Low substituted Carmellose Sodium
MYLCEL®

Ph Eur Nomenclature: Low-substituted sodium carboxymethylcellulose.Sodium salt of a partly O- (carboxymethylated) celluloseUSP Nomenclature: Low-Substituted Carboxymethylcellulose SodiumCellulose, carboxymethyl ether, sodium salt, low-substituted.

Carmellose sodium, low-substituted [9004-32-4].

MYLCEL® is a new addition in the excipients manufactured by Maple biotech Pvt. Ltd. It is low substituted Sodium salt of Carboxymethylcellulose. It imparts very fast disintegration and dissolution of tablets. MYLCEL is manufactured in different grades depending upon Degree of Substitution. At present two grades are available:

1. MYLCEL-10

2. MYLCEL-16

SPECIFICATIONS OF MYLCEL-10

LOW SUBSTITUTED CARBOXYMETHYLCELLULOSE SODIUM SALT

  • Appearance: white to yellowish white, finely fibrous odourless powder

  • Solubility: Practically insoluble in acetone, in anhydrous ethanol and in toluene. It swells in water to form a gel (Ph Eur)

  • Identification:  Shake 2 g of Low-Substituted Carboxymethylcellulose Sodium with 100 mL of sodium hydroxide solution (2M): a suspension is produced. (USPNF & Ph Eur)

  • pH 6.0 to 8.5 (USPNF & Ph Eur)

  • Loss on Drying Max 10% (USPNF & Ph Eur)

  • Residue on Ignition (Sulphated Ash) at 800C: 6.8 to 8.9 (USPNF & Ph Eur)

  • Assay (% Sodium ) 2.2 to 2.9U (SPNF & Ph Eur)

  • Degree of Substitution 0.17 to 0.23

  • Viscosity of 1% solution in 10%NaOH 150 to 400 m.pas

  • Sodium Chloride & Glycolate NMT 0.5% (USPNF & Ph Eur)

  • Water Soluble substanceNMT 18% (USPNF & Ph Eur)

  • Heavy Metals Max 20 ppm (USPNF & Ph Eur)

  • Arsenic Less than 1 ppm (Nymcel) (Not included in USPNF & Ph Eur)

  • Settling Volume15 to 35 ml (USPNF & Ph Eur)

  • Total Aerobic Microbial Count max. 1000 cfu/gm

  • Total Molds and Yeast Count  Max. 100 cfu/ gm

  • E. Coli: absent

  • Salmonella: absent

  • S. Aureus: absent 

  • Pseudomonas: absent

SPECIFICATIONS OF MYLCEL-16

LOW SUBSTITUTED CARBOXYMETHYLCELLULOSE SODIUM SALT

  • Appearance: white to yellowish white, finely fibrous odourless powder

  • Solubility: Practically insoluble in acetone, in anhydrous ethanol and in toluene. It swells in water to form a gel (Ph Eur)

  • Identification:  Shake 1g of Low-Substituted Carboxymethylcellulose Sodium with 100 mL of sodium hydroxide solution (2M): a suspension is produced. (USPNF & Ph Eur)

  • pH 6.0 to 8.5 (USPNF & Ph Eur)

  • Loss on Drying Max 10% (USPNF & Ph Eur)

  • Residue on Ignition (Sulphated Ash) at 800C: 10.8 to 13.3 (USPNF & Ph Eur)

  • Assay (% Sodium ) 3.5 to 4.3U (SPNF & Ph Eur)

  • Degree of Substitution 0.28 to 0.36

  • Viscosity of 1% solution in 10%NaOH 150 to 400 m.pas

  • Sodium Chloride & Glycolate NMT 0.5% (USPNF & Ph Eur)

  • Water Soluble substance NMT 70% (USPNF & Ph Eur)

  • Heavy Metals Max 20 ppm (USPNF & Ph Eur)

  • Arsenic Less than 1 ppm (Nymcel) (Not included in USPNF & Ph Eur)

  • Settling Volume15 to 35 ml (USPNF & Ph Eur)

  • Total Aerobic Microbial Count max. 1000 cfu/gm

  • Total Molds and Yeast Count  Max. 100 cfu/ gm

  • E. Coli: absent

  • Salmonella: absent

  • S. Aureus: absent 

  • Pseudomonas: absent


 
 
 
Specifications MYLCELL16
 
Specifications MYLCELL 10
 
MSDS Mylcel
 
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