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Cross Carmellose Sodium

Croscarmellose sodium is an internally cross-linked sodium carboxymethylcellulose for use
as a super disintegrant in pharmaceutical formulations. E468 is the E number of crosslinked
sodium carboxymethyl cellulose, used in food as an emulsifier.

Specification

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Description
Free flowing powder, Very hygroscopic powder
color
white
Solubility
Practically insoluble in Acetone,Ethanol,Ether and Toluene
Identification (A,B,C) , (1,2,3)
Have to correspond as USP/NF,JP,Ph.Eur.,BP
Degree of Substitution
0.60 to 0.85 as
USP/NF,JP,Ph.Eur.,BP
Loss on Drying
NMT 10.0% as
USP/NF,JP,Ph.Eur.,BP
pH
5.0-7.0 as
USP/NF,JP,Ph.Eur.,BP
Content of water Soluble Substance
NMT 10.0 % as
USP/NF,JP,Ph.Eur.,BP
Residue on Ignition / Sulphated Ash
14.0% to 28.0% as
USP/NF,JP,Ph.Eur.,BP
Settling Volume
10 to 30 ml as
USP/NF,JP,Ph.Eur.,BP
Sodium Chloride & Sodium Glycollate
NMT 0.5 % as
USP/NF,,Ph.Eur.,BP
Heavy Metals
NMT 10 PPM as
USP/NF, Ph.Eur.,BP
Iron
NMT 10 PPM as
USP/NF, Ph.Eur.,BP

MICROBIAL LIMITS

Total Viable Aerobic Count
N.M.T 1000 CFU/gm as
USP/NF,Ph.Eur.,BP
Total yeast & Mould Count
N.M.T 100 CFU/gm as
USP/NF,Ph.Eur.,BP
Staphylococcus aureus
Absent as
USP/NF,Ph.Eur.,BP
Escherichia Coli.
Absent as
USP/NF,Ph.Eur.,BP
Pseudomonas aeruginosa
Absent as
USP/NF,Ph.Eur.,BP
Salmonella species
Absent as
USP/NF,Ph.Eur.,BP

Application

  • Rapid disintegrator in pharmaceutical formulations for tablets, capsules and granules.
  • ACROCEL is effective for combination with both insoluble and filler-binders, such as MCC and DCP.
  • It can also be preferred for non-starch base formulation product.
  • Tablet dissolution can be greatly increased by the use of a super disintegrate.
  • Efficient for low use of levels.
  • Insensate hardness of tablet.
  • Finer dissolution stability for long term.
  • Used in solid dosages vitamin and nutrition.

Storage & Packing

PackSize: 20/25 KGS 
   A. Exportworthy paper bags. 
   B. Fiber pack drum 
   C. Corrugated box 
   C. HDPE Drums 

Packing is done as required by the end user, and all above said options contains inside LDPE liner.

Container

       Paper Bag                                  

       Corrugated box                                  

       Fiber Drums                                  

       HDPE Drums                                  
 

   Palletized

   Non-pal

   Palletized

   Non-pal

   Palletized

   Non-pal

   Palletized

   Non-pal
 

    20 KG

   20 KG

    20 KG

   20 KG

   25 KG

   25 KG

   25 KG

   25 KG

 20″ Feet

  10000 appx.

  12,000 appx.

   9000 appx

  10,000 appx.

   6000 kgs

  8400 kgs

   6000 kgs

   8400 kgs

 40″ Feet

  20,000 appx.

  24,000 appx.

   18,000 appx.

  17,500 appx.

  16,000 kgs

  16800 kgs

  16,000 kgs

  16800 kgs

Pharmacopoeia

  • USP/NF
  • JP
  • PH.EUR
  • BP
  • EP
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