POLYQUID PA-30 is a water dispersion
type coating agent for enteric coated preparations.
This product corresponds as follows:
Drug Master File (DMF):
This product is registered with DMF for the Food and
Drug Administration (FDA) as "POLYQUID PA-30"
in the U.S.A.
United States Pharmacopeia / National
Formulary (USP/NF):
Methacrylic acid Copolymer Dispersion
European Pharmacopoeia (EP):
Methacrylic acid - Ethyl acrylate copolymer (1:1) dispersion
30 per cent
Japanese Pharmaceutical Excipients
(JPE):
Methacrylic Acid Copolymer LD |
|
| 1. Outline for
POLYQUID PA-30 |
|
|
This product is a
dispersion of copolymer that is produced using
methacrylic acid and ethyl acrylate in an aqueous
solution consisting of POLYSORBATE 80 and sodium
lauryl sulfate. |
|
|
Chemical
Name : Dispersion of poly[(methacrylic
acid)-co-(ethyl acrylate)] |
|
|
Structural
Formula : |
|
|
|
|
| 2. Application |
|
|
This product can
be used as an enteric-soluble coating, binders
for matrices, masking pungency, etc. |
|
|
| 3. Features |
|
| |
 |
This
product is a water dispersion type coating agent
which does not contain organic solvents. |
|
|
This
product is made from vegetable materials. |
|
|
The
quantity of bacteria, fungi and Escherichia coli
are controlled in this product. |
|
|
| 4. Properties
(values described in JPE) |
|
|
Values
Described in JPE |
| Description |
POLYQUID
PA-30 is a white emulsion, characteristic odor,
and slightly acidic taste. |
Solubility:
Freely soluble in ethanol and acetone, and practically
insoluble in ether.
Disperses homogeneously in water.
Dissolves in dilute sodium hydroxide TS. |
| Identification(1)(2)(3) |
Conforming |
| Viscosity |
3-15
mm2/s (Method
, 20°C) |
| pH |
2.1-3.1 |
| Specific
gravity |
1.055 - 1.080 (d20/20) |
| Purity
|
(1)Heavy
metals |
<
10 ppm |
| (2)Arsenic |
<
1 ppm |
| (3)Ethyl
acrylate |
<
100 ppm |
| Residue
on evaporation |
27.0
- 33.0 wt % |
| Residue
on ignition |
<
0.10 wt % |
| Assay
(as methacrylic acid) |
11.5
- 15.5 % |
|
|
|
|
|
