ICH Q3D 元素杂质指南(4) 附录2 已建立的元素杂质PDE

更新时间:2023-05-11 17:55:00 阅读：评论：0

Appendix 2: Established PDEs for Elemental Impurities

附录2：已建立的元素杂质PDE

Table A.2.1: Permitted Daily Exposures for Elemental Impurities

表A.2.1: 元素杂质允许日暴露量

Element		Class	Oral PDE μg/day	Parenteral PDE μg/day	Inhalation PDE, μg/day
元素		分类	口服PDE	注射PDE	吸入PDE
Cd	镉	1	5	2	2
Pb	铅	1	5	5	5
As	砷	1	15	15	2
Hg	汞	1	30	3	1
Co	钴	2A	50	5	3
V	钒	2A	100	10	1
Ni	镍	2A	200	20	5
Tl	铊	2B	8	8	8
Au	金	2B	100	100	1
Pd	钯	2B	100	10	1
Ir	铱	2B	100	10	1
Os	锇	2B	100	10	1
Rh	铑	2B	100	10	1
Ru	铷	2B	100	10	1
Se	硒	2B	150	80	130
Ag	银	2B	150	10	7
Pt	铂	2B	100	10	1
Li	锂	3	550	250	25
Sb	锑	3	1200	90	20
Ba	钡	3	1400	700	300
Mo	钼	3	3000	1500	10
Cu	铜	3	3000	300	30
Sn	锡	3	6000	600	60
Cr	铬	3	11000	1100	3

1 PDEs reported in this table (μg/day) have been established on the basis of safety data described in the monographs in Appendix 3, and apply to new drug products. The PDEs in the monographs are not rounded. For practical purpos the PDEs in this table have been rounded to 1 or 2 significant figures. PDEs less than 10 have 1 significant figure and are rounded to the nearest unit. PDEs greater than 10 are rounded to 1 or 2 significant figures as appropriate. The principles applied to rounding in this table may be applied to PDEs derived for other routes of administration. 本表中报告的PDE（μg/day）是基于附录3各论中所述的安全数据建立的，适用于新药。各论中的PDE未进行修约。为了实用的目的，本表中的PDE已修约至1位或2位有效数字。PDE小于10的修约至最近的单位，保留1位有效数字，适当时，大于10的修约为1位或2位有效数字。本表中的修约原则可以用于其它给药途径的PDE计算。

2 Classification as defined in Section 4. 分类原则参见第4部分定义。

Table A.2.2: Permitted Concentrations of Elemental Impurities for Option 1

表A.2.2:方法1中元素杂质的允许浓度

The values prented in this table reprent permitted concentrations in micrograms per gram for elemental impurities in drug products, drug substances and excipients. The concentration limits are intended to be ud when Option 1 is lected to asss the elemental impurity content in drug products with daily dos of not more than 10 grams per day. The numbers in this table are bad on Table A.2.1.

本表中列出的值表示了药品、原料药和辅料中元素杂质的允许浓度，单位为mg/g。当选择使用方法1时，可以使用这些浓度来评估日剂量不超过10g/天的药品中含有的元素杂质。本表中的数值是基于表A.2.1的。

Element		Class	Oral concentration μg/g	Parenteral concentration μg/g	Inhalation concentration, μg/g
元素		分类	口服浓度	注射浓度	吸入浓度
Cd	镉	1	0.5	0.2	0.2
Pb	铅	1	0.5	0.5	0.5
As	砷	1	1.5	1.5	0.2
Hg	汞	1	3	0.3	0.1
Co	钴	2A	5	0.5	0.3
V	钒	2A	10	1	0.1
Ni	镍	2A	20	2	0.5
Tl	铊	2B	0.8	0.8	0.8
Au	金	2B	10	10	0.1
Pd	钯	2B	10	1	0.1
Ir	铱	2B	10	1	0.1
Os	锇	2B	10	1	0.1
Rh	铑	2B	10	1	0.1
Ru	铷	2B	10	1	0.1
Se	硒	2B	15	8	13
Ag	银	2B	15	1	0.7
Pt	铂	2B	10	1	0.1
Li	锂	3	55	25	2.5
Sb	锑	3	120	9	2
Ba	钡	3	140	70	30
Mo	钼	3	300	150	1
Cu	铜	3	300	30	3
Sn	锡	3	600	60	6
Cr	铬	3	1100	110	0.3

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