Scribd
Upload
158 views2 pages

Paracetamol Dissolution Test

The pH of the phosphate buffer for the paracetamol dissolution test is 5.8, prepared by dissolving 6.8 g of monobasic potassium phosphate in purified water and adjusting the pH as necessary. The dissolution test involves using USP Apparatus 1 or 2, maintaining the temperature at 37 ± 0.5°C, and analyzing samples withdrawn at specified time points. Acceptance criteria require 80% of the paracetamol to be dissolved within 30 minutes for immediate-release tablets.

Uploaded by

Muhammad Naqi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
158 views2 pages

Paracetamol Dissolution Test

The pH of the phosphate buffer for the paracetamol dissolution test is 5.8, prepared by dissolving 6.8 g of monobasic potassium phosphate in purified water and adjusting the pH as necessary. The dissolution test involves using USP Apparatus 1 or 2, maintaining the temperature at 37 ± 0.5°C, and analyzing samples withdrawn at specified time points. Acceptance criteria require 80% of the paracetamol to be dissolved within 30 minutes for immediate-release tablets.

Uploaded by

Muhammad Naqi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 2

what is the pH of phosphate buffer for paracetamol dissolution test and how we prepare

the phosphate buffer for paracetamol dissolution test?

For the paracetamol (acetaminophen) dissolution test, the phosphate buffer specified in
pharmacopeial methods (such as USP, BP, or Ph. Eur.) typically has a pH of 5.8.

Preparation of Phosphate Buffer (pH 5.8) for Paracetamol Dissolution Test


Reagents Required:
- Monobasic potassium phosphate (KH₂PO₄)
- Sodium hydroxide (NaOH) or Hydrochloric acid (HCl) (for pH adjustment)
- Purified water

Procedure:
1. Dissolve 6.8 g of KH₂PO₄
in about 900 mL of purified water.
2. Adjust the pH to 5.8 using either:
- 1 M NaOH(if the pH is too low)
- 1 M HCl (if the pH is too high)
3. Dilute to 1000 mL with purified water.
4. Verify the pH using a calibrated pH meter.

Key Notes:
- The USP Monograph for Paracetamol typically recommends pH 5.8 phosphate buffer as the
dissolution medium.
- The buffer should be degassed before use to prevent bubble formation during the dissolution
test.
- The temperature should be maintained at 37 ± 0.5°C during testing.

how we perform dissolution test for paracetamol?

The dissolution test for paracetamol (acetaminophen) is performed according to pharmacopeial


standards (USP, BP, Ph. Eur.). Below is a step-by-step procedure based on USP-NF
guidelines.

---

Dissolution Test Conditions for Paracetamol Tablets


Apparatus:
- USP Apparatus 1 (Basket)or Apparatus 2 (Paddle)
- Commonly, Apparatus 2 (Paddle) is used at 50 rpm for immediate-release tablets.

Dissolution Medium:
- 900 mL of phosphate buffer (pH 5.8) (prepared as previously described).
- Temperature:Maintained at 37 ± 0.5°C.

Test Procedure:
1. Pre-warm the dissolution medium to 37 ± 0.5°C and degas (to avoid bubble formation).
2. Place one tablet in each vessel (typically 6 vessels for a full test).
3. Operate the paddle at 50 rpm (or basket at 100 rpm, if specified).
4. Withdraw samples at specified time points (e.g., 5, 10, 15, 30, and 45 minutes).
- Use a syringe with a filter (0.45 μm or 0.8 μm pore size)to avoid undissolved particles.
5. Analyze the samples using UV spectrophotometry(at 243 nm for paracetamol) or HPLC.
6. Calculate the percentage dissolved by comparing against a standard solution.

Acceptance Criteria (USP for Immediate-Release Tablets):


- Q = 80% dissolved in 30 minutes(for most monographs).

---

Key Notes:
- For extended-release tablets, a different rpm (e.g., 100 rpm) and multiple time points (1, 2, 4, 8
hours) may be used.
- Validation(sink condition, stability, specificity) should be confirmed.
- Apparatus calibration(e.g., vibration, centering) is critical for reproducibility.

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy