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Specifications of Hypromellose Acetate Succinate | CAS 71138-97-1
|
Property |
Specification |
|
Grade |
USP42 |
|
Appearance |
Should be white or similar white powder, odorless, tasteless |
|
Viscosity |
Standard: 3 mPa.s, Range: 80%-120% |
|
Acetic acid, succinic acid |
1.0% max |
|
Dry weightlessness |
5.0% max |
|
Residue on ignition |
0.2% max |
|
Heavy metals |
0.001% max |
|
Arsenic salt |
0.0002% max |
|
Methoxy content |
21.0%-25.0% |
|
2-hydroxypropyl content |
5.0%-9.0% |
|
-OCOCH3 content |
7.0%-11.0% |
|
-OCOCH2CH2COOH content |
10.0%-14.0% |
Transport Information of Hypromellose Acetate Succinate | CAS 71138-97-1
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Parameter |
Specification |
|
UN Number |
|
|
Class |
|
|
Packing Group |
|
|
H.S. Code |
3912390000999 |
|
Stability & Reactivity |
Stable |
|
Storage |
Store in a closed, dry, ventilated place |
|
Condition to Avoid |
|
|
Package |
Hypromellose Acetate Succinate | CAS 71138-97-1
Hypromellose Acetate Succinate (HPMCAS) | CAS 71138-97-1 is a cellulose-derived polymer widely utilized in pharmaceutical and nutraceutical applications. Its unique properties make it an essential excipient for drug delivery systems, particularly in enhancing solubility and stability of poorly water-soluble drugs.
Applications of Hypromellose Acetate Succinate | CAS 71138-97-1
1.Pharmaceutical Industry:
- Solid Dispersion Systems: HPMCAS is extensively used in the formulation of amorphous solid dispersions (ASDs), enhancing the bioavailability of poorly water-soluble active pharmaceutical ingredients (APIs).
- Enteric Coatings: The polymer serves as an effective enteric coating agent, protecting APIs from degradation in the acidic environment of the stomach and ensuring targeted drug release in the intestine.
- Controlled Release Systems: Hypromellose Acetate Succinate can be tailored to provide sustained or delayed drug release, optimizing therapeutic outcomes and minimizing dosing frequency.
2.Nutraceuticals:
- Dietary Supplements: HPMCAS is increasingly used in nutraceutical tablets and capsules to improve the absorption and efficacy of active ingredients, particularly for fat-soluble vitamins and herbal extracts.
3.Specialized Applications:
- Solubility Enhancement: For poorly water-soluble drugs, Hypromellose Acetate Succinate forms a molecular dispersion, creating a stable, bioavailable form of the API.
- Stabilization of Drug Formulations: It prevents crystallization of APIs, ensuring consistency and efficacy throughout the product's shelf life.
Benefits of Hypromellose Acetate Succinate | CAS 71138-97-1
1.Enhanced Solubility and Bioavailability:
- Amphiphilic Properties: HPMCAS has both hydrophilic and lipophilic characteristics, improving the solubility of hydrophobic APIs.
- Consistent Drug Absorption: By maintaining APIs in an amorphous state, it enhances their dissolution rate and bioavailability.
2.Targeted Drug Delivery:
- Enteric Protection: Its acid-resistant nature ensures drugs are released only after passing through the stomach, protecting sensitive APIs and reducing gastrointestinal side effects.
- Controlled Release: The polymer's properties can be adjusted to control the rate and site of drug release.
3.Versatility in Formulation:
- Compatibility: Hypromellose Acetate Succinate works with a wide range of APIs and excipients, making it a flexible choice for formulators.
- Adaptable Performance: Available in different grades, it can be customized to meet specific formulation needs.
4.Stability and Shelf Life:
- Thermal and Chemical Stability: HPMCAS provides robust protection against environmental factors, ensuring the integrity of sensitive formulations.
5.Cost-Efficiency:
- Effective Usage: Even at low concentrations, HPMCAS delivers reliable performance, making it a cost-effective excipient for advanced drug formulations.
Precautions and Considerations of Using Hypromellose Acetate Succinate | CAS 71138-97-1
1.Formulation Challenges:
- Solvent Compatibility: HPMCAS requires specific solvents for dissolution during manufacturing, which may affect process design.
- Process Optimization: Achieving the desired drug-polymer interaction often necessitates careful optimization of production parameters.
2.Regulatory Compliance:
- Quality Standards: Consistent quality control is vital to meet regulatory requirements for safety and efficacy.
- Documentation and Testing: Comprehensive documentation of HPMCAS's role in the formulation is essential for regulatory submissions.
Conclusion:
Hypromellose Acetate Succinate | CAS 71138-97-1 is a cornerstone excipient in modern pharmaceutical and nutraceutical formulations. Its ability to improve drug solubility, provide enteric protection, and enable controlled drug delivery makes it indispensable in the development of advanced therapeutics. While it offers numerous benefits, careful consideration of formulation parameters and compliance with regulatory standards are key to unlocking its full potential.

