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Cross Carmellose Sodium

Croscarmellose sodium is an internally cross-linked sodium carboxymethylcellulose for use as a superdisintegrant in pharmaceutical formulations. E468 is the E number of crosslinked sodium carboxymethyl cellulose, used in food as an emulsifier.
  • Specification
  • Application
  • Storage & Packing
  • Pharmacopoeia

Parameters

Specification

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

 

The raw materials, manufacturing  process, and product do not contain any of solvents listed in Organic Volatile Impurities (USP<467>)  & residual solvents (Ph – Eur<5.4>), except for ethanol limit is max. 3.0%

  • 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.

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

 

HDPE Paper Bag with LDPE Inner Liner

 

Carton Box Packing


 

HDPE Drum packing

 

Fiber Drum Packing

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

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