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¬“√°— …“‚√§„π√–∫∫∑“߇¥π‘ À“¬„® Triprolidine HCl and pseudoephedrine HCl tablet (‰µ√‚æ√≈‘¥π’ ·≈–´‚Ÿ ¥Õø’ ¥ï √’π‰Œ‚¥√§≈Õ‰√¥å ™π¥‘ ‡¡Á¥) À—«¢âÕ∑’˵√«® Õ∫§ÿ≥¿“æ - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) -§«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µ≈à –Àπ«à ¬(Contentuniformity) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ∫√…‘ —∑∑’˺“à π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈Õ◊ ° √“¬™ÕË◊ ºŸâº≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg .No. Trade name ∑’ ‚Õ ‡§¡‘§—≈ å 2A 133/36 Sufed 51 T.O. Chemical (1979) Co., Ltd. 2A 23/33 Nasolin 2A 655/28 Policold ‰∑¬π§√æ—≤π“ 2A 90/40 Nasifed Thai Nakorn Patana Co.,Ltd. 2A 173/41 Colidine 2A 372/27 Polyfed ‚æ≈‘ø“√å¡ Polipharm Co., Ltd. ∫√Ÿ æ“‚Õ ∂ Burapha Dispensary Co.,Ltd. ∑’ ·¡π ø“√å¡“ T. Man Pharma Co., Ltd. ‰∫‚Õ·≈∫ Biolab Co., Ltd.

¬“√°— …“‚√§„π√–∫∫∑“߇¥π‘ À“¬„® Terbutaline sulfate injection, 0.5 mg/ml (‡∑Õ√∫å Ÿ∑“≈’π´—≈‡øµ ™π‘¥©’¥) À—«¢âÕ∑’˵√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - §à“§«“¡‡ªìπ°√¥ - ‡∫  (pH) ∫√‘…∑— ∑’ºË “à π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈◊Õ° √“¬™ÕË◊ ºŸâº≈‘µ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg .No. Trade name Õߧ尓√‡¿ —™°√√¡ - Terbutal Government Pharmaceutical Organization 52 Terbutal 1A 395/30 Baltic ·Õ≈.∫’.‡Õ .≈“∫Õ√“∑Õ√’ å

¬“√—°…“‚√§„π√–∫∫∑“߇¥‘πÀ“¬„® Terbutaline sulfate tablet, 2.5 mg (‡∑Õ√∫å ∑Ÿ “≈π’ ´—≈‡øµ™π‘¥‡¡Á¥) À—«¢âÕ∑’˵√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - §à“‡∫’ˬ߇∫π®“°πÈ”Àπ—°‡©≈’ˬ (Weight variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - ∫√‘…—∑∑’˺à“π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈◊Õ° ∫√…‘ —∑∑’˺à“π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈◊Õ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Trade name Manufacturer Reg .No. Framagon ∫“ß°Õ° ·≈∫ ·Õπ¥å §Õ ‡¡µ°‘ 1A 54/38 Bucanyl 53 Bangkok Lab & Cosmetic Co., 1A 72/41 1A 1462/28 Turbuline ∫√Ÿ æ“‚Õ ∂ 1A 32/39 Bronconyl Burapha Dispensary Co., Ltd. 1A 2254/29 Bronchonyl 1A 417/29 Terbutaline ‡®√‘≠‡¿ —™·≈∫ 1A 1158/28 Charoen Bhaesaj Lab Co., Ltd. Bucaril 𑫉≈øá ø“√å¡“ New Life Pharma Co., Ltd. ø“√å¡“ —πµå ≈“∫Õ√“∑Õ√’Ë å Pharmasant Lab. Co., Ltd. ∑’ ‚Õ ‡§¡‘§—≈ å T.O. Chemicals (1979) Co., Ltd. ¬‚Ÿ ∑‡ªï¬π Utopian Co., Ltd.

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¬“√°— …“‚√§∑“ß√–∫∫ª√– “∑ - Carbamazepine oral suspension - Diazepam tablet - Phenytoin capsule 55

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ Carbamazepine oral suspension (§“√∫å “¡“‡´ªïπ ™π¥‘ π”È ·¢«πµ–°Õπ ”À√∫— √—∫ª√–∑“π) À—«¢âÕ∑’˵√«® Õ∫§ÿ≥¿“æ - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient ) - ª√‘¡“≥°“√ªπ‡ªóôÕπ‡™◊ÈÕ®ÿ≈‘π∑√’¬å (Microbial Limit) ∫√‘…∑— ∑’˺à“π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººâŸ ≈‘µ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Trade name Manufacturer Reg .No. Tegretol 2 % ‚π«“∑‘  ø“√å¡“ 1C 37/42 Novartis Pharma S.A. Switzerland 56

¬“√°— …“‚√§∑“ß√–∫∫ª√– “∑ Diazepam tablet (‰¥Õ–´·’ æ¡ ™π¥‘ ‡¡¥Á ) À—«¢âÕ∑’˵√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) -§«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µ≈à –Àπ«à ¬(Contentuniformity) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ∫√…‘ ∑— ∑Ë’º“à π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈Õ◊ ° √“¬™Õ◊Ë ºŸâº≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Trade name Manufacturer Reg .No. Diazepam- 2 Õߧ尓√‡¿ —™°√√¡ - Diazepam- 5 Government Pharmaceutical - Organization 57

¬“√°— …“‚√§∑“ß√–∫∫ª√– “∑ Phenytoin capsule, 100 mg (øï‰π‚∑Õπ‘ ™π‘¥·§ª´Ÿ≈) À—«¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ ®Ÿ πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - §à“‡∫’ˬ߇∫π®“°πÈ”Àπ—°‡¡Á¥¬“‡©≈’ˬ (Weight variation) À√◊Õ -§«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µ≈à –Àπ«à ¬(Contentuniformity) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - °“√µ√«® Õ∫ Related substances (‡©æ“–º≈‘µ¿—≥±å)* ∫√…‘ ∑— ∑’ºË “à π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈◊Õ° √“¬™◊ÕË ººŸâ ≈‘µ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg .No. Trade name ·Õµ·≈𵑧 ≈“∫Õ√“∑Õ√’Ë å 1 A 1657/27 Ditoin Atlantic Lab. Corp. Ltd. Molantin * Dilantin ‚¡‡¥Õ√åπ ‡¡πŸ 1A 1072/44 Pepsytoin 58 Modern Manu Ltd. Parke-Davis, Pfizer Parke Davis, 1 C 285/41 Warner-Lambert, Inc Zeulig Pharma æÕπ¥å ‡§¡‘§Õ≈ å 1 A 1294/41 Pondûs Chemicals (Thailand) ß∫ª√–¡“≥ :  ”π°— ß“πÀ≈°— ª√–°—π ¢ÿ ¿“æ·Ààß™“µ‘

¬“≈¥‰¢¡—π„πÀ≈Õ¥‡≈◊Õ¥ - Atorvastatin film coated tablet 59

¬“≈¥‰¢¡—π„πÀ≈Õ¥‡≈Õ◊ ¥ Atorvastatin film coated tablet (Õ∑Õ√å«“ ‡µµ‘π ™π¥‘ ‡¡Á¥‡§≈◊Õ∫ø≈î å¡) À—«¢âÕ∑’˵√«® Õ∫§ÿ≥¿“æ (µ“¡∑–‡∫’¬πµ”√—∫¬“) - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) -§«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µ≈à –Àπ«à ¬(Contentuniformity) ∫√…‘ —∑∑Ë’ºà“π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈◊Õ° √“¬™◊ÕË ºŸºâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg .No. Trade name ‰ø‡´Õ√å ‰Õ√å·≈π¥å ø“√å¡“´µŸ ‘§Õ≈ å 1 C 117/47(N) Lipitor 20 mg Pfizer Ireland Pharmaceuticals 60 ß∫ª√–¡“≥ :  ”π—°ß“πÀ≈°— ª√–°—π ¢ÿ ¿“æ·Ààß™“µ‘

¬“√—°…“‡∫“À«“π -Metformin HCl tablet 61

¬“√°— …“‡∫“À«“π Metformin HCl tablet 500 mg (‡¡∑øÕ√å¡π‘ ‰Œ‚¥√§≈Õ‰√¥å ™π‘¥‡¡¥Á ) À—«¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - °“√µ√«® Õ∫ Related substances ∫√…‘ ∑— ∑˺’ à“π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈Õ◊ ° √“¬™ËÕ◊ ºŸºâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg .No. Trade name Õߧ尓√‡¿ —™°√√¡ 1 A 113/45 Metformin HCl Government Pharmaceutical Organization ∫√Ÿ æ“‚Õ ∂ 1 A 305/41 Buformin Burapha dispensary Co., Ltd. ¡‘≈≈‘‡¡¥ 1 A 78/45 Metfor 62 Millimed Co., Ltd 𑥓 ø“√å¡“ 1 A 415/38 Glucoformin Nida Pharma Inc., Ltd ø“√å¡“ —πµå ·≈∫Õ√“∑Õ√’Ë å 1 A 454/34 Gluzolyte Pharmasant Lab Co., Ltd ‚ª≈‘ø“√å¡ 1 A 60/40 Poliformin Polipharm Co., Ltd ß∫ª√–¡“≥ :  ”π—°ß“πÀ≈°— ª√–°π—  ¢ÿ ¿“æ·Ààß™“µ‘

¬“µ“â π‡™◊ÕÈ √“ - Fluconazole capsule 63

¬“µâ“π‡™◊ÈÕ√“ Fluconazole capsule 200 mg (ø≈‚Ÿ §π“‚´≈ ™π‘¥·§ª´Ÿ≈) À—«¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - §à“‡∫’ˬ߇∫π®“°πÈ”Àπ—°‡©≈’ˬ (Weight variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ∫√…‘ —∑∑ºË’ à“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™◊Ëպ⺟ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg .No. Trade name Õߧ尓√‡¿ —™°√√¡ - Fluzoral Government Pharmaceutical 64 Organization ß∫ª√–¡“≥ :  ”π—°ß“πÀ≈—°ª√–°—π ÿ¢¿“æ·Ààß™“µ‘

¬“ª√–‡¿∑ÕË◊πÊ 65 - Albendazole tablet - Dexamethasone injection - Dexamethasone tablet - Propylthiouracil tablet - Timolol maleate eye drop

¬“ª√–‡¿∑Õ◊πË Ê Albendazole tablet 200 mg (·Õ≈‡∫𥓂´≈ ™π‘¥‡¡¥Á ) À—«¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ ®Ÿ πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) -§«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µ≈à –Àπ«à ¬ (Content uniformity) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ∫√…‘ —∑∑º’Ë à“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ËÕ◊ ºâºŸ ≈‘µ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg .No. Trade name Õߧ尓√‡¿ —™°√√¡ 1 A 1044/44 Falben 66 Government Pharmaceutical Organization ß∫ª√–¡“≥ :  ”π°— ß“πÀ≈—°ª√–°π—  ÿ¢¿“æ·Ààß™“µ‘

¬“ª√–‡¿∑ÕπË◊ Ê Dexamethasone injection (‡¥°Á ´“‡¡∑“‚´π ™π‘¥©’¥) À—«¢âÕ∑’˵√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - §à“§«“¡‡ªìπ°√¥ - ‡∫  (pH ) ∫√…‘ —∑∑º’Ë à“π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈◊Õ° √“¬™ÕË◊ ºŸâº≈‘µ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Trade name Manufacturer Reg .No. Dexamethasone Õߧ尓√‡¿ —™°√√¡ - 4 mg/m Government Pharmaceutical Organization Dexon 4 mg/ml ‡¬π‡πÕ√—≈ ¥√—° å ‡Œâ“ å 1A 1009/29 Dexamo General Drugs House Co., Ltd. 5 mg/ml ‚¡‡¥Õ√åπ‡¡πŸ 1A 2525/28 Decordex 67 Modern Manu Co., Ltd. 4 mg/ml 𑥓 ø“√å¡“ 1A 251/30 Nida Pharma Inc. Ltd.

¬“ª√–‡¿∑Õ◊ËπÊ Dexamethasone tablet, 0.5 mg (‡¥Á°´“‡¡∑“‚´π ™π¥‘ ‡¡¥Á ) À—«¢âÕ∑’˵√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ ®Ÿ πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - §à“‡∫’ˬ߇∫π®“°πÈ”Àπ—°‡©≈’ˬ (Weight variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ∫√‘…—∑∑’˺“à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ËÕ◊ ºŸâº≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg .No. Trade name ·Õµ·≈𵑧 ≈“∫Õ√“∑Õ√’Ë å 1A 467/33 Dexamethasone Atlantic Lab. 68 𑫉≈øá ø“√å¡“ 1A 505/33 Dexamethasone Newlife Pharma Co., Ltd .

¬“ª√–‡¿∑Õ◊πË Ê Propylthiouracil tablet, 50 mg (‚æ√æ‘≈‰∑‚Õ¬Ÿ√“´‘≈ ™π‘¥‡¡¥Á ) À—«¢âÕ∑’˵√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - §à“‡∫’ˬ߇∫π®“°πÈ”Àπ—°‡©≈’ˬ (Weight variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ∫√‘…—∑∑ºË’ à“π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈◊Õ° √“¬™◊ËÕºŸºâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg .No. Trade name Õߧ尓√‡¿ —™°√√¡ 1A 138/43 Propylthiouracil Government Pharmaceutical Organization 69

¬“ª√–‡¿∑ÕËπ◊ Ê Timolol maleate eye drop (∑‚‘ ¡≈Õ≈ ¡“≈’‡Õ∑ ™π¥‘ À¬Õ¥µ“) À—«¢âÕ∑’˵√«® Õ∫§ÿ≥¿“æ - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - §à“§«“¡‡ªìπ°√¥ - ‡∫  (pH) - °“√µ√«® Õ∫§«“¡ª√“»®“°‡™◊ÈÕ (Sterility Test ) ∫√…‘ ∑— ∑’˺“à π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈◊Õ° √“¬™◊Ëպ⟺≈‘µ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg .No. Trade name ·Õ≈§Õπ ·≈∫Õ√“∑Õ√’Ë å 1C 194/41 Timolol maleate Alcon laboratories,Belgium Alcon · ß‰∑¬°”ª“π’ 1A 799/28 Glauco-Oph Seng Thai Company 1A 399/39 Timodrop 70 ‰∫‚Õ·≈∫ Biolap Co.,Ltd.

¿“§ºπ«° ¿“§ºπ«° ¿“§ºπ«° 71

¢Õâ °”Àπ¥¿“™π–∫√√®ÿ ”À√∫— ¬“·§ª´Ÿ≈·≈–¬“‡¡¥Á Container Specifications for Capsules and Tablets (From : The United States Pharmacopeia. USP 29-2006) µ”√“¬“ USP 29 ‰¥â°”Àπ¥™π‘¥¢Õß¿“™π–∫√√®ÿ∑’Ë„™â ”À√—∫ ∫√√®¬ÿ “·§ª´Ÿ≈ ·≈–¬“‡¡Á¥ ‡æÕË◊ °“√·∫àß∫√√®ÿ„π°“√®à“¬¬“„Àºâ ⪟ «É ¬ µ“¡ ª√–‡¿∑¢Õß¿“™π–∫√√®ÿ ¥—ßπ’È ¿“™π–∫√√®ªÿ ¥î Õ¬à“ߥ’ (Well-closed container) À¡“¬∂ß÷ ¿“™π–∫√√®∑ÿ  Ë’ “¡“√∂ªÕÑ ß°π— ∫√√®¿ÿ ≥— ±¿å “¬„π®“°°“√ ªπ‡ªóôÕπ¢Õß “√∑‡’Ë ªìπ¢Õß·¢Áß √«¡∑—ÈߪÑÕß°π— °“√ ≠Ÿ ‡ ¬’ ∫√√®¿ÿ —≥±¿å “¬ „µâ ¿“«–∑«—Ë ‰ª ∑ß—È °“√À¬∫‘ „™â °“√¢π ßà °“√‡°Á∫√—°…“ ·≈–°“√®”Àπ“à ¬ ¿“™π–∫√√®ªÿ πàπ (Tight container) À¡“¬∂ß÷ ¿“™π–∫√√®∑ÿ  ’Ë “¡“√∂ªÕÑ ß°π— ∫√√®¿ÿ ≥— ±¿å “¬„π®“°°“√ ªπ‡ªôóÕπ¢Õß “√∑Ë’‡ªìπ¢Õß·¢Áß ¢Õ߇À≈« ·≈– ¿“«–∑Ë’‡ªìπ‰Õ √«¡∑È—ß ªÕÑ ß°π— °“√ ≠Ÿ ‡ ¬’ ∫√√®¿ÿ ≥— ±¿å “¬„π °“√‡°¥‘ °“√™πÈ◊ ‡À≈« (deliquescence) 72 °“√‡¬È‘¡‡À≈« (efflorescence) À√◊Õ°“√√–‡À¬¢Õß∫√√®ÿ¿—≥±å¿“¬„µâ  ¿“«–∑«Ë— ‰ª ∑ßÈ— °“√À¬∫‘ „™â °“√¢π ßà °“√‡°∫Á √°— …“ ·≈–°“√®”Àπ“à ¬ ‡¡ÕË◊ ‡ªî¥„™â·≈â« “¡“√∂ªî¥ π‘∑‰¥â¥—߇¥‘¡  ”À√—∫‡¿ —™¿—≥±å∑’Ë¡’¢π“¥„™â§√È—ß ‡¥¬’ «Õ“®„™â ¿“™π–∑∫’Ë ¥— °√®’ πÕ“°“»‡¢“â ‰¡‰à ¥â (hermetic container) ·∑π

¿“™π–∫√√®ÿªÕÑ ß°—π· ß (Light-resistant container ) À¡“¬∂÷ß ¿“™π–∫√√®ÿ∑’Ë “¡“√∂ªÑÕß°—π ‘Ëß∑’Ë∫√√®ÿ¿“¬„π®“° Õ∑‘ ∏æ‘ ≈¢Õß· ß‚¥¬§≥ÿ  ¡∫µ— ‡‘ ©æ“–¢Õß« — ¥∑ÿ ª’Ë √–°Õ∫„π¿“™π–∫√√®πÿ π—È Ê √«¡∑—Èß°“√„™â«— ¥ÿ∑÷∫· ß‡§≈◊Õ∫ÀàÕÀâÿ¡¥â“ππÕ°„π°√≥’¢Õß¿“™π–∫√√®ÿ ∑’Ë∑”¥â«¬«— ¥ÿ„  ‰¡à¡’ ’ À√◊Õ«— ¥ÿ‚ª√àß· ß µâÕß “¡“√∂ªÑÕß°—π· ß‰¥â µ≈Õ¥Õ“¬ÿ°“√„™âß“π ·≈–√–∫ÿ„π©≈“°Õ¬à“ß™—¥‡®π ¿“™π–∫√√®ÿ™π‘¥π’È „™â∫√√®ÿ‡¿ ™— ¿—≥±å∑Ë’µ”√“¬“√–∫«ÿ “à ªÕÑ ß°—π· ß (protect from light) ‚¥¬· ß∑Ë’Õ“®∑”Õ—πµ√“¬µàÕ‡¿ —™¿—≥±å®–‡ªìπ· ß∑’˧«“¡¬“« §≈π◊Ë „π™«à ߢÕß· ßÕ≈ÿ µ√“‰«‚Õ‡≈µ ·≈–„π∑πË’ ‰È’ ¥§â ¥— ≈Õ°√“¬™Õ◊Ë µ”√∫— ¬“„π USP 29 ‡©æ“–∑’Ë°”Àπ¥„Àâ∫√√®ÿ„π¿“™π–∫√√®ÿªî¥·πàπ À√◊Õ ¿“™π– ∫√√®ªÿ ¥î Õ¬“à ߥ’ ·≈–ªÕÑ ß°π— · ß‡¡Õ◊Ë ¡°’ “√·∫ßà ∫√√®„ÿ Àºâ ªŸâ «É ¬ ´ß÷Ë  “¡“√∂ ¥√Ÿ “¬≈–‡Õ¬’ ¥„πÀ«— ¢âÕ packaging and storage ¢Õß·µà≈– monograph „πµ”√“¬“¥—ß°≈“à « 73

µ”√∫— ¬“∑Ë’„™â¿“™π–∫√√®ªÿ ¥î ·πàπ·≈–ªÑÕß°π— · ß (Tight, Light-resistance) - Acepromazine Maleate Tablets - Acetaminophen and Codeine Phosphate Capsules - Acetaminophen and Codeine Phosphate Tablets - Albuterol Tablets - Alprazolam Tablets - Altretamine Capsules - Aminoglutethimide Tablets - Aminosalicylate Sodium Tablets - Aminosalicylic Acid Tablets - Anileridine Hydrochloride Tablets - Apomorphine Hydrochloride Tablets - Ascorbic Acid Tablets - Azathioprine Tablets - Belladonna Extract Tablets - Benzonatate Capsules - Beta Carotene Capsules - Bisoprolol Fumarate Tablets - Bromocriptine Mesylate Capsules - Bromocriptine Mesylate Tablets 74 - Bumetanide Tablets - Buspirone Hydrochloride Tablets - Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules - Calcifediol Capsules - Calcium with Vitamin D Tablets - Carbinoxamine Maleate Tablets - Cefaclor Tablets, Extended-Release - Chlorambucil Tablets - Chlordiazepoxide Tablets - Chlordiazepoxide and Amitriptyline Hydrochloride Tablets

µ”√∫— ¬“∑’„Ë ™¿â “™π–∫√√®ªÿ πàπ·≈–ªÑÕß°—π· ß 75 (Tight, Light-resistance) - Chlordiazepoxide Hydrochloride Capsules - Chlordiazepoxide Hydrochloride and Clidinium-Bromide Capsules - Chlorpheniramine Maleate and Phenylpropanolamine -Hydrochloride Capsules, Extended-Release - Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride Tablets, Extended-Release - Chlortetacycline Hydrochloride Tablets - Chondroitin Sulfate Sodium Tablets - Cimetidine Tablets - Clonazepam Tablets - Clorazepate Dipotassium Tablets - Red Clover Tablets - Cromolyn Sodium for Inhalation (in capsules) - Cyclizine Hydrochloride Tablets - Demeclocycline Hydrochloride Capsules - Demeclocycline Hydrochloride Tablets - Diazepam Capsules - Diazepam Capsules, Extended-Release - Diazepam Tablets - Diclofenac Sodium Tablets, Delayed-Release - Diltiazem Hydrochloride Tablets - Dipyridamole Tablets - Disulfiram Tablets - Divalproex Sodium Tablets, Delayed-Release - Doxycycline Capsules - Doxycycline Hyclate Capsules - Doxycycline Hyclate Capsules, Delayed-Release - Doxycycline Hyclate Tablets - Ephedrine Sulfate Capsules - Ergocalciferol Capsules - Ergocalciferol Tablets

µ”√—∫¬“∑„’Ë ™â¿“™π–∫√√®ÿª¥î ·πàπ·≈–ªÑÕß°—π· ß (Tight, Light-resistance) - Ergoloid Mesylates Capsules - Ergoloid Mesylates Tablets - Ergoloid Mesylates Tablets, Sublingual - Estradiol Tablets - Ethchlorvynol Capsules - Fexofenadine Hydrochloride Capsules - Finasteride Tablets - Flucytosine Capsules - Fluoxetine Capsules - Fluphenazine Hydrochloride Tablets - Flurazepam Hydrochloride Capsules - Fluvastatin Capsules - Furazolidone Tablets - Asian Ginseng Capsules - Asian Ginseng Tablets - Glucosamine Tablets - Glucosamine and Chondroitin Sulfate Tablets - Guaifenesin and Pseudoephedrine Hydrochloride Capsules - Guaifenesin, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Capsules 76 - Guanabenz Acetate Tablets - Guanadrel Sulfate Tablets - Guanfacine Tablets - Halazone Tablets for Solution - Haloperidol Tablets - Homatropine Methylbromide Tablets - Hydralazine Hydrochloride Tablets - Hydrocodone Bitartrate Tablets - Hydrocodone Bitartrate and Acetaminophen Tablets - Hydromorphone Hydrochloide Tablets

µ”√—∫¬“∑„Ë’ ™â¿“™π–∫√√®ªÿ ππà ·≈–ªÕÑ ß°π— · ß 77 (Tight, Light-resistance) - Hydroxychloroquine Sulfate Tablets - Hyoscyamine Sulfate Tablets - Iopanoic Acid Tablets - Labetalol Hydrochloride Tablets - Levodopa Capsules - Levodopa Tablets - Levothyroxine Sodium Tablets - Lorazepam Tablets - Meclofenamate Sodium Capsules - Mesalamine Capsules, Extended-Release - Methacycline Hydrochloride Capsules - Methamphetamine Hydrochloride Tablets - Methdilazine Hydrochloride Tablets - Methoxsalen Capsules - Methlergonovine Maleate Tablets - Metoclopramide Tablets - Metolazone Tablets - Metoprolol Tartrate Tablets - Metoprolol Tartrate and Hydrochlorothiazide Tablets - Metyrapone Tablets - Minerals Capsules - Minerals Tablets - Minocycline Hydrochloride Capsules - Minocycline Hydrochloride Tablets - Mirtazapine Tablets - Mitotane Tablets - Molindone Hydrochloride Tablets - Nafcillin Sodium Tablets - Nifedipine Capsules

µ”√∫— ¬“∑„’Ë ™â¿“™π–∫√√®ÿª¥î ·ππà ·≈–ªÑÕß°—π· ß (Tight, Light-resistance) - Nifedipine Tablets, Extended-Release - Nitrofurantoin Capsules - Nystatin Tablets - Oleovitamin A and D Capsules - Omeprazole Capsules, Delayed-Release - Oxandrolone Tablets - Oxaprozin Tablets - Oxybutynin Chloride Tablets - Oxycoone Hydrochloride Tablets - Oxycodone and Acetaminophen Capsules - Oxycodone and Acetaminophen Tablets - Oxycodone and Aspirine tablets - Oxytetracycline Tablets - Oxytetracycline and Nystatin Capsules - Oxytetracycline Hydrochloride Capsules - Papain Tablets for Topical Solution - Pentazocine Hydrochloride and Aspirin Tablets - Pentazocine and Naloxone Hydrochlorides Tablets - Perphenazine Tablets 78 - Phenylpropanolamine Hydrochloride Capsules - Phenylpropanolamine Hydrochloride Capsules Extended Release - Pimozide Tablets - Piroxicam Capsules - Potassium Perchlorate Capsules - Procarbazine Hydrochloride Capsules - Promazine Hydrochloride Tablets - Promethazine Hydrochloride Tablets - Pyrimethamine Tablets - Pyrivinium Pamoate Tablets

µ”√∫— ¬“∑’„Ë ™¿â “™π–∫√√®ªÿ πàπ·≈–ªÕÑ ß°—π· ß (Tight, Light-resistance) - Quinidine Gluconate Tablets, Extended-Release - Quinidine Sulfate Capsules - Ranitidine Tablets -- - Rauwolfia Serpentina Tablets - Reserpine Tablets - Reserpine and Chlorothiazide Tablets - Reserpine, Hydralazine Hydrochloride,and Hydrochlorothiazide Tablets - Riboflavin Tablets - Rifampin Capsules - Rifampin and Isoniazid Capsules - Rifampin, Isoniazid Capsules - Rifampin, Isoniazid, and Pyrazinamide Tablets - Rifampin, Isoniazid, Pyrazinamide, and Ethambutol Hydrochloride Tablets - Rimantadine Hydrochloride Tablets - Saw Palmetto Capsules - Scopolamine Hydrobromide Tablets - Selegiline Hydrobromide Tablets - Selegiline Hydrochloride Tablets - Spironolactone Tablets 79 - Spironolactone and Hydrochlorothiazide Tablets - Stanozolol Tablets - Sulfadimethoxine Tablets - Tetracycline Hydrochloride Capsules - Tetracycline Hydrochloride Tablets - Tetracycline Hydrochloride and Nystatin Capsules - Thiamine Hydrochloride Tablets - Thiethylperazine Maleate Tablets - Thioridazine Hydrochloride Tablets - Trazodone Hydrochloride Tablets

µ”√∫— ¬“∑’„Ë ™¿â “™π–∫√√®ªÿ πàπ·≈–ªÕÑ ß°—π· ß (Tight, Light-resistance) - Triamterene Capsules - Triamterene and Hydrochlorothiaazide Capsules - Triamterene and Hydrochlorothiazide Tablets - Triazolam Tablets - Trimethoprim Tablets - Triple Sulfa Vaginal Tablets - Triprolidine Hydrochloride Tablets - Triprolidine and Pseudoephedrine Hydrochlorides Tablets - Ubidecarenone Capsules - Ubidecarenone Tablets - Valerian Tablets - Verapamil Hydrochloride Tablets - Verapamil Hydrochloride Tablets, Extended-Release - Vitamin A capsules - Oil-Soluble Vitamins Capsules - Oil-Soluble Vitamins Tablets - Oil-and Water-Soluble Vitamins Capsules - Oil-and Water-Soluble Vitamins Tablets - Oil-and Water-Soluble Vitamins with Minerals Capsules 80 - Oil-and Water-Soluble Vitamins with Minerals Tablets - Water-Soluble Vitamins Capsules - Water-Soluble Vitamins Tablets - Water-Soluble Vitamins with Minerals Capsules - Water-Soluble Vitamins with Minerals Tablets - Warfarin Sodium Tablets - Zalcitabine Tablets - Zidovudine Capsules - Zidovudine Tablets

µ”√—∫¬“∑„’Ë ™¿â “™π–∫√√®ÿª¥î Õ¬à“ߥ’·≈–ªÕÑ ß°π— · ß 81 (Well- closed, Light - resistance) - Aspirin and Codeine Phosphate Tablets - Aspirin, Codeine Phosphate, Alumina, and Magnesia Tablets - Carbidopa and Levodopa Tablets - Chlorpromazine Hydrochloride Tablets - Clofibrate Capsules - Cyanocobalamin Co 57 Capsules - Cyanocobalamin Co 58 Capsules - Cocaine Hydrochloride Tablets for Topical Solution - Codeine Phosphate Tablets - Dapsone Tablets - Dihydrotachysterol Capsules - Dihydrotachysterol Tablets - Diphenoxylate Hydrochloride and Atropine Sulfate Tablets - Doxylamine Succinate Tablets - Dronabinol Capsules - Ergotamine Tartrate Tablets - Ergotamine Tartrate Tablets, Sublingual - Ergotamine Tartrate and Caffeine Tablets - Famotidine Tablets - Flutamide Capsules - Furosemide Tablets - Hyoscyamine Tablets - Isoniazid Tablets - Isoproterenol Hydrochloride Tablets - Leucovorin Calcium Tablets - Melphalan Tablets - Menadiol Sodium Diphosphate Tablets - Meperidine Hydrochloride Tablets - Mesoridazine Besylate Tablets - Metaproterenol Sulfate Tablets - Methimazloe Tablets

µ”√—∫¬“∑’„Ë ™¿â “™π–∫√√®ªÿ ¥î Õ¬“à ߥ’·≈–ªÑÕß°π— · ß (Well- closed, Light - resistance) - Metronidazole Tablets - Nystatin Vaginal Tablets - Oxprenolol Hydrochloride Tablets - Oxprenolol Hydrochloride Tablets, Extended-Release - Penbutolol Sulfate Tablets - Phytonadione Tablets - Pindolol Tablets - Prazosin Hydrochloride Capsules - Primaquine Phosphate Tablets - Probenecid and Colchicine Tablets - Probucol Tablets - Propranolol Hydrochloride Tablets - Quinidine Gluconate Tablets, Extended-Release - Quinidine Sulfate Tablets - Quinidine Sulfate Tablets, Extended-Release - Sotalol Hydrochloride Tablets - Sulfadiazine Tablets - Sulfadoxine and Pyrimethamine Tablets - Sulfamethoxazole Tablets - Sulfamethoxazole and Trimethoprim Tablets 82 - Sulfapyrideine Tablets - Sulfisoxazole Tablets - Tamoxifen Citrate Tablets - Temazepam Capsules - Thiothixene Capsules - Timolol Maleate and Hydrochlorothiazide Tablets - Trifluoperazine Hydrochloride Tablets - Triflupromazine Hydrochloride Tablets - Trimeprazine Tartrate Tablets - Trioxsalen Tablets - Triple Sulfa Vaginal Tablets

À—«¢Õâ ∑¥ Õ∫„πº≈‘µ¿—≥±å¬“ ”‡√®Á √ªŸ 83 Chromatographic purity À¡“¬∂÷ß °“√∑¥ Õ∫À“ª√‘¡“≥¢Õß “√ªπ‡ªóôÕπÀ√◊Õ  “√‡ ◊ËÕ¡ ≈“¬¥â«¬«‘∏’‚§√¡“‚∑°√“øïò Constituted solution À¡“¬∂÷ß À—«¢âÕ°“√∑¥ Õ∫ ”À√—∫¬“©’¥∑’ˇµ√’¬¡®“°ºß ¬“·Àâß ”À√—∫≈–≈“¬‡æ◊ËÕ©’¥ çDrug for Injectioné ª√–°Õ∫¥â«¬ °“√∑¥ Õ∫·≈– ß— ‡°µº≈¥«â ¬µ“„πÀ«— ¢Õâ CompletenessandClarity of Solution ·≈–‡æ◊ËÕ°“√∑¥ Õ∫À—«¢âÕ Particulate matter Deliverable volume À¡“¬∂÷ß °“√«—¥ª√‘¡“µ√∫√√®ÿ¢Õ߬“™π‘¥√—∫ª√–∑“π„π √Ÿª·∫∫¢Õ߇À≈« ‡¡ÕË◊ ¡°’ “√∂“à ¬„ ¿à “™π–ÕπË◊ «“à ¡ª’ √¡‘ “µ√∂°Ÿ µÕâ ß µ√ßµ“¡∑·’Ë ®ßâ ‰«∫â π©≈“° Disintegration À¡“¬∂÷ß °“√∑¥ Õ∫‡«≈“„π°“√·µ°°√–®“¬„π ¿“«– ∑’Ë°”Àπ¥¢Õ߬“ ”‡√Á®√Ÿª

Dissolution À¡“¬∂÷ß °“√∑¥ Õ∫°“√≈–≈“¬¢Õßµ—«¬“ ‡æ◊ËÕ®”·π° §ÿ≥¿“æ¢Õߺ≈‘µ¿—≥±å·≈–‡ªìπ¢âÕ∫àß™’È∑’Ë¥’°«à“°“√·µ°°√–®“¬ (disintegration) „π·ßà¢Õß°“√‡Õ◊ÈÕª√–‚¬™πå¢Õ߬“ ‡ªìπ°“√∑¥ Õ∫ in vitro ´÷Ëß®–· ¥ß§«“¡·µ°µà“ß√–À«à“ß º≈‘µ¿—≥±å ¬“¢Õß·µà≈–∫√‘…—∑ πÕ°®“°π’Ȭ—ß· ¥ß§«“¡·µ°µà“ß ¢Õßµ”√—∫ ªí®®—¬µàÕµ”√—∫ ·≈–æ“√“¡‘‡µÕ√åÕ◊ËπÊ„π°√–∫«π°“√º≈‘µ ´÷Ëß°“√∑¥ Õ∫°“√≈–≈“¬¢Õßµ—«¬“π’È Õ“® —¡æ—π∏åÀ√◊Õ‰¡à —¡æ—π∏å °—∫°“√∑¥ Õ∫ in vivo (bioavailability) ∂“â in vitro dissolution  ¡— æπ— ∏°å ∫— in vivo dissolution profile  “¡“√∂∫ßà ∫Õ°∂ß÷ bioavailability ‰¥â §Õ◊ °“√‡ÕÕ◊È ª√–‚¬™π„å π√“à ß°“¬ ´ß÷Ë À¡“¬∂ß÷ Õµ— √“‡√«Á ·≈–ª√¡‘ “≥µ«— ¬“ ”§≠— ∑∂’Ë °Ÿ ¥¥Ÿ ´¡÷ ‡¢“â  °àŸ √–·  ‡≈◊Õ¥·≈–‰ª¡’º≈ À√◊Õ‡Õ◊ÈÕª√–‚¬™πå ( available) ‰¥â ≥ ®ÿ¥ÕÕ°ƒ∑∏‘Ï ∂â“ in vitro dissolution ‰¡à —¡æ—π∏å°—∫ in vivo dissolution 84 ∂◊Õ‡ªìπ physical test §◊Õ ‡ªìπ°“√µ√«® Õ∫≈—°…≥–¢Õߺ≈‘µ¿—≥±å ‚¥¬»÷°…“°“√≈–≈“¬¢Õßµ—«¬“„π ¿“«–∑’Ë°”Àπ¥ ´÷Ë߉¡à “¡“√∂ ∫àß∫Õ°∂÷ß bioavailability Identification À¡“¬∂÷ß °“√µ√«®æ‘ Ÿ®πå‡Õ°≈—°…≥å¢Õß “√∑’˵âÕß°“√ ∑√“∫«à“µ√ß°—∫∑’Ë·®âß„π©≈“°

Loss on drying 85 À¡“¬∂÷ß ª√‘¡“≥ “√√–‡À¬‰¥â ∑’ËÀ“¬‰ª‡¡◊ËÕ∑”„Àâ·Àâß „π ¿“«–∑’Ë°”Àπ¥ ‡™àπ 𔉪Õ∫∑’ËÕÿ≥À¿Ÿ¡‘ 100_ C ‡ªìπ‡«≈“ 3 ™«—Ë ‚¡ß Microbial limit test À¡“¬∂÷ß °“√µ√«®°“√ªπ‡ªóôÕπ¢Õ߇™◊ÈÕ®ÿ≈‘π∑√’¬å „𬓠√—∫ª√–∑“π √«¡∑—Èß ¬“„™â¿“¬πÕ°∑’ˉ¡à®”‡ªìπµâÕߪ√“»®“°‡™◊ÈÕ (sterile) ‡™àπ syrup, suspension, aluminium hydroxide gel ‚¥¬°“√∑¥ Õ∫§«“¡ “¡“√∂„π°“√‡®√‘≠‡µ‘∫‚µ¢Õ߇™◊ÈÕ ®ÿ≈‘π∑√’¬å∑’ˇ°‘¥„πÕ“À“√‡≈’Ȭ߇™◊ÈÕ ´÷Ëß¡’µ—«Õ¬à“ß∑’˵Õâ ß°“√∑¥ Õ∫ º ¡Õ¬àŸ ‚¥¬„™â‡™◊ÈÕ¡“µ√∞“π¥—ßµàÕ‰ªπ’È ‰¥â·°à Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa ·≈– Salmonella typhi πÕ°®“°π’Ȭ—ß¡’«‘∏’°“√∑¥ Õ∫À“®”π«π‡™◊ÈÕ·∫§∑’‡√’¬ ·≈–‡™◊ÈÕ√“∑’ˇ°‘¥∫πÕ“À“√‡≈’Ȭ߇™◊ÈÕµ“¡Õÿ≥À¿Ÿ¡‘·≈–‡«≈“∑’Ë ‡À¡“– ¡ ´÷Ë߇√’¬°«à“ °“√µ√«® Õ∫ª√‘¡“≥®ÿ≈‘π∑√’¬å ‡™◊ÈÕ√“ ·≈– Enterobacteria ´÷Ëß·ª≈º≈‚¥¬· ¥ß®”π«π‡™◊ÈÕ Enterobacteria À√◊Õ ‡™◊ÈÕ√“ ¬’ µå ∑’Ë¡’Õ¬àŸ„πµ—«Õ¬à“ß

Minimum fill À¡“¬∂÷ß ª√‘¡“≥∑’Ë∫√√®ÿ„π¿“™π–Õ¬à“ßπâÕ¬µâÕßµ√ß°—∫∑’Ë ·®â߉«∫â π©≈“° „™â°—∫¬“ª√–‡¿∑ cream, aerosol, spray, gel ·≈– oint- ment ‡ªìπµâπ Particulate matter À¡“¬∂ß÷ °“√µ√«®«¥— ¢π“¥¢Õß Particles „π injection, irri- gation ‡ªìπµâπ «à“¡’¢π“¥µ“¡‡°≥±å∑’Ë°”Àπ¥À√◊Õ‰¡à pH °“√«—¥§«“¡‡ªìπ°√¥ - ‡∫  ¢Õß “√≈–≈“¬ Pyrogen / LAL test À¡“¬∂÷ß °“√∑¥ Õ∫À“ “√‰æ‚√‡®π «‘∏’∑’Ë„™â„πªí®®ÿ∫—π¡’ 86 2 «∏‘ §’ Õ◊ 1. °“√∑¥ Õ∫‚¥¬„™â°√–µà“¬‡ªìπ —µ«å∑¥≈Õß (In vivo) „™â µ√«®À“ “√‰æ‚√‡®π‰¥â∑ÿ°™π‘¥ 2. «‘∏’ Bacterial Endotoxin Test (LAL) ‡ªìπ°“√∑¥ Õ∫„π À≈Õ¥∑¥≈Õß (In vitro) ´÷Ëß„™â«‘∏’„¥«‘∏’Àπ÷Ë߇∑à“π—Èπ ·µàªí®®ÿ∫—πµ”√“¬“ ®–„™â«‘∏’ LAL ‡ªìπ à«π„À≠à‡æ◊ËÕÀ≈’°‡≈’ˬ߰“√„™â —µ«å∑¥≈Õß

Related substances 87 À¡“¬∂÷ß °“√µ√«®À“§«“¡∫√‘ ÿ∑∏‘Ï¢Õß “√ ‚¥¬µ√«®À“  “√Õ◊ËπÊ ∑’ˉ¡à„™à “√ÕÕ°ƒ∑∏‘Ï„πµ—«Õ¬à“ß ‡™àπ  “√ ≈“¬µ—«  “√ ªπ‡ªóôÕπ®“°°“√ —߇§√“–Àå “√ÕÕ°ƒ∑∏‘Ï¥—ß°≈à“« ‡ªìπµâπ Sterility test °“√µ√«® Õ∫°“√ªπ‡ªóôÕπ¢Õ߇™◊ÈÕ®ÿ≈‘π∑√’¬å„π‡¿ —™ º≈‘µ¿—≥±åª√“»®“°‡™◊ÈÕ ‡™à𠬓©’¥ ‡ªìπµâπ Uniformity of dosage units ¡’°“√∑¥ Õ∫‰¥â 2 ·∫∫ §◊Õ - Weight variation §◊Õ §à“‡∫’ˬ߇∫π®“°πÈ”Àπ—°‡©≈’ˬ - Uniformity of content À√◊Õ Content uniformity À¡“¬∂÷ß §«“¡ ¡Ë”‡ ¡Õ ¢Õߪ√‘¡“≥µ—«¬“„π·µà≈–Àπ૬ „π™à«ß∑’Ë°”À𥉫â Water content À¡“¬∂÷ß °“√µ√«®À“§«“¡™◊Èπ (Moisture) ‡æ◊ËÕ𔉪„™â„π °“√§”π«≥§«“¡·√ß À√◊Õª√‘¡“≥¢Õßµ—«¬“ ”§—≠

¥√√™π’ (INDEX) Àπâ“ 36 Aspirin tablet/enteric coated tablet 60 Atorvastatin film coated tablet 66 Albendazole tablet 14 Cefaclor capsule 15 Cefaclor suspension 16 Cefdinir capsule 17 Ceftazidime for injection 18 Cefuroxime for injection 19 Chloramphenical ear drop 20 Chloramphenical eye drop 21 Clindamycin injection 22 Co-trimoxazole oral suspension 30 Captopril tablet 56 Carbamazepine oral suspension 23 Dicloxacillin sodium capsule 37 Diclofenac diethylammonium gel 44 Domperidone oral suspension 45 Domperidone tablet 57 Diazepam tablet 67 Dexamethasone injection 68 Dexamethasone tablet 64 88 Fluconazole capsule 46 Hyoscine butylbromide coated tablet 31 Isosorbide dinitrate tablet 38 Ibuprofen tablet 62 Metformin HCI tablet 24 Norfloxacin tablet 32 Nifedipine solf capsule 33 Nifedipine extended release tablet 39 Naproxen sodium tablet 40 Naproxen tablet 25 Penicillin V potassium dry syrup

Penicillin V potassium tablet Àπâ“ Propranolol HCI film coated tablet 26 Phenytoin capsule 34 Propylthiouracil tablet 58 Roxithromycin tablet 69 Ranitidine tablet 27 Salbutamol inhaler 47 Tolperisone HCI tablet 50 Triprolidine HCI and Pseudoephedrine HCI tablet 41 Terbutaline sulfate injection 51 Terbutaline sulfate tablet 52 Timolol maleate eye drop 53 70 89

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