📊 FDA Blend Uniformity (10-Point Thief Sampling, Active Ingredient RSD <3.0%, cGMP)

Pharmaceutical Blend Uniformity & RSD Calculator

Calculate Relative Standard Deviation ($RSD = rac{s}{ar{x}} imes 100 < 3.0%$) and active pharmaceutical ingredient (API) assay recovery across 10-point core sample thief locations under FDA cGMP Guidance for Industry (Andreason / Stratified Sampling): validate powder blend homogeneity, eliminate batch recalls, and validation profits.

1. Project & Operating Inputs

Annual Validation Batches (Batch Count e.g. 50 Commercial Blend Runs)

Active Target Assay (Percent e.g. 100.0% Nominal Active Ingredient)

Annual Customer Blend Sampling & HPLC Testing Agreement ($ / Yr)

Sanitary Sample Thieves, HPLC Column Analysis, Certified QA Scientist ($)

2. Financial Breakdown & Yield

FDA CGMP BLEND UNIFORMITY

Turnkey Blend Uniformity Validation & Lab Profit

Pharma Quality Assurance Consulting Margin

0.0%

Gross Revenue / Bill

Total Project CapEx

Operating / Direct Cost