有关物质方法确认方案

METHOD VERIFICATION PROTOCOL FOR CHROMATOGRAPHIC PURITY OF CYTARABINE 阿糖胞苷有关物质检查方法确认方案

Contents

目录

一、In troduct ion (3)

二、Scope (3)

三、Resp on sibility (3)

四、Defin iti ons (4)

五、Project (6)

六、Refere nces (27)

In troduct ion

简介

## is in the process of developing Cytarabine Injection, a liquid product for

pare nteral adm ini strati on, for ##. Cytarab ine is a chemotherapy age nt with a molecular weight of 243.2. The API from Zhejia ng Hisun Pharmaceutical Co. Ltd, which is approved

by FDA, is used for Cytarab ine

Injection by Lummy.The Chromatographic purity method for Cytarab ine is

the method in the current USP34. The HPLC method for Chromatographic

purity test of Cytarabine is a quantitative method. The method will be verified according to USP<1226>, including system suitability, specificity,

LOD, LOQ, precisi on, soluti on stability and mobile phase stability .

阿糖胞苷注射液是一种临床用液体产品，##药业为##药业研发该品种。阿糖胞苷

是一种化学药，分子量为243.2。莱美研发阿糖胞苷注射液所用原料药来源于浙江海正药业，是获得了FDA认证的原料药。阿糖胞苷色谱纯度检测方法来自现行USP34, 色谱纯度检查方法，是定量检测方法。依照USP<1226>，本次确认内容包括系统适

用性，专属性，检测限，定量限、精密度、溶液稳定性和流动相稳定性。

Scope

范围

This protocol applies to the verification for chromatographic purity of cytarab ine.

该方案适用于阿糖胞苷色谱纯度的方法确认。

Resp on sibility

职责

四、Defin iti ons

定义

1 Limit of Detectio n (LOD)

检测限(LOD )

The limit of detecti on of an in dividual an alytical procedure is the lowest

amount of an alyte in a sample which can be detected but not n ecessarily qua ntitated as

an exact value.

分析规程中的检测限是指样品中的被分析物在该分析方法中能被检测，但不需要准确定量

的最低浓度。

The detection limit is determined by analyzing samples with known

concentrations of analyte and by establishing the minimum level at which the an alyte can

be reliably detected.

检测限是通过分析样品已知浓度的被分析物，从而建立其可稳定检测的最低浓度水平。

2 Limit of Quantitation (LOQ)

定量限(LOQ)

The qua ntitati on limit of an in dividual an alytical procedure is the lowest

amount of analyte in a sample which can be quantitatively determined

with suitable precisi on and accuracy.

分析方法中的定量限是指样品中被分析物能够被定量检测并保证一定精密度和准确度的最

低浓度。

The limit of quantitation is a parameter of quantitative assays for low levels

of compounds in sample matrices, and is used particularly for the determ in ati on of

impurities an d/or degradati on products.

定量限是在样品中低浓度化合物被定量检测的参数，该参数经常被用于杂质和/或降

解产物的测定。

3 system suitability

系统适用性

System suitability tests are an in tegral part of gas and liquid