Contents
目录Stability Lab
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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
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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
3.1 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)]
3.2 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。

3.3 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。

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3.4 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。

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FP Stability Lab
7.1Intermediate Reports
中期报告
The stability laboratory will issue intermediate reports according to Appendix B within 30 days at each testing time points. The written
explanation should be provided if test result is not reported within required
time.
在检测点30天内对该检测点数据按附件B进行中期报告，如果没有按规定时间进行报告，必须有书面说明。

7.2Summary Report
总结报告
On completion of the study, the stability laboratory will issue a report summary with signature and date according to appendix B.
在完成稳定性研究后，按照附件B进行总结报告。

7.3Stability Documents
稳定性文件夹
The stability documents should include the following, but not limited to:
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稳定性文件夹应该包括但不局限于以下内容：
●Name and description of drug product
品名及产品描述
●Manufacturer, batch No., batch size(s), mfg. date, package type and
package date
产品生产厂商、批号、批量、生产日期、包装类型和包装日期
●Drug product strength
产品规格
●API manufacturer/supplier
API厂商
●Method validation reports
方法验证报告
●All analytical and physical data, including identity test, chemistry
assay, physical test
所有检验数据，包括鉴别、含量及测试。

●Acceptance criteria
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质量标准
●Where applicable, a description of statistical methodology applied,
including parameters estimated, assumptions made, and model(s) used;
transformations, calculations or operations performed on the data; an
explanation and statement of the conclusions drawn from the statistical
analysis relative to the objective(s) of the study; the name(s) of software
employed in the statistical evaluations.
实验数据和结果所采用的分析方法、统计方法、转换计算、假设、采用模式及相应软件信息等，所得结论及相关说明。

●The numbers and titles of standard operating procedures applied
采用的Sop编号和标题
● A signed and dated statement of intermediate reports
中期报告
●The records of all samples, original data and testing reports
样品的原始数据和测试报告
●Requiring form for stability study
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稳定性研究申请表
8.Appendix
附件
Appendix B1: STABILITY STUDY SUMMARY REPORT (Hisun
products/ 250 mg)
附件B1：稳定性研究报告(海正产品/250mg)
Appendix B2: STABILITY STUDY SUMMARY REPORT (Brand)
附件B3：稳定性研究报告(Brand)
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