Blend uniformity analysis

Technical Report No. 25 Blend Uniformity Analysis Validation and In-Process Testing. J Pharm Sci Technol 1997 Supplement, 51(S3). 

Food Drug Administration, Center for Drug Evaluation and Research, Draft Guidance for Industry, August 1999, ANDAs Blend Uniformity Analysis. 

Blend uniformity analysis validation and in-process testing. Technical Report No. 25. J. Pharmaceu. Sci. Technol. 51(suppl) 53, 1997. 

Blend uniformity analysis Validation and in-process testing, technical report no. 25. PDA J Pharm Sci Tech (suppl.) 51 (1997). 

Blend Uniformity Analysis Validation and In-Process Testing 25 1997... 

Draft Guidance for Industry ANDAs Blend Uniformity Analysis. This guidance provides recommendations on when and how blend uniformity analysis should be performed. The recommendations apply to original ANDAs and supplemental ANDAs for formulation and process changes. The Federal Register notice for this draft is also available. 

PhRMA Statistics Working Group. Comments on ANDAs Blend Uniformity Analysis—Draft Guidance 1999. 

Blend uniformity analysis using stream sampling and near infrared spectroscopy. AAPS Pharm. Sci. Tech. 2002, 3 (3), 81. 

In August 1999, the FDA published a draft guidance document ANDAs Blend Uniformity Analysis (66) to address industry concerns regarding the inconsistent... 

Once a sample larger than 3x is collected, a question remains as to what to do with that sample prior to assay. The withdrawn draft guidance ANDAs Blend Uniformity Analysis recommends sample sizes l-3x to be collected, but that the sample weight tested (assayed) should be equivalent to the dosage used. Unfortunately any subdivision of the sample is likely to induce either potency losses or segregation,. so the logistics of how to subdivide such a sample remains a challenge. 

The proper selection of sampling techniques or sampling devices affects the calculation value of the relative standard deviation of a powder mixture, the indication of homogeneity. With the use of conventional side slit thief for sampling for blend uniformity analysis, discrepancy between the two values (blend uniformity versus content uniformity) can be determined. In the manufacture of some tablets, the relative standard deviation of the blend uniformity of a lot of bulk powder mix was found to be unacceptable and should have been rejected, whereas the tablets prepared with that powder blend unexpectedly met the content uniformity test. The noncorrelated relative standard deviation values of these two tests required clarification. 

M. Popo, S. Romero-Torres, C. Conde, and R. J. Romanach, Following the Progress of a Pharmaceutical Mixing Study via Near-Infrared Spectroscopy Blend Uniformity Analysis Using Stream Sampling and Near Infrared Spectroscopy, AAPS PharmSciTech, 3, 1 (2002). 

Guidance to Industry Blend Uniformity Analysis FDA CDER US Oct 1999. 

Li, W., Johnson, M., Bruce, R., Ulrich, S., Rasmussen, H. and Worosila, G. Mass-balanced blend uniformity analysis of pharmaceutical powders by at-line near-infrared spectroscopy with a fiberoptic probe. Int. J. Pharm. 326(1-2) 182-185, 2006. 

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