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Hydroxypropyl methyl cellulose phthalate

CAS Number
9050-31-1
EC Number
618-567-3
Chemical Formula
C8H6O4.xC3H8O2.xCH4O.xUnspecified
Molecular Weight
240.30 g/mol

Description

Hydroxypropyl methyl cellulose phthalate ( CAS 9050-31-1 ), commonly known as HPMCP, is a cellulose-based enteric polymer used in pharmaceutical manufacturing. It forms acid-resistant films that dissolve at defined pH thresholds in the intestinal tract. This material enables controlled drug release without gastric degradation, ensuring the integrity of the dosage form. HPMCP is the primary enteric coating material for tablets and capsules where active ingredients must bypass the stomach. It is essential for protecting acid-sensitive APIs such as proton pump inhibitors and certain biologics. In solid dosage form development, it is used in both film coating and hot-melt extrusion processes to engineer delayed-release profiles. Formulators also incorporate it into enteric matrix granules and multiparticulate systems for modified-release oral drug products. Its defined dissolution pH range makes it a specification-critical excipient in generic drug development. HPMCP is supplied as a white to off-white powder in standard pharmaceutical grades. Two primary grades are commercially recognized, HP-50 and HP-55, which are differentiated by their specific pH dissolution thresholds. These grades offer thresholds of approximately 5.0 and 5.5 respectively to meet diverse formulation needs. Material is available to Ph.Eur. , USP /NF, and JP specifications for global regulatory compliance. The product is supported by comprehensive documentation packages suitable for IND and NDA filings. This ensures that manufacturers can meet the rigorous quality standards required for modern pharmaceutical applications. Contact us for supply of Hydroxypropyl methyl cellulose phthalate Request Quote

Other Names (Synonyms)

IMIQUIMOD | Aldara | Zyclara | 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine | 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine | 4-Amino-1-isobutyl-1H-imidazo[4,5-c]quinoline | R 837 | S-26308

Key Technical Features

  • High Purity Grade standard
  • Consistent Batch Quality
  • Full Regulatory & REACH Support
  • Global Logistics Network enabled

Physical Properties

Melting Point145 °C (approx)
Density1.277 g/cm³
AppearanceWhite to off-white free-flowing flakes or granules
Formneat

Safety & Handling

Danger
GHS06· ToxicGHS07· Irritant

Hazard Statements

H300
H300
H315
H315
H319
H319
H335
H335
H413H413

Precautionary Statements

P261
P261
P264
P264
P270
P270
P271
P271
P273
P273
P280
P280
P319
P319
P321
P321
P330
P330
P405
P405
P501
P501
P265
P265
P316
P316
P352
P352
P340
P340
P317
P317
P317
P317
P364
P364
P233
P233
P338

Trade & Regulatory

HS Code39129090
Storage Class11 - Combustible Solids
WGK (Germany)1