稳定性试验方案

Stability Study Protocol for Exhibit Batch of

Chloroquine Phosphate Tablets USP, 250mg

规格为250 mg的USP磷酸氯喹片

长期、中期及加速稳定性研究方案

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Prepared By: Date:

起草者：日期：

Reviewed By QA: Date:

审核者：日期：

Approved By: Date:

批准者：日期：

Starting Date: Completed Date:

开始日期：结束日期：

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Contents

目录

1.P u r p o s e目的 (1)

2.S c o p e范围 (1)

3.R e f e r e n c e s参考资料 (1)

4.G e n e r a l I n f o r m a t i o n基本信息 (1)

S t a b i l i t y S a m p l e s稳定性研究样品 (1)

P r o d u c t O u t l i n e样品概述 (1)

F o r m u l a t i o n处方 (1)

C o n t a i n e r-C l o s u r e S y s t e m s包装 (1)

L a b e l i n g标签 (1)

S a m p l e s a n d P a c k a g e样品与包装 (1)

5.S t a b i l i t y Te s t i n g稳定性测试 (1)

S a m pl e Rec ei pt a n d S to ra ge样品接收与储存 (1)

Storage Conditions and Testing Time Points储存条件与检测时间点 (1)

S a m p l i n g取样 (1)

Te s t i n g M a t r i x稳定性测试项目表 (1)

Parameters and Acceptance Criteria检测项目及质量标准 (1)

D e g r a d a t i o n p r o d u c t s降解产物 (1)

6.D a t a P r e s e n t a t i o n数据汇总 (1)

7.R e p o r t i n g报告 (1)

I n t e r m e d i a t e R e p o r t s中期报告 (1)

S u m m a r y R e p o r t总结报告 (1)

S t a b i l i t y D o c u m e n t s稳定性文件夹 (1)

8.A p p e n d i x附件 (1)

1.Purpose

目的

The purpose of stability testing is to provide evidence of how the Quality, Strength, Degradation Products and Purity of the Chloroquine Phosphate Tablets USP, 250mg will change with time under the influence of environmental room temperature and relative humidity conditions. Data collected from the stability study will enable recommended storage conditions and provide justification for establishing and submitting the data to regulatory authorities for approving the shelf life for marketing purposes.

In addition, 3 months of the stability data will be submitted to US FDA as required for submission purposes of the ANDA application.

此稳定性研究的目的是为了考察磷酸氯喹片在环境因素的影响下(例如：温度和湿度)其性质、规格、降解产物和含量等随时间而变化的规律，依据稳定性研究的数据确定该产品的储藏条件和有效期。

2.Scope

范围

This procedure is applicable to Finished Product Stability Lab at Hisun Pharmaceutical (Hangzhou) Co.

Ltd. Fuyang, Hangzhou.

适用于浙江台州海正药业成品药稳定性实验室。

3.References

参考资料

ICH Harmonized Triparties Guideline for Stability Testing of New Drug Substances and Drug Product06, 2003. [ICH Q1A (R2)]

新原料药和新制剂的稳定性测试指南06, 2003. [ICH Q1A(R2)]

ASSAY METHOD VALIDATION REPORT FOR CHLOROQUINE PHOSPHATE, USP, API AND CHLOROQUINE PHOSPHATE, USP TABLETS, 250 mg AND 500 mg. (ARD-VDR-FPTM025A)

磷酸氯喹原料药、250mg和500mg片的含量测定方法验证报告。

RELATED SUBSTANCES METHOD VALIDATION REPORT FOR CHLOROQUINE PHOSPHATE, USP, API AND CHLOROQUINE PHOSPHATE, USP TABLETS, 250 mg AND 500 mg.(ARD-VDR-FPTM025B)

磷酸氯喹原料药、250mg和500mg片有关物质方法验证报告。

DISSOLUTION METHOD VALIDATION REPORT FOR CHLOROQUINE PHOSPHATE, USP TABLETS, 250 mg AND 500 mg. (ARD-VDR-FPTM025C)

磷酸氯喹250mg和500mg片溶出度方法验证报告。

4.General Information

基本信息

4.1Stability Samples

稳定性样品

4.1.1 One Exhibit Batch for 250mg strength will be included in the stability study.

规格为250mg的磷酸氯喹片各一批。

4.1.2 One batch of 250mg reference product will also be placed on stability study.

规格为250mg和的磷酸氯喹对照制剂各一批。