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.

Dosage Units Uniformity Test

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

Dosage Units Uniformity Test

How to Contact Us?

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

  1. 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.
  2. 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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Please note: Our products and services can only be used for research purposes. Do not use in diagnostic or therapeutic procedures!
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