Disintegration Test

The disintegration test is to evaluate the ability of a sample to break into smaller particles under standard conditions. The test is usually performed on tablets, capsules, and enteric-coated tablets, and it provides critical safety data on the bioavailability of drugs in vivo without the use of in vivo methods. Therefore, disintegration testing is very important for oral formulations.

CD Formulation can provide analytical services for a variety of dosage forms. Our laboratory is cGMP-compliant and equipped with state of the art analytical instruments. Our scientists conduct proven analytical process development and validation services and work as an integrated team to provide solutions that make your project a success. At CD Formulation ，Our disintegration testing is performed under specified conditions according to specific applicable pharmacopoeial standards. In addition, all our standard solutions and reagents for disintegration testing comply with the regulations of the Pharmacopoeia.

We Can Provide Disintegration Testing According the Following Pharmacopoeias

• European Pharmacopoeia (Ph. Eur.)
• United States Pharmacopoeia (USP)
• Japanese Pharmacopoeia (JP)
• Chinese Pharmacopoeia (ChP)

Disintegration Testing Affected Factors

• Binders
• Lubricants
• Surfactants
• Hardness

Our Methods for Disintegration Test

Deliverable

• Data analysis
• Provide full study report

Our Advantages

If you have a requirement about disintegration test services, please contact us by phone or email, our colleagues will reply to you within three working days.

References

1. Al-Gousous J, Langguth P. Oral Solid Dosage Form Disintegration Testing-The Forgotten Test[J]. Journal of Pharmaceutical Sciences, 2015, 104(9): 2664-2675.
2. Brniak W, Jachowicz R, Pelka P. The Practical Approach to the Evaluation of Methods used to Determine the Disintegration Time of Orally Disintegrating Tablets (ODTs)[J]. Saudi Pharmaceutical Journal, 2015, 23(4): 437-443.
3. Silva D A, Webster G K, Bou-Chacra N, et al. The Significance of Disintegration Testing in Pharmaceutical Development[J]. Dissolut. Technol, 2018, 25: 30-38.