医薬品原薬中の類縁物質・微量不純物

API製造時に発生する不純物です。
ジェネリック薬を新たに開発する際、先発品と類縁物質（不純物）の上限規定も同等にする必要になります。その測定・管理に必要な標準物質になります。

当品目は、弊社にて日本向けの代理店を行っいる Clearsynth Lab より供給させていただきます。
当社は、医薬品開発、あるいは品質管理に必要な各種標準物質の専門メーカーです。

Fluvastatin-3-keto-5-Hydroxy
CAS No.:	-
Formula:	C24H25FN04.Na
Controlled Substance:	False
Details:	Antilipemic

Fluvastatin-N-Ethyl Analogue
CAS No.:	-
Formula:	C23H23FN04
Controlled Substance:	False
Details:	Antilipemic

Formyl-Ciprofloxacin
CAS No.:	93594-39-9 85721-33-1
Formula:	C18H18FN3O4
Controlled Substance:	False
Details:	Antibacterial

Gestodene methyl analogue: 17alpha-(1-Propyn-1-yl)-17â-hydroxy-18-methyl-4,15-estradien-3-one
CAS No.:	60282-87-3
Formula:	C22H28O2
Controlled Substance:	False
Details:	Progestogen. In combination with estrogen as oral contraceptive.

Gliclazide analogue: N-[[(Hexahydrocyclopenta [c]pyrrol-2(1H)-yl)amino]carbonyl]-2-methyl benzenesulfonamide
CAS No.:	21187-98-4
Formula:	C15H21N3O3S
Controlled Substance:	False
Details:	Antidiabetic.

Irinotecan 4-Methyl Analogue
CAS No.:	97682-44-5
Formula:	C34H40N4O6
Controlled Substance:	False
Details:	Antineoplastic.

Isopropyl Esmolol acid
CAS No.:	81147-92-4
Formula:	C18H30N2O3
Controlled Substance:	False
Details:	Antiarrhythmic

Itraconazole-5-methyl-2-isopentane
CAS No.:	84625-61-6
Formula:	C37H42Cl2N8O4
Controlled Substance:	False
Details:	Antifungal.

Keto Itraconazole
CAS No.:	84625-61-6
Formula:	C35H36Cl2N8O5
Controlled Substance:	False
Details:	Antifungal.

Ketoconazole Impurity A
CAS No.:	65277-42-1
Formula:	C26H26Cl2N4O4
Controlled Substance:	False
Details:	Antifungal

Ketoconazole Impurity B
CAS No.:	65277-42-1
Formula:	C38H42Cl2N6O6
Controlled Substance:	False
Details:	Antifungal

Ketoconazole Impurity C
CAS No.:	65277-42-1
Formula:	C26H28Cl2N4O4
Controlled Substance:	False
Details:	Antifungal