Description

Poly(Vinylacetate Phthalate) CAS NO 53237-50-6 is a synthetic polymer specifically designed as an enteric coating agent for pharmaceutical dosage forms. Its primary value lies in its pH-dependent solubility, which ensures the safe and targeted delivery of active pharmaceutical ingredients (APIs) to the intestinal tract. This makes it a critical excipient for formulators and manufacturers in the pharmaceutical industry seeking to protect acid-labile drugs or prevent gastric irritation.

Application

• Enteric Coating for Solid Oral Dosage Forms: Primary use for tablets and capsules to prevent drug release in the stomach (pH 1-3) and ensure dissolution in the higher pH environment of the small intestine (pH 5.5+).
• Protection of Acid-Labile Active Pharmaceutical Ingredients (APIs): Shields drugs that degrade or become inactivated in the acidic gastric fluid, enhancing drug stability and bioavailability.
• Gastric Irritation Mitigation: Used to coat drugs that can cause nausea, bleeding, or other adverse effects on the gastric mucosa by delaying release until the intestine.
• Controlled and Targeted Drug Delivery Systems: A key polymer in the formulation of delayed-release and site-specific delivery mechanisms.
• Pharmaceutical Excipient in Film Coating: Employed in aqueous or organic solvent-based coating solutions and suspensions for uniform film formation.
• Research & Development of Novel Drug Formulations: Used in pre-formulation studies and the development of new enteric-coated generics or specialty pharmaceuticals.

Basic Information

Product Name	Poly(Vinylacetate Phthalate)
CAS No.	53237-50-6
Molecular Formula	(C14H14O7)n
Molecular Weight	~ 50,000 (Typical average, grade dependent)
Synonyms	Polyvinyl Acetate Phthalate; PVAP; 1,2-Benzenedicarboxylic Acid, Polymer with Ethenyl Acetate; Vinyl Acetate – Phthalic Anhydride Copolymer; Coating Agent, Enteric; Eudragit® Alternative (Enteric); Phthalate Enteric Coating Polymer; PVA Phthalate; VAP
EINECS	Contact for details

Quality Control

Our Poly(Vinylacetate Phthalate) is manufactured under strict quality management systems to ensure batch-to-batch consistency suitable for pharmaceutical applications. Quality is verified through comprehensive testing including identification, assay, viscosity, phthalic anhydride content, and residual solvents. A Certificate of Analysis (COA) is provided with each batch, confirming compliance with in-house specifications developed in alignment with ICH Q3 and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive). Keep the container tightly sealed after each use to minimize exposure to atmospheric moisture, which can affect its performance in coating formulations.

Specification

Item	Specification
Appearance	White to off-white free-flowing powder
Identification (IR)	Conforms to reference spectrum
Assay (as Phthalyl Content)	55.0 - 62.0 %
Viscosity (10% in Acetone/Ethanol)	5.0 - 15.0 mPa·s
Loss on Drying	≤ 5.0 %
Residue on Ignition	≤ 1.0 %
Free Phthalic Acid	≤ 1.0 %
Residual Solvents (GC)	Meets ICH Q3C limits

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.