How do I check my uniformity content?
How do I check my uniformity content?
Analytical methods to assess content uniformity The most common method for assessing content uniformity in OSDs is high-performance liquid chromatography (HPLC), observes Andrews. “HPLC has the advantages of flexibility, sensitivity, and ubiquity, and many analytical chemists are trained to use HPLC methods,” he says.
How do I access European Pharmacopoeia online?
Register for access
- On the Pharmeuropa homepage, click on “Register” on the right of the menu bar.
- Enter the e-mail address that will serve as your login, fill in the captcha, then click on “Next”.
- Complete the registration and follow the instructions in the e-mail confirmation.
What is the USP limit for content uniformity?
The USP acceptance criteria for content uniformity states that the relative standard deviation (RSD) of a sample of 30 units should not exceed 7.8%.
When content uniformity test is applicable?
Content Uniformity is the default test and may be applied in all cases. The test for Weight Variation is applicable for dosage forms specified as W1, W2, W3, and W4. The requirements for dosage uniformity are met if the acceptance value of the first 10 dosage units is less than or equal to L1%.
Why content uniformity test is important?
Content uniformity is one in a series of tests in a therapeutic product specification that assesses the quality of a batch. Testing for content uniformity helps ensure that the strength of a therapeutic product remains within specified acceptance limits.
How many tablets are required for content uniformity test?
The test for uniformity of weight is performed by weighing individually 20 tablets randomly selected from a tablet batch and determining their individual weights.
How do I access European Pharmacopoeia?
To gain access, you must have an EDQM account, which you can enter using your e-mail address and associated password. In the case of the European Pharmacopoeia electronic version, your account must also be associated with a subscription key (i.e. EPID code).
Is Ph Eur and EP same?
Answer: The official abbreviation is ‘Ph. Eur. ‘ and not ‘EP’ (which is registered for the European Parliament).
How many tables are required for content uniformity test?
Two Acceptance Limit Tables based on a 50% confidence level for sample sizes of 10 & 30. Sampling Plan 2 tables with a 90% confidence level are provided for three sampling plans: 20×3, 20×7, and 40×3 (# locations x # tested per location).
What is NMT limit?
The proposed limit of NMT 20 ppm for heavy metals is based upon a general limit applied to pharmacopeial items. Testing is based Page 6 6 upon the USP Heavy Metals Test (<231> Method II). Moisture. MK is not hygroscopic (<0.5% water uptake at 90% RH). There are also no known hydrate forms of MK.
How many tablet are required for content uniformity test?
Uncoated and FilmCoated Tablets— Weigh accurately 10 tablets individually. From the result of the Assay , obtained as directed in the individual monograph, calculate the content of active ingredient in each of the 10 tablets, assuming homogeneous distribution of the active ingredient.
What is the difference between assay and content uniformity?
The main difference between content uniformity and assay is that content uniformity is a test in which evaluation units are done individually whereas assay is a test in which multiple units are done simultaneously. Furthermore, the evaluation procedure of content uniformity tests is the same for all units.
