25.5. Microbiol Changes 703 “Table 25-7. Recommended Acceptance Criteria for the Microbiological Quality of Herbal Medicinal Products for Oral Use (Ph, Eur 5.1.8 USP (2023), PGA MierobialAetrbues of Nonstrde Pharmaceutical Product) Spend Wiooranions Apne ition (CFU/g oF mt rapa the sample wsight i oat tn bracts) amc. wc Eneerobacteria Acceprance Acceprance Bile-tolerane and other Medicinal Criterion (CFU/g, Criterion (CFU/g gram-negative Escherichia gram-negative Catagory Product orml) cormt) bacteria coh bacteria Salmonella a Herbal medicinal Ph. Exe 10 Ph. Bs 10 Ph Bors md, Ph furs 10? Ph Borsmd, Ph Eur absence product forthe (oe acer das acept asa) prepercion cf count: count 500,000) {nfisons aad 50,000,000) ecoctions wing yp. a usr: 10 usr 0? UsPsabsence USP USP sbsence baling wae (op cow) we? Bo! Pena io Pend IP abvence (sample we (Gomple wt nd) nd) > eral mesial Ph Burs 10" (max. PR Bas 10" (ma Ph Bars 10? Ph Bi Puan Ph Basaboee products were accept. count exept count: absence (I 8 (OS germ) Yhemetiog of $0,000) 500) oem) rromag (C8 usr-nd seen seen usend — Usead useing eee Pend, Ind Pend, rad nd ec the evel of ‘organisms 9 elo thane ated for this category é Hebilmeiicnl — PLAw10" (uk AL BIO" (mmx PATO" PA Bar Pu Eurond Ph Bursabvence products where accept count cep. conn abnence (1 8 (5 gormt ‘hemetiod of $00,000) 0.000) cml) rosea. Ut: 10! Use: 102 use 10 USP absence USP nd USP. abence ‘entation i Ge eh dow sre F ‘ 2 ; vee ‘ethane oF mero mmo end absence 10° absence (ample we (ample wena) reeset ‘would not reduce Load the love! of crysis silently to reach the rteria ruled ander B ‘max, accept count = maximum acepabe count hha. = not define (When an accepeance criterion for micobilogal quay is pecbed is erpretd sown: +10! CFU: masimum accepable count = 20 +10 CFU: maximum seoepable count = 200 +10? CFU; maximum aeceprable count = 2000, ane so forth “Table 25.8 Acceptance Criteria fr Microbiological Quality of Nonserile Substances for Pharmaceutical Use (Ph Eur. 5.1.4, USP (1111), PG—Microbial ‘Acrbutes of Nonacere Pharmaceutical Products) ‘TAME (CFU/g or ml) TYMC (CFU/g or mt) sutmances for parmaccutieal we 10 1 (GAMC= tol aerobic microbial count, TYMC = oul combined yeas/moks count) The sccepance entra presented are interpreted follow: 10! CRU: maximum accepae count 20 108 CFU: maximum crepe count 200 10) CFU: maximum acceptable count; 2,000, et.