QUALITY IMPLICATION From Drug Purchasing to Drug Administration

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QUALITY IMPLICATION From Drug Purchasing to Drug Administration

QUALITY IMPLICATION From Drug Purchasing to Drug Administration

���� • ������� - production - quality control (BP USP EP IP TP)

���� • ������� - production - quality control (BP USP EP IP TP)

“����� � ” British Pharmacopoeia Thai Pharmacopoeia United States Pharmacopoeia International Pharmacopoeia European Pharmacopoeia

“����� � ” British Pharmacopoeia Thai Pharmacopoeia United States Pharmacopoeia International Pharmacopoeia European Pharmacopoeia

������� • ���������� chlorpheniramine maleate tablet – chlorpheniramine maleate tablet contain not less than

������� • ���������� chlorpheniramine maleate tablet – chlorpheniramine maleate tablet contain not less than 90. 0 percent and not more than 110. 0 percent of the labeled amount of C 16 H 19 Cl. N 2. C 4 H 4 O 4 – Identification – Dissolution – Uniformity of dosage unit – Assay

Certificate of analysis (COA) Product name : Lot number : Lot size : Description

Certificate of analysis (COA) Product name : Lot number : Lot size : Description : Content : Test (parameters) Identification Dissolution test Uniformity of dosage unit Assay Requirements (Specifications) Results Meet the requirements %LA

Dissolution Profile % drug dissolved 100 50 Test Reference 0 30 60 Time (min)

Dissolution Profile % drug dissolved 100 50 Test Reference 0 30 60 Time (min)

Plasma concentration (ng/m. L) 800 Test 600 Reference 400 200 0 12 24 36

Plasma concentration (ng/m. L) 800 Test 600 Reference 400 200 0 12 24 36 Time (hr) 48

������� �� ��������� �� Furosemide tab ������ �� off white - pale ������ well

������� �� ��������� �� Furosemide tab ������ �� off white - pale ������ well closed ��� yellow light resist container photodecomposition Phenytoin cap ������ hygroscopic ���� �� tight light resist protect from moisture container

������� Freeze Cold Refrigerate Cool Control RT Warm -20 - -10 <8 2– 8

������� Freeze Cold Refrigerate Cool Control RT Warm -20 - -10 <8 2– 8 8 – 15 15 – 30 30 - 40

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