Dosage Units Uniformity Test
Whether a batch of the drug product meets quality specifications, it is the key that each unit dose must have uniformity active product ingredient (API). The uniformity of the dosage unit can be measured by one of two methods, weight variation or content uniformity. These two methods are applicable to both dosage forms containing a single active ingredient and dosage forms containing two or more active ingredients.
CD Formulation laboratory is cGMP-compliant and equipped with state of the art analytical instruments. We have experienced analysis experts who can work with our formulation and manufacturing team to provide you with dosage units uniformity test services. Our dosage units uniformity test is performed in accordance with pharmacopeia methods and the data that we provide is accurate and reliable, which can help you to conduct appropriate risk assessment of the finished drug.
Application of CU and WV Tests for Dosage Forms
| Dosage Form | Type | Subtype | Dose & Ratio of Drug Substance | |
| ≥ 25mg & ≥ 25% | < 25mg or < 25% | |||
| Tablets | Uncoated | WV | CU | |
| Coated | Film | WV | CU | |
| Others | CU | CU | ||
| Capsules | Hard | WV | CU | |
| Soft | Suspension, emulsion, or gel | CU | CU | |
| Solutions | WV | WV | ||
| Solids in single-unit containers | Single component | WV | WV | |
| Multiple components | Solution freeze-dried in final container | WV | WV | |
| Others | CU | CU | ||
| Suspension, emulsion, or gel for systemic use only, packaged in single-unit containers | CU | CU | ||
| Solutions for inhalation packaged in glass or plastic ampuls and intended for use in nebulizers, and oral solutions packaged in unit-dose containers and into soft capsules | WV | WV | ||
| Inhalations (other than solutions for inhalation packaged in glass or plastic ampuls and intended for use in nebulizers) packaged in premetered dosage units | CU | CU | ||
| Transdermal systems | CU | CU | ||
| Suppositories | CU | CU | ||
| Others | CU | CU | ||
CU: Content Uniformity, WV: Weight Variation
Our Methods of Dosage Units Uniformity Test
| Type | Methods | Requirements |
| Content Uniformity | Raman spectroscopy | not less than 30 units |
| Transmission Raman spectroscopy | ||
| high-performance liquid chromatography | ||
| Near infrared | ||
| Weight Variation | not less than 30 units |
Deliverable
- Data analysis
- Provide full study report
Our Advantages
If you have a requirement about uniformity of dosage units test services, please contact us by phone or email, our colleagues will reply to you within three working days. content uniformity test
References
- Williams R L, Adams W P, Poochikian G, et al. Content Uniformity and Dose Uniformity: Current Approaches, Statistical Analyses, and Presentation of an Alternative Approach, with Special Reference to Oral Inhalation and Nasal Drug Products[J]. Pharmaceutical Research, 2002, 19(4): 359-366.
- Rozet E, Ziemons E, Marini R D, et al. Methodology for the Validation of Analytical Methods Involved in Uniformity of Dosage Units Tests[J]. Analytica Chimica Acta, 2013, 760: 46-52.
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