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
Project No. 项目号 | DP-ST-001-2008 |
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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：
Contents
1.
Purpo
目的
The purpo 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 stor
age conditions and provide justification for establishing and submitting the data to regulatory authorities for approving the shelf life for marketing purpos.
In addition, 3 months of the stability data will be submitted to US FDA as required for submission purpos 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
3.1 ICH Harmonized Triparties Guideline for Stability Testing of New Drug Substances and Drug Product 06, 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。
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。
4.2
Product Outline
样品信息
Batch No. 批号 | Strength 规格(mg) | Package Size 包装规格 | Batch Size 批量(Tablets) | Mfg. Date 生产日期 | Pkg. Date 包装日期 | Manufacturer 生产商 |
| 250 | 50 Tablets/ Bottle | 360,,000 | | | Hisun 海正 |
100 Tablets/ Bottle | |
500 Tablets/ Bottle | |
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61924A | 250 | 50 Tablets/ Bottle | NA | NA | NA | West-ward |
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4.3Formulation
处方
4.3.1The formulation of Chloroquine Phosphate USP Tablets, 250 mg, is as follows:
规格为250mg的USP磷酸氯喹片处方如下：Table 1. Formula and batch size
Batch size: 360,000 tablets ( 172.8 Kg )
成分 Ingredients | mg / 片 mg / tablet | Kg / 批 Kg / batch | Manufacturer |
原料药API* | 250 | 90 | IPCA |
微晶纤维素(102) MCC (Type 102) | 154 | 55.44 | JRS |
二水磷酸氢钙 Dibasic Calcium Phosphate Dihydrate | 40 | 14.4 | JRS |
滑石粉Talc | 24 | 8.64 | Merck |
胶体二氧化硅 Colloidal Silicon Dioxide (Aerosil 200) | 4.8 | 1.728 | Degussa |
硬脂酸镁 Magnesium Stearate | 7.2 | 2.592 | Peter Greven |
总量Total | 480 | 172.8 | |
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