croscarmellose sodium Pharmaceutical Chemicals

Location:
Hangzhou, China ( Mainland)
Status:
New
Sample Availibility:
yes
Payment Terms:
Cash, Bank Transfer, Letter of Credit, T/T, L/C

Product Description

Croscarmellose sodium is an internally cross-linked sodium carboxymethylcellulose for use as a disintegrant in pharmaceutical formulations.

The cross-linking reduces water solubility while still allowing the material to swell (like a sponge) and absorb many times its weight in water. As a result, it provides superior drug dissolution and disintegration characteristics, thus improving formulas' subsequent bioavailability by bringing the active ingredients into better contact with bodily fluids.

Croscarmellose sodium also resolves formulators' concerns over long-term functional stability, reduced effectiveness at high tablet hardness levels, and similar problems associated with other products developed to enhance drug dissolution. Croscarmellose sodium is a very commonly used pharmaceutical additive approved by the U.S. Food and Drug Administration (FDA). Its purpose in most tablets - including dietary supplements - is to assist the tablet in disintegrating in the intestinal tract at the required location. If a tablet disintegrating agent is not included, the tablet could disintegrate too slowly, or in the wrong part of the intestine or not at all, thereby reducing the efficacy and bioavailability of the active ingredients.

Croscarmellose sodium is made by first soaking crude cellulose in sodium hydroxide and then reacting the cellulose with sodium monochloroacetate to form sodium carboxymethylcellulose. Excess sodium monochloroacetate slowly hydrolyzes to glycolic acid and the glycolic acid catalyzes the cross-linkage to form croscarmellose sodium. Chemically, croscarmellose sodium is the sodium salt of a cross-linked, partly O-(carboxymethylated) cellulose.

Batch No.

110103

MFG DATE

JAN.22,2011

Packing

5kg/bag

EXP DATE

JAN.21,2013

Tests

Standard USP

Results

Characters

A White free flowing powder

Conforms

Identification A,B,C

Positive

Conforms

PH

5.0-7.0

5.9

Loss on Drying %

Not more than 10.0

2.7

Na-chloride&Na-glycolate %

Not more than 0.50

0.19

Heavy metals (ppm)

Not more than 10

Conforms

Degree of Substitution

0.60-0.85

0.72

Water-soluble substances (%)

Not more than 10.0

8.6

Settling volume

10.0-30.0

16.0

Retained 200 mesh(74Microns)

Not more than 10.0

3.6

Residue on ignition

14.0-28.0

15.6

Total aerobic microbial count

Not more than 100cfu/gm

Conforms

Total molds and yeasts count

Not more than 20 cfu/gm

Conforms

Escherichia coli

Absence

Conforms



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Contact Information

Company:
 Hangzhou Ruijiang Chemical Co., Ltd.
Phone Number:
  0086-0571-88914509
Fax Number:
 0086-0571-88854175