穩(wěn)定性試驗方案

1、Stability Study Protocol穩(wěn)定性方案 穩(wěn)定性方案Chloroquine Phosphate Tablets Protocol No.: PRO-ST-001-2008(1.2)磷酸氯喹片 方案編號：PRO-ST

2、-001-2008(1.2)Stability Lab 穩(wěn)定性實驗室Stability Study Protocol for Exhibit Batch of Chloroquine Phosphate Tablets USP, 250mg 規(guī)格為 250 mg 的 USP 磷酸氯喹片長期、中期及加速穩(wěn)定性研究方案Project No. 項目號 DP-ST-001-2008Prepared By: Da

3、te:起草者： 日期： Reviewed By QA: Date:審核者： 日期： Approved By: Date:批準(zhǔn)者： 日期： Starting

4、 Date: Completed Date:開始日期： 結(jié)束日期： Stability Study Protocol穩(wěn)定性方案 穩(wěn)定性方案Chloroquine Phosphate Tablets Protocol No.: PRO-ST-001-2008

5、(1.2)磷酸氯喹片 方案編號：PRO-ST-001-2008(1.2)Stability Lab Page 1/ 9穩(wěn)定性實驗室1. Purpose目的 目的The

6、 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 environmen

7、tal 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

8、 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. 此穩(wěn)定性研究的目的是為了考察磷酸氯喹

9、片在環(huán)境因素的影響下(例如：溫度和濕度)其性質(zhì)、 規(guī)格、降解產(chǎn)物和含量等隨時間而變化的規(guī)律，依據(jù)穩(wěn)定性研究的數(shù)據(jù)確定該產(chǎn)品的儲藏條件 和有效期。2. Scope范圍 范圍This procedure is applicable to Finished Product Stability Lab at Hisun Pharmaceutical (Hangzhou) Co. Ltd. Fuyang, Hangzhou.適用于浙江臺州海正藥

10、業(yè)成品藥穩(wěn)定性實驗室。3. References參考資料 參考資料3.1 ICH Harmonized Triparties Guideline for Stability Testing of New Drug Substances and Drug Product 06, 2003. [ICH Q1A (R2)]新原料藥和新制劑的穩(wěn)定性測試指南 06, 2003. [ICH Q1A(R2)]3.2 ASSAY METHOD VAL

11、IDATION REPORT FOR CHLOROQUINE PHOSPHATE, USP, API AND CHLOROQUINE PHOSPHATE, USP TABLETS, 250 mg AND 500 mg. (ARD-VDR- FPTM025A)磷酸氯喹原料藥、250mg 和 500mg 片的含量測定方法驗證報告。3.3 RELATED SUBSTANCES METHOD VALIDATION REPORT FOR CHL

12、OROQUINE PHOSPHATE, USP, API AND CHLOROQUINE PHOSPHATE, USP TABLETS, 250 mg AND 500 mg. (ARD-VDR-FPTM025B)磷酸氯喹原料藥、250mg 和 500mg 片有關(guān)物質(zhì)方法驗證報告。3.4 DISSOLUTION METHOD VALIDATION REPORT FOR CHLOROQUINE PHOSPHATE, USP TABLE

13、TS, 250 mg AND 500 mg. (ARD-VDR-FPTM025C)磷酸氯喹 250mg 和 500mg 片溶出度方法驗證報告。4. General Information基本信息 基本信息4.1 Stability Samples穩(wěn)定性樣品 穩(wěn)定性樣品4.1.1 One Exhibit Batch for 250mg strength will be included in the stability study.規(guī)格為