Page 88 Appendix 13.4 ISPE Good Practice Guide ‘Aesessing the Partoulate Contsinment Performance of Phatmaceutieal Equipment Attachment D: Example Material Certificate of Analysis Description: Monohydrate, Crystalline, 325 mesh. ‘Chemical Analysis Acilty or alkalinity Clarity and color @ 400 nm Heavy metals, mala Loss on arying, % Protein and light-absorbing impurities at 210 to 220 nm at 270 to 300 nm Residue on ignition, % Specific rotation Water, % Microbiological Standards ‘Total aerobic microbial count Escherichia coli ‘Total combined molds and yeasts count Staphylococcus aureus Pseudomonas aeruginosa Salmonella species Powder Fineness (Cumulative) ‘On USS #200 (75 ym) ‘On USS #325 (45 ym) ‘On USS #400 (37 4m) Physical Characteristics Density ‘Appearance Flavor and odor Storage Conditions Allergen Classi Typical Specification orm 04 mi of 0.1 N NAOH (maximum) oor 0.04 (maximum) Less than 5.0 5.0 (mnaximum) 02 0.5 (maximum) 0.05 025 (maximum) 001 0.07 (maximum) 0.02 0.1 (maximum) +55,0" to 155.3" 1564" t0 155.9" 481052 451055 Typical Specification Less than 40efulg 100 cfg (maximum) Negative Negative Loss than 10 cfulg 50 efulg (maximum) Negative Negative Negative Negative Negative Negative Typical Specification 0.0% 101.0% 4.0% (maximum) 2.0% 10 8.0% 10.0% (maximum) 15% t0 25% Not applicable Bulk 0,44 glmL; Tapped 0.72 glmL. White, crystalline powder Slightly sweet Protect from moisture and excessive heat. Contains lactose, does not contain milk or whey proteins. For individual use only. © Copyright ISPE 2012. All rights reserved.