l*u
发帖数: 2090 | 1 相对于 医药的API
用于香料 化妆品 食品的化学成分的管理条例是不是宽松很多？
比如纯度 这些
外行拜谢 |
s*****l
发帖数: 1844 | 2 Cosmetics and food regulations are much looser than drug API. Drug API is
probably the toughest among everything.
Give you an ironic example, some literature reported that a food additive
could be a potential genotoxic compound; therefore, this compound will have
to be controlled at ppm (often single digit ppm depending on daily drug
dosage) level in drug API, however, the compound is used at hundred mg level
as food additives, and what's more, this compound is widely existent in
bread, beer, cheese etc, you name it. Then you know why drugs are so
expensive... |
w******y
发帖数: 8040 | 3 what is that food additive?
have
level
【在 s*****l 的大作中提到】
: Cosmetics and food regulations are much looser than drug API. Drug API is
: probably the toughest among everything.
: Give you an ironic example, some literature reported that a food additive
: could be a potential genotoxic compound; therefore, this compound will have
: to be controlled at ppm (often single digit ppm depending on daily drug
: dosage) level in drug API, however, the compound is used at hundred mg level
: as food additives, and what's more, this compound is widely existent in
: bread, beer, cheese etc, you name it. Then you know why drugs are so
: expensive...
|
E***n
发帖数: 308 | 4 sounds like HCHO
【在 w******y 的大作中提到】
: what is that food additive?
:
: have
: level
|
L*******a
发帖数: 824 | 5 Hundred mg level of formaldehyde???
【在 E***n 的大作中提到】
: sounds like HCHO
|
px
发帖数: 853 | 6 Were you talking about Acetamide? It is regulated in Europe now.
have
level
【在 s*****l 的大作中提到】
: Cosmetics and food regulations are much looser than drug API. Drug API is
: probably the toughest among everything.
: Give you an ironic example, some literature reported that a food additive
: could be a potential genotoxic compound; therefore, this compound will have
: to be controlled at ppm (often single digit ppm depending on daily drug
: dosage) level in drug API, however, the compound is used at hundred mg level
: as food additives, and what's more, this compound is widely existent in
: bread, beer, cheese etc, you name it. Then you know why drugs are so
: expensive...
|
s*****l
发帖数: 1844 | 7 Nope. Not much discussion about acetamide as it has to be controlled at very
low ppm level. Please do not guess what the compound is any more. My point
is that the regulation for drug is at least among the most strict, if not
the most strict, of all substances...
【在 px 的大作中提到】
: Were you talking about Acetamide? It is regulated in Europe now.
:
: have
: level
|
a*********7
发帖数: 180 | 8 I agree. pharmaceuticals should have complied the most stringent limits
among all others (i.e food, cosmetics, natural health product, etc). i.e ICH
limits,,and EMEA and FDA have guidances for genotoxic impurities... |
t**n
发帖数: 4365 | 9 药物GTI上限致癌概率1/10E5
食品GTI上限致癌概率1/10E6
ICH
【在 a*********7 的大作中提到】
: I agree. pharmaceuticals should have complied the most stringent limits
: among all others (i.e food, cosmetics, natural health product, etc). i.e ICH
: limits,,and EMEA and FDA have guidances for genotoxic impurities...
|
a****e
发帖数: 606 | 10 what is GTI?
【在 t**n 的大作中提到】
: 药物GTI上限致癌概率1/10E5
: 食品GTI上限致癌概率1/10E6
:
: ICH
|
|
|
l*u
发帖数: 2090 | 11 同问
【在 a****e 的大作中提到】
: what is GTI?
|
t**n
发帖数: 4365 | 12 genotoxic impurity 啊 。。。
【在 a****e 的大作中提到】
: what is GTI?
|
a****e
发帖数: 606 | 13 这是哪里的标准?fda那个draft guidance有么?
【在 t**n 的大作中提到】
: genotoxic impurity 啊 。。。
|
t**n
发帖数: 4365 | 14 应该有。不然EMEA那个肯定有。我说的是risk，不是标准。药物GTI控制TTC就是从食品
工业引用过来的。
【在 a****e 的大作中提到】
: 这是哪里的标准?fda那个draft guidance有么?
|
t**n
发帖数: 4365 | 15 应该有。不然EMEA那个肯定有。我说的是risk，不是标准。药物GTI控制TTC就是从食品
工业引用过来的。
【在 a****e 的大作中提到】
: 这是哪里的标准?fda那个draft guidance有么?
|
a****e
发帖数: 606 | 16 学习了。木有研究过那两guidance，一般我就拿来套套公式。
【在 t**n 的大作中提到】
: 应该有。不然EMEA那个肯定有。我说的是risk，不是标准。药物GTI控制TTC就是从食品
: 工业引用过来的。
|
