Jon Clark Stability Report

Stability Study Data Report

Study Number: STS001A	Protocol Code: Pre-approval stability Protocol	Sample Orientation: Upright	Starting Date: 2000-01-01	Storage Condition: 40 PlusMinus 2 Deg C/75 PlusMinus 5%RH
Lot/Batch Number: WD001A	Product Code: Cureall 100	Specification Code: ST-SPEC 001	Dosage Form: From DATA Dictionary	Route of Administration: From DATA Dictionary
Product Strength: 100 units	Manufacturing Site: FDA	Product Manufacturing Date: 1999-12-31	Drug Substance Manufacturing Sites and Lot(s)/Batch(es): Site -- Write here or Link | Lot/Batch -- xyz 001, xyz 002
Expiration Dating: 24 month	Amount in Container: 100 tablets	Container/Closure Code: PK001	Container/Closure Description: 100 mL white opaque round HDPE bottle with 38 mm CRC cap

 

Specification			0 month	1 month	2 month	3 month
Test	Acceptance Criteria	Analytical Procedure
Description	White film-coated, modified capsule shaped, biconvex, beveled edge tablet debossed with 001 on one side and WD on the other side.	Visual	Conformed	Conformed	Conformed	Conformed
Drug release	NLT 20% and NMT 55% in one hour	FP001-2	47.7% (12)	42.0% (12)	45.2% (12)	41.0% (12)
Drug release	NLT 80% in four hours	FP001-2	93%	96%	92%	94%
Assay	NLT 95.0% and NMT 105.0%	FP001-4	98.701% (2)	97.1%	97.5%	96.8%
Single impurity	NMT 1.0%	FP001-5	LT 0.1%	0.1%	0.1%	0.2%
Total impurities	NMT 2.0%	FP001-5	0.4%	0.4%	0.5%	0.5%

Note: 1. This is for demo purpose only.

 

Stability Study Data Report 2

Study Number: STS001B	Protocol Code: Pre-approval stability Protocol	Sample Orientation: Upright	Starting Date: 2000-01-01	Storage Condition: 40 PlusMinus 2 Deg C/75 PlusMinus 5%RH
Lot/Batch Number: WD001B	Product Code: Cureall 100	Specification Code: ST-SPEC 001	Dosage Form: From DATA Dictionary	Route of Administration: From DATA Dictionary
Product Strength: 100 units	Manufacturing Site: CDER	CDERProduct Manufacturing Date: 1999-12-30	Drug Substance Manufacturing Sites and Lot(s)/Batch(es): Site -- Write here or Link | Lot/Batch -- xyz 001, xyz 002
Expiration Dating: 24 month	Amount in Container: 500 tablets	Container/Closure Code: PK002	Container/Closure Description: 500 mL white opaque round HDPE bottle with 53 mm metal screw cap

 

Specification			0 month	1 month	2 month	3 month
Test	Acceptance Criteria	Analytical Procedure
Description	White film-coated, modified capsule shaped, biconvex, beveled edge tablet debossed with 001 on one side and WD on the other side.	Visual	Conformed	Conformed	Conformed	Conformed
Drug release	NLT 20% and NMT 55% in one hour	FP001-2	46.1% (12)	42.0% (12)	45.2% (12)	42.1% (12)
Drug release	NLT 80% in four hours	FP001-2	98%	96%	92%	94%
Assay	NLT 95.0% and NMT 105.0%	FP001-4	99.6%	97.1%	97.5%	96.8%
Single impurity	NMT 1.0%	FP001-5	LT 0.1%	0.1%	0.1%	0.2%
Total impurities	NMT 2.0%	FP001-5	0.5%	0.4%	0.5%	-

Note: 1. This is for demo purpose only.

 

Stability Study Data Report 3

Study Number: STS002L	Protocol Code: Pre-approval stability Protocol	Sample Orientation: Upright	Starting Date: 2000-01-01	Storage Condition: 25 PlusMinus 2 Deg C/60 PlusMinus 5%RH
Lot/Batch Number: WD002A	Product Code: Cureall 200	Specification Code: ST-SPEC 0020	Dosage Form: From DATA Dictionary	Route of Administration: From DATA Dictionary
Product Strength: 200 units	Manufacturing Site: CVM	Product Manufacturing Date: 1999-12-31	Drug Substance Manufacturing Sites and Lot(s)/Batch(es): Site -- Write here or Link | Lot/Batch -- xyz 001, xyz 002
Expiration Dating: 24 month	Amount in Container: 100 tablets	Container/Closure Code: PK003	Container/Closure Description: 100 mL white opaque round HDPE bottle with 38 mm CRC cap

 

Specification			0 month	3 month	6 month	9 month	12 month	18 month	24 month
Test	Acceptance Criteria	Analytical Procedure
Description	White film-coated, modified capsule shaped, biconvex, beveled edge tablet debossed with 001 on one side and WD on the other side.	Visual	Conformed	Conformed	Conformed	Conformed	Conformed	Conformed	Conformed
Drug release	NLT 20% and NMT 55% in one hour	FP001-2	46.1% (12)	42.0% (12)	45.2% (12)	42.1% (12)	42.0% (12)	45.2% (12)	43.7% (24)
Drug release	NLT 80% in four hours	FP001-2	95%	94%	96%	93%	90%	92%	93%
Assay	NLT 95.0% and NMT 105.0%	FP001-4	94.2%	94.2%	94.8%	95.3%	95.4%	95.8%	96.8%
Single impurity	NMT 1.0%	FP001-5	LT 0.1%	LT 0.1%	LT 0.1%	0.1%	0.1%	0.1%	0.2%
Total impurities	NMT 2.0%	FP001-5	0.3%	0.4%	0.4%	0.4%	0.5%	0.5%	0.6%

Note: 1. This is for demo purpose only.