – ≤ 10ppm
Salmonella – Absent
E.coli – Absent
Pseudomonas aeruginosa – Absent
Staphyloccus aureus – Absent
Yeast and Mould count – NMT 100/g

Re-evaluation Date - 36 months from the date of manufacture.

Application:

Adapted for controlled release or sustained release formulations to produce spherical granules which have the most suitable size and dissolution profile

Particle Size (U.S. Standard Sieve) and specifications:

Product
12/14
14/16
16/18
18/20
20/25
25/30
30/35
35/40
40/60
ESPHERES EM
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  • All intermediates ESPHERES are available on request.
  • Not less than 90% of it passes the coarser sieve size stated in the labeling available on request.
  • Not more than 10% passes the finer sieve size stated in the labeling. All of it passes the next coarser sieve listed in test procedure.

For more details about ESPHERES™ products, please contact us at info@idealcures.co.in