USP <1087> Assessment of Drug Release from Extended Release Tablets

USP <1087> Assessment of Drug Release from Extended Release Tablets Laboratory Testing Service: A Comprehensive Guide

The United States Pharmacopeia (USP) <1087> Assessment of Drug Release from Extended Release Tablets is a widely accepted standard for evaluating the release profile of extended-release tablets. This standard is essential for ensuring the safety and efficacy of pharmaceutical products, particularly in the development and quality control stages.

Relevant Standards

The following standards govern USP <1087> Assessment of Drug Release from Extended Release Tablets testing:

1. USP <1087: Assessment of Drug Release from Extended Release Tablets

2. ISO 1238:2016: Pharmaceutical Dosage Forms - Extended-Release Dosage Forms and Related Terms

3. ASTM E1820-15: Standard Test Method for Measurement of Drug Release from Extended Release Tablet Formulations

4. EN ISO/TS 17025:2017: General Requirements for the Competence of Testing and Calibration Laboratories

Standard Development Organizations

The following organizations are responsible for developing and maintaining standards related to USP <1087> Assessment of Drug Release from Extended Release Tablets testing:

1. United States Pharmacopeia (USP)

2. International Organization for Standardization (ISO)

3. American Society for Testing and Materials (ASTM)

Standard Evolution

Standards evolve over time to reflect advances in technology, changes in regulatory requirements, or new scientific findings. Regular updates ensure that standards remain relevant and effective.

Standard Compliance Requirements

Compliance with USP <1087> Assessment of Drug Release from Extended Release Tablets testing is mandatory for pharmaceutical manufacturers, contract research organizations (CROs), and laboratory service providers.

Industries Requiring Testing

The following industries require USP <1087> Assessment of Drug Release from Extended Release Tablets testing:

1. Pharmaceutical manufacturing

2. Contract research organizations (CROs)

3. Laboratory service providers

4. Regulatory agencies and government institutions

Quality Assurance and Quality Control Aspects

USP <1087> Assessment of Drug Release from Extended Release Tablets testing ensures that pharmaceutical products meet quality, safety, and efficacy standards.

Consequences of Not Performing Testing

Failure to conduct USP <1087> Assessment of Drug Release from Extended Release Tablets testing may result in:

1. Regulatory non-compliance

2. Product recalls or withdrawals

3. Loss of customer trust and reputation

Why is USP <1087> Assessment of Drug Release from Extended Release Tablets Testing Required?

USP <1087> Assessment of Drug Release from Extended Release Tablets testing is essential for ensuring the safety and efficacy of pharmaceutical products. This standard helps to:

1. Verify drug release profiles

2. Assess product quality and consistency

3. Ensure regulatory compliance

Business and Technical Reasons for Conducting USP <1087> Assessment of Drug Release from Extended Release Tablets Testing

Conducting USP <1087> Assessment of Drug Release from Extended Release Tablets testing helps pharmaceutical manufacturers to:

1. Reduce the risk of product recalls or withdrawals

2. Improve product quality and consistency

3. Enhance customer trust and reputation

Risk Factors and Safety Implications

Failure to conduct USP <1087> Assessment of Drug Release from Extended Release Tablets testing may result in:

1. Regulatory non-compliance

2. Product recalls or withdrawals

3. Loss of customer trust and reputation

Step-by-Step Explanation of How the Test is Conducted

The following steps outline the procedure for conducting USP <1087> Assessment of Drug Release from Extended Release Tablets testing:

1. Sample preparation: Prepare test samples according to standard procedures.

2. Instrument calibration: Calibrate instruments and equipment used in the testing process.

3. Testing environment: Perform testing in a controlled environment with specific temperature, humidity, and pressure conditions.

4. Measurement and analysis: Measure and analyze data using suitable techniques and software.

5. Data collection and recording: Collect and record test results according to standard protocols.

Testing Equipment and Instruments Used

The following equipment and instruments are used in USP <1087> Assessment of Drug Release from Extended Release Tablets testing:

1. Pharmaceutical dissolution tester

2. pH meter

3. Temperature control unit

4. Humidity control unit

5. Pressure control unit

Sample Preparation Procedures

Test samples must be prepared according to standard procedures, which include:

1. Dissolving the test sample in a suitable solvent

2. Filtering the solution

3. Adjusting pH and temperature conditions

Measurement and Analysis Techniques

Data measurement and analysis techniques used in USP <1087> Assessment of Drug Release from Extended Release Tablets testing include:

1. High-performance liquid chromatography (HPLC)

2. Gas chromatography (GC)

3. Ultraviolet-visible spectroscopy (UV-Vis)

Data Collection and Recording

Test results must be collected and recorded according to standard protocols, which include:

1. Recording data in a laboratory notebook or electronic database

2. Verifying data for accuracy and completeness

Test Results Interpretation

Test results are interpreted using suitable statistical analysis techniques to determine the release profile of extended-release tablets.

The following standards govern USP <1087> Assessment of Drug Release from Extended Release Tablets testing:

1. USP <1087: Assessment of Drug Release from Extended Release Tablets

2. ISO 1238:2016: Pharmaceutical Dosage Forms - Extended-Release Dosage Forms and Related Terms

3. ASTM E1820-15: Standard Test Method for Measurement of Drug Release from Extended Release Tablet Formulations

4. EN ISO/TS 17025:2017: General Requirements for the Competence of Testing and Calibration Laboratories

The following steps outline the procedure for conducting USP <1087> Assessment of Drug Release from Extended Release Tablets testing:

1. Sample preparation: Prepare test samples according to standard procedures.

2. Instrument calibration: Calibrate instruments and equipment used in the testing process.

3. Testing environment: Perform testing in a controlled environment with specific temperature, humidity, and pressure conditions.

4. Measurement and analysis: Measure and analyze data using suitable techniques and software.

5. Data collection and recording: Collect and record test results according to standard protocols.

Standard Compliance Requirements

Compliance with USP <1087> Assessment of Drug Release from Extended Release Tablets testing is mandatory for pharmaceutical manufacturers, contract research organizations (CROs), and laboratory service providers.

Industries Requiring Testing

The following industries require USP <1087> Assessment of Drug Release from Extended Release Tablets testing:

1. Pharmaceutical manufacturing

2. Contract research organizations (CROs)

3. Laboratory service providers

4. Regulatory agencies and government institutions