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Hypromellose

Hypromellose (HPMC) : A Comprehensive Guide for Advanced Sustained Release Formulations


Product Overview
Hypromellose (HPMC), a semi-synthetic cellulose ether polymer, is widely recognized as a versatile and essential excipient across pharmaceuticals, construction, food science, and cosmetics. Qingdao Acta Biotechnology’s Pharmaceutical Grade HPMC 2910 is engineered to surpass USP and Ph. Eur. standards, offering unmatched performance through its viscosity range of 14.28 mPa·s to over 75,000 mPa·s. This guide explores technical specifications, cross-industry applications, and the unique value of Acta’s HPMC offering, backed by rigorous third-party validation and real-world performance data.

Chemical Properties & Functional Characteristics of hypromellose

  • Chemical Nature: Derived from controlled methylation and hydroxypropylation of natural cellulose, resulting in a hydrophilic polymer with exceptional aqueous solubility (≥98% at 25°C) and film-forming capabilities .
  • Viscosity Range: Unparalleled diversity from 14 mPa·s (low MW) to >75,000 mPa·s (ultra-high MW), enabling precise formulation customization.
  • Thermal Gelation: Forms stable gels at 60–80°C (gelation point: 72.3°C ± 1.5°C), validated in food thickening applications .
  • pH Stability: Maintains structural integrity across pH 3–11, confirmed via spectroscopy in simulated gastric/intestinal fluids.
  • Biocompatibility: FDA GRAS-certified (GRN No. 876), non-toxic, and non-irritating, supported by in vivo studies on dermal and ocular tolerance .

Industry-Specific Applications & Dosage Guidelines of hypromellose

  1. Pharmaceutical Industry
ApplicationDosage RangeFunctionRecommended Viscosity (mPa·s)Supporting Evidence
Tablet Binder1–3% w/wEnhanced hardness (+15–20% vs. MCC)15–100J. Pharm. Sci., 2022
Controlled-Release Matrix15–30% w/wZero-order release over 24h (R²=0.98)4,000–100,000Clin. Pharmacol. Ther., 2021
Film Coating Agent2–5% w/wMoisture barrier (WVTR <0.5g/m²/day)5,000–15,000Acta Biotech Coating Performance Report, 2024
Vegetarian Capsules10–20%Gelatin-free, dissolution <15 min10,000–25,000USP <701> Dissolution Test Compliance
Ophthalmic Lubricants0.3–2.5% w/vProlonged corneal residence time (+40%)14–100Ophthalmic Research, 2023

2.Food Science Applications

  • Thickening Agent: Effective at 0.1–0.5% in sauces/dairy (viscosity increase: 12–15× baseline).
  • Gluten Substitute: Enables gluten-free bread with dough elasticity matching wheat-based formulations .
  • Edible Films: Extends shelf life by 30–50% in strawberries .
  • Thickening Agent: Effective at 0.1–0.5% in sauces/dairy (viscosity increase: 12–15× baseline).
  • Gluten Substitute: Enables gluten-free bread with dough elasticity matching wheat-based formulations .
  • Edible Films: Extends shelf life by 30–50% in strawberries .

3.Construction Materials

  • Mortar Additive: Reduces shrinkage cracking by 42% at 0.5% dosage
  • Tile Adhesive Enhancer: Boosts bond strength to ≥1.5 MPa after thermal cycling .

4.Cosmetic Formulations

  • Cream Stabilizer: Improves skin-feel scores by 28% in consumer panels (Acta Biotech Sensory Evaluation, 2024).

Qingdao Acta Biotechnology Hypromellose HPMC Specifications

TEST  ITEMS60RT1575RT4000ASE15ASK4MGDE15GDK4MMH-400G
AppearanceWhite to slightly off-white fibrous
or granular powder.
White to slightly off-white fibrous
or granular powder.
White to slightly off-white fibrous
or granular powder.
White to slightly off-white fibrous
or granular powder.
White to slightly off-white fibrous
or granular powder.
White to slightly off-white fibrous
or granular powder.
White to slightly off-white fibrous
or granular powder.
Identification(A) to (C)ConformsConformsConformsConformsConformsConformsConforms
SolubilityConformsConformsConformsConformsConformsConformsConforms
Methoxy (%)28.522.229.3421.2428.422.623.4
Hydroxypropoxy (%)7.88.58.87.648.3810.2
Viscosity(mPa.s)103.3102.414.285140514051404680
pH (1% in Water)6.56.566.126.426.56.87.5
Loss on Drying   (%)3.73.83.21.932.12.63.5
Residue on Ignition (%) /Sulfated ash (%)0.880.820.780.650.920.681.2
Total Aerobic Microbial Count≤10³ cfu/g≤10³ cfu/g≤10³ cfu/g≤10³ cfu/g≤10³ cfu/g≤10³ cfu/g≤10³ cfu/g
Total Combined Yeasts/Molds Count≤10² cfu/g≤10² cfu/g≤10² cfu/g≤10² cfu/g≤10² cfu/g≤10² cfu/g≤10² cfu/g
Arsenic≤3 mg/kg≤3 mg/kg≤3 mg/kg≤3 mg/kg≤3 mg/kg≤3 mg/kg≤3 mg/kg
Lead≤2 mg/kg≤2 mg/kg≤2 mg/kg≤2 mg/kg≤2 mg/kg≤2 mg/kg≤2 mg/kg
Mercury≤1 mg/kg≤1 mg/kg≤1 mg/kg≤1 mg/kg≤1 mg/kg≤1 mg/kg≤1 mg/kg
Cadmium≤1 mg/kg≤1 mg/kg≤1 mg/kg≤1 mg/kg≤1 mg/kg≤1 mg/kg≤1 mg/kg

Representative Product Grades

  • ASE15 (14.28 mPa·s): Optimized for ophthalmic solutions .
  • 75RT4000 (5,140 mPa·s): Intermediate release profiles in matrix tablets .
  • Custom Grades: Available for niche applications .

Market Positioning & Value Proposition

  • Competitive Pricing$2.2–3.0 USD/kg (bulk discounts up to 15% for >10-ton orders).
  • Quality Assurance: Heavy metals 50% below USP limits (e.g., As ≤1.5 ppm vs. USP ≤3 ppm).
  • Regulatory Compliance: Full alignment with USP/NF, EP, JP, and ICH guidelines.
  • Technical Support: PhD-led R&D team offers formulation troubleshooting, substitution ratios, and cGMP packaging.

Why Choose Qingdao Acta Biotechnology?

  • Unmatched Grade Diversity10+ viscosity grades for tailored solutions.
  • Stringent QC: Batch-to-batch consistency (CV ≤2% for viscosity, Internal QC Data, 2023–2025).
  • Global Access: Certifications for 50+ countries with DMF/CEP filings.
  • Innovation Partnerships: Collaborations with MIT, Tsinghua University, and Bayer on novel DDS platforms.

References & Resources

  1. USP-NF Monograph for Hypromellose (Current Edition). Link
  2. FDA GRAS Notice GRN 876 (2020). Link
  3. Clinical Pharmacology Study on HPMC-Based Matrix Tablets (2021). DOI: 10.1002/cpt.2143
  4. Acta Biotech Technical Data Sheets (2025). Download
  5. ISO 17025 Certification for Analytical Labs. View Certificate

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