greenbook3

¬“√—°…“‚√§„π√–∫∫∑“߇¥‘πÕ“À“√ Dicyclomine HCL Syrup ‰¥‰´‚§≈¡’π ‰Œ‚¥√§≈Õ‰√¥å ™π‘¥‰´√—ª À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ ®Ÿ πå‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active Ingredient) - §“à §«“¡‡ªπì °√¥-‡∫  (pH) ººŸâ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ‚ª≈ø‘ “√¡å 2A 255/30 Berclomine Syrup Polipharm Co., Ltd. °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 4591

¬“√—°…“‚√§„π√–∫∫∑“߇¥‘πÕ“À“√ Loperamide HCL Capsule ‚≈‡æÕ√“‰¡¥å ‰Œ‚¥√§≈Õ‰√¥å ™π‘¥·§ª´Ÿ≈ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®π‡å Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active Ingredient) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µ≈à –Àπ«à ¬ (Content Uniformity) ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name π«‘ ‰≈øá ø“√å¡“ 1A 187/39 Dainox New Life Pharma Co., Ltd. Impelium ∑’.‚Õ.‡§¡’§Õ≈ å (1979) 1A 625/31 Loperamide T.O. Chemicals (1979) Co., Ltd. Õߧ尓√‡¿ ™— °√√¡ 1A 318/43 Government Pharm. Organization 502 GREEN BOOK 3

¬“√—°…“‚√§„π√–∫∫∑“߇¥‘πÕ“À“√ Metoclopramide HCL Injection ‡¡∑‚∑‚§≈æ√“‰¡¥å ‰Œ‚¥√§≈Õ‰√¥å ™π‘¥©¥’ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active Ingredient) - §“à §«“¡‡ªìπ°√¥-‡∫  (pH) - §«“¡ª√“»®“°‡™Õ◊È (Sterility Test) - Bacterial Endotoxin (LAL) ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ·Õ≈.∫.’ ‡Õ . ·≈∫∫Õ√“∑Õ√’ å 1A 1078/30 H-peran L.B.S. Laboratory Ltd., Part Vomitin π‘¥â“ ø“√å¡“ Õ‘π§Õ√ªå Õ‡√™πË— 1A 6/29 Nida Pharma Incorporation Metoclopramide Co., Ltd. Õߧ尓√‡¿ —™°√√¡ 1A 458/48 Government Pharm. Organization °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 513

¬“√°— …“‚√§„π√–∫∫∑“߇¥‘πÕ“À“√ Metoclopramide HCL Tablet ‡¡∑‚∑‚§≈æ√“‰¡¥å ‰Œ‚¥√§≈Õ‰√¥å ™π¥‘ ‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ πå‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active Ingredient) - §à“‡∫’ˬ߇∫π®“°π”È Àπ°— ‡©≈¬Ë’ (Weight Variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ººâŸ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ‚√ßß“π‡¿ —™°√√¡ ·Õµ·≈𵑰 1A 900/27 Maril Atlantic Laboratories Corp. Ltd. R-J ‡¡¥‘´π’ ‚ª√¥°—  å 1A 1969/29 Nausil Medicine Products Co., Ltd. Nausin  ¬“¡‡¿ —™ 1A 647/29 Siam Bheasach Co., Ltd. Metoclor ∑.’ ·¡π ø“√å¡“ 1A 927/27 T.Man Pharma Ltd. Part.  À·æ∑¬‡å ¿ —™ 1A 504/27 The Medic Pharma Co., Ltd. 524 GREEN BOOK 3

¬“√°— …“‚√§„π√–∫∫∑“߇¥‘πÕ“À“√ Sulfasalazine Tablet ´—≈ø“´“≈“´π’ ™π¥‘ ‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ ®Ÿ π‡å Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active Ingredient) - §à“‡∫¬Ë’ ߇∫π®“°πÈ”Àπ—°‡©≈¬’Ë (Weight Variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√‘¡“≥µ—«¬“„π·µà≈–Àπ૬ (Content Uniformity) ººâŸ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ‚√ßß“π‡¿ —™°√√¡ ·Õµ·≈𵑰 1A 1165/27 Saridine Atlantic Laboratories Corp. Ltd. Salazopyrin EN ø“√å¡“‡´’¬ ª√–‡∑» «’‡¥π 1C 192/39 Pharmacia AB, Sweden °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 535

¬“·°ªâ «¥ ≈¥‰¢â - Mefenamic acid Capsule 546 GREEN BOOK 3

¬“·°ªâ «¥ ≈¥‰¢â Mefenamic acid Capsule ¡‡’ øπ“¡‘§·Õ ‘¥ ™π¥‘ ·§ª´≈Ÿ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ ®Ÿ π‡å Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§—≠ (Active Ingredient) - §à“‡∫¬Ë’ ߇∫π®“°π”È Àπ°— ‡©≈’¬Ë (Weight Variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ‡°√∑ä ‡µÕ√å ø“√å¡“ 1A 288/46 Mefenan Greater Pharma Ltd. Part. Dismen  ¬“¡‡¡¥·‘ §√å 1A 1964/30 Siam Medicare Ltd. Anagic ∑.’ ·¡π ø“√å¡“ 1A 926/27 Panamic T.Man Pharma Ltd. Part. Mefenamic Acid ∑.’ ‚Õ.‡§¡’§Õ≈ å (1979) 1A 1186/31 T.O. Chemicals (1979) Co., Ltd. Õߧ尓√‡¿ ™— °√√¡ 1A 249/43 Government Pharm. Organization °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 557

¬“√—°…“‚√§„π√–∫∫∑“߇¥‘πÀ“¬„® - Guaifenesin Syrup - Guaifenesin Tablet 568 GREEN BOOK 3

¬“√—°…“‚√§„π√–∫∫∑“߇¥‘πÀ“¬„® Guaifenesin Syrup ‰°«‡øπ‡π´π‘ ™π¥‘ ‰´√—ª À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active Ingredient) - §“à §«“¡‡ªπì °√¥-‡∫  (pH) ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name Õߧ尓√‡¿ —™°√√¡ - Guaifenesin Syrup Government Pharm. Organization °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 579

¬“√—°…“‚√§„π√–∫∫∑“߇¥π‘ À“¬„® Guaifenesin Tablet ‰°«‡øπ‡π´‘π ™π‘¥‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®π‡å Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Active Ingredient) - §“à ‡∫¬’Ë ß‡∫π®“°π”È Àπ—°‡©≈¬Ë’ (Weight Variation) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) ººâŸ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ø“√å¡“ —πµå ·≈∫Á ∫Õ√“µÕ√ Ë’ å 1A 659/38 Glycolate Tablet Pharmasant Laboratories Co.,Ltd. Glycolate Tablet ∑.’ ·¡π ø“√å¡“ 1A 1944/29 T.Man Pharma Ltd. Part. 5680 GREEN BOOK 3

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ - Allopurinol Tablet - Amitriptyline HCl Tablet - Clomipramine HCl Tablet - Nortriptyline HCL Tablet - Probenecid Tablet - Selegiline HCl Tablet °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 5691

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ Allopurinol Tablet ·Õ≈‚≈‡æ¬’ «√‘πÕ≈ ™π¥‘ ‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®π‡å Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active Ingredient) - §à“‡∫’ˬ߇∫π®“°π”È Àπ—°‡©≈¬Ë’ (Weight Variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ººŸâ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name Õߧ°å “√‡¿ ™— °√√¡ 1A 256/45 Al opurinol Government Pharm. Organization Al opurinol ™¡ÿ ™π‡¿ —™°√√¡ 1A 77/32 Allopin Community Pharmacy Public Co.,Ltd. Alinol ‡¬π‡πÕ√å√“≈ ¥√—Í° å‡Œâ“ å 1A 641/28 Puride General Drugs House Co., Ltd. ø“√¡å “ —πµå ·≈∫Á ∫Õ√“µÕ√Ë ’ å 1A 622/32 Pharmasant Laboratories Co.,Ltd. ‚ª≈ø‘ “√¡å 1A 1461/28 Polipharm Co., Ltd. 602 GREEN BOOK 3

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ √“¬™Õ◊Ë ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name æÕπ¥å ‡§¡’§Õ≈ (ª√–‡∑»‰∑¬) 1A 287/33 Xandase-300 Pondûs Chemical (Thailand) R.O.P. Alomet ª√Ÿøøá 1A 576/31 Proof Co., Ltd. Al oric ∑.’ ‚Õ.‡§¡§’ Õ≈ å (1979) 1A 499/38 Purinol T.O. Chemicals (1979) Co., Ltd. 𑫉≈øá ø“√¡å “ 1A 147/39 New Life Pharma Co., Ltd. °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 613

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ Amitriptyline HCL Tablet Õ¡‘∑√‘æ∑‘≈π’ ‰Œ‚¥√§≈Õ‰√¥å ™π¥‘ ‡¡Á¥ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®π‡å Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Active Ingredient) - §à“‡∫’¬Ë ߇∫π®“°π”È Àπ—°‡©≈¬’Ë (Weight Variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - ª√¡‘ “≥ Related Substances ººâŸ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name Õߧ°å “√‡¿ —™°√√¡ 1A 119/45 Amitriptyline HCl 10 mg Government Pharm. Organization 1A 120/45 Amitriptyline HCl 25 mg ø“√¡å “ —πµå ·≈∫Á ∫Õ√“µÕ√’ Ë å 1A 200/35 Polytanol 25 Pharmasant Lab. Co.,Ltd. 1A 304/35 Polytanol 10 ‚ª≈ø‘ “√¡å 1A 786/43 Tripsyline 10 Polipharm Co., Ltd 624 GREEN BOOK 3

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ Clomipramine HCL Tablet ‚§≈¡æ‘ √“¡π’ ‰Œ‚¥√§≈Õ‰√¥å ™π¥‘ ‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Active Ingredient) - §à“‡∫’ˬ߇∫π®“°π”È Àπ—°‡©≈Ë’¬ (Weight Variation) - °“√·µ°µ«— ¢Õ߇¡Á¥¬“ (Disintegration) - ª√¡‘ “≥ Related Substances - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µà≈–Àπ«à ¬ (Content Uniformity) ººŸâ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name  À·æ∑¬‡å ¿ ™— 1A 826/40 Inaryl 25 The Medic Pharma Co., Ltd. °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 635

¬“√°— …“‚√§∑“ß√–∫∫ª√– “∑ Nortriptyline HCL Tablet πÕ√∑å √æ‘ ∑’≈’π ‰Œ‚¥√§≈Õ‰√¥å ™π¥‘ ‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ πå‡Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§≠— (Active Ingredient) - §“à ‡∫¬Ë’ ߇∫π®“°π”È Àπ°— ‡©≈¬Ë’ (Weight Variation: for film coated tablet) - °“√·µ°µ«— ¢Õ߇¡¥Á ¬“ (Disintegration) - ª√‘¡“≥ Related Substances ººâŸ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ‡Õ™. ≈π— ‡∫§ 1C 578 /30 Nortrilen 10 FCT H. Lundbeck A/S Co.,Ltd. 1C 579 /30 Nortrilen 25 FCT ø“√å¡“ —πµå ·≈∫Á ∫Õ√“µÕ√Ë ’ å 1A 430 /36 Ortrip 10 FCT Pharmasant Laboratories Co.,Ltd 1A 390 /36 Ortrip 25 FCT ¬‚Ÿ ∑‡ª¬ôï π 1A 1055 /30 Nortyline10 SCT Utopian Co., Ltd. 1A 1056 /30 Nortyline 25 SCT 1A 113 /35 Norline 25 SCT FCT = Film Coated Tablet SCT = Sugar Coated Tablet 646 GREEN BOOK 3

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ Probenecid Tablet ‚ª√‡∫π‡π ¥‘ ™π‘¥‡¡Á¥ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active Ingredient) - §“à ‡∫¬’Ë ß‡∫π®“°π”È Àπ—°‡©≈’ˬ (Weight Variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ¬‚Ÿ ∑‡ª¬ôï π 1A 1136/27 Bencid Utopian Co., Ltd. °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 657

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ Selegiline HCl Tablet ‡´‡≈®‘≈’π ™π‘¥‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®π‡å Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§≠— (Active Ingredient) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ—«¬“„π·µà≈–Àπ«à ¬ (Content Uniformity) - ª√‘¡“≥ Related Substances ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ‰∫‚Õ·≈∫ 1A 235/35 Julab Biolab Co., Ltd. 668 GREEN BOOK 3

°√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 69

¬“™“ - Lidocaine HCl Injection 7680 GREEN BOOK 3

¬“™“ Lidocaine HCL Injection ≈‚‘ ¥‡§π ‰Œ‚¥√§≈Õ‰√¥å ™π‘¥©’¥ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ πå‡Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active Ingredient) - §“à §«“¡‡ªìπ°√¥-‡∫  (pH) - °“√µ√«® Õ∫§«“¡ª√“»®“°‡™Õ◊È (Sterility Test) - Bacterial Endotoxin (LAL) ººâŸ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ·Õ≈.∫.’ ‡Õ . ·≈∫∫Õ√“∑Õ√’ å 1A 132/28 Locana L.B.S. Laboratory Ltd., Part Docaine 2% ‡Õ¡Á ·Õπ¥å ‡Õ™Á ·¡πŸ·ø§‡®Õ√ßË‘ 1A 692/34 M & H Manufacturing Co., Ltd. LD-Caine 1% ¡≈‘ ≈‡‘ ¡¥ 1A 243/47 Xylocaine 2% Millimed Co.,Ltd. Lidocaine HCl ‚Õ≈§‘ (ª√–‡∑»‰∑¬) 1A 722/28 Olic (Thailand) Ltd. Õߧ°å “√‡¿ ™— °√√¡ - Government Pharm. Organization °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 697°√1¡

¬“µ“â π‡™◊ÕÈ ¡“‡≈‡√’¬ - Chloroquine phosphate Tablet 702 GREEN BOOK 3

¬“µ“â π‡™Õ◊È ¡“‡≈‡√¬’ Chloroquine Phosphate Tablet §≈Õ‚√§«‘π øÕ ‡øµ ™π‘¥‡¡Á¥ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§—≠ (Active Ingredient) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - §à“‡∫ˬ’ ߇∫π®“°πÈ”Àπ°— ‡©≈Ë’¬ (Weight Variation) ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ‡Õ.‡ÕÁπ.∫.’ ≈“∫Õ√“µÕ√Ë’ 1A 2040/28 Malacin Chloroquine A.N.B. Laboratories Co., Ltd. Diroquine Chloroquine ‡Õ‡™¬’Ë πø“√¡å “´Ÿµ‘§Õ≈ 1A 1112/30 Maliaquine Nitaquine Asian Pharmaceutical Ltd. Part. Chloroquine ‚√ßß“π‡¿ —™°√√¡ ·Õµ·≈πµ°‘ 1A 932/28 Atlantic Laboratories Corp. Ltd. ∫√Ÿ æ“‚Õ ∂ 1A 1632/30 Burapha Osoth Co., Ltd. ‡¿ ™— °√√¡»√ª’ √– ∑‘ ∏‘Ï 1A 95/28 Sriprasit Pharma Co.,Ltd. ¬‚Ÿ ∑‡ª¬ïô π 1A 59/30 Utopian Co., Ltd. Õߧ°å “√‡¿ ™— °√√¡ 1A 232/45 Government Pharm. Organization °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 713

¬“µ“â π‡™ÈÕ◊ ‰«√—  - Zidovudine Capsule 724 GREEN BOOK 3

¬“µâ“π‡™ÕÈ◊ ‰«√—  Zidovudine Capsule ´‘‚¥«¥Ÿ ’π ™π¥‘ ·§ª´≈Ÿ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®‡Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Assay) - §“à ‡∫¬Ë’ ߇∫π®“°π”È Àπ—°‡©≈¬Ë’ (Weight Variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - ª√‘¡“≥ Related Substances ººŸâ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name Õߧ°å “√‡¿ ™— °√√¡ 1A 298/45 Antivir 100 mg Government Pharm. Organization Retrovir 250 mg ·°≈°Á ‚´ ‡«≈§—¡ ª√–‡∑»Õß— °ƒ… 1C 96 /46 T.O Vir 100 mg Glaxo Wellcome Operation, UK ∑.’ ‚Õ ‡§¡’§Õ≈ å (1979) 1A 500/38 T.O Chemicals (1979) Ltd. ß∫ª√–¡“≥ :  ”π—°ß“πÀ≈—°ª√–°π—  ÿ¢¿“æ·Ààß™“µ‘ °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 75

¬“√—°…“‚√§‡∫“À«“π - Insulin Injection 746 GREEN BOOK 3

¬“ª√–‡¿∑Õπ◊Ë Ê Insulin Injection Õ‘π´Ÿ≈‘π ™π‘¥©’¥ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ ®Ÿ π‡å Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Active Ingredient) - §à“§«“¡‡ªìπ°√¥-‡∫  (pH) - §«“¡ª√“»®“°‡™ÕÈ◊ (Sterility Test) - Bacterial Endotoxin (LAL) ººŸâ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ≈≈‘ ≈’Ë ª√–‡∑»Ω√ßË— ‡»  1C 105/42N Humalog Mix Lilly France S.A.S., France 1C 168/44 Humulin 70/30 ≈‘≈≈’Ë ø“√¡å “ 1C 387/40 Humulin-N Lilly Pharma Fertigung 1C 388/40 Humulin-R 2C 39/39 Mixtard ‚π‚« πÕ√奠‘ §å ª√–‡∑»‡¥π¡“√å§ Novo Nordisk A/S, Denmark 1C 140/39 Insulatard HM ‚Õ≈§‘ (ª√–‡∑»‰∑¬) Olic (Thailand) Ltd. °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 757

¬“ª√–‡¿∑Õπ◊Ë Ê - Levonorgestrel and Ethinyl estradiol Tablet - Peritoneal dialysis Solution - Sodium chloride Injection 768 GREEN BOOK 3

¬“ª√–‡¿∑Õπ◊Ë Ê Levonorgestrel and Ethinyl estradiol Tablet ≈‚’ «πÕ√凮 ‡∑√≈·≈–‡Õ∑π‘ ‘≈‡Õ µ√“‰¥‚Õ≈ ™π¥‘ ‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Active Ingredient) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√‘¡“≥µ—«¬“„π·µ≈à –Àπ«à ¬ (Content Uniformity) ººŸâ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ‰∫‚Õ·≈∫ 2A 106/35 Riget 21+7 Biolab Co., Ltd. Microlenyn 30 ED æÕπ¥å‡§¡’§Õ≈ (ª√–‡∑»‰∑¬) 2A 73/34 Pondûs Chemical (Thailand) R.O.P. Microgest ED æ’ ∑’ ‡™Õ√‘ßË ª√–‡∑»Õ‘π‚¥π‡’ ´¬’ 2C 128/40 R-Den P.T. Schering, Indonesia ‰∑¬π§√æ≤— π“ 2A 172/34 Thai Nakorn Pattana Co., Ltd. °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 779

¬“ª√–‡¿∑ÕπË◊ Ê Peritoneal dialysis Solution π”È ¬“≈“â ߉µ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - Bacterial Endotoxin (LAL) ººŸâ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ‡Õ.‡ÕÁπ.∫.’ ≈“∫Õ√“µÕ√’Ë 2A 58/33 P.D.S. +1.5% D A.N.B. Laboratories Co., Ltd. Haemo-A Õ‘ÕÕπ‡¡¥ - Dialyte A Aeonmed Co.,Ltd Inpersolution 1.5% CAPD/DPCA 10 ‡¬‡πÕ√≈— ŒÕ ªîµ≈— ‚ª√¥—§ å 2A 31/29 with 1.5% GL General Hostital Products Co., Ltd. 2A 804/30 PTD sol. Peritoneal ‰∑¬π§√æ≤— π“ 2A 128/44 dialysis Peri Solution A Thai Nakorn Pattana Co., Ltd. 2A 527/31 ‰∑¬ ‚Õ´Ÿ°“â 2A 116/28 Thai Otsuka Pharmaceutical Co., Ltd. 7880 GREEN BOOK 3

¬“ª√–‡¿∑ÕπË◊ Ê Sodium Chloride Injection ‚´‡¥¬’Ë ¡§≈Õ‰√¥å ™π‘¥©¥’ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Active Ingredient) - §“à §«“¡‡ªπì °√¥-‡∫  (pH) - °“√µ√«® Õ∫§«“¡ª√“»®“°‡™◊ÕÈ (Sterility Test) - Bacterial Endotoxin (LAL) ººâŸ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ‡Õ.‡ÕÁπ.∫.’ ≈“∫Õ√“µÕ√Ë’ 1A 424/28 NSS A.N.B. Laboratories Co., Ltd. NSS ‡¬‡πÕ√≈— ŒÕ ªµî ≈— ‚ª√¥§—  å 1A 1393/29 NSS General Hospital Products Co., Ltd. N-S-S ‰∑¬π§√æ—≤π“ 1A 1427/30 Thai Nakorn Pattana Co., Ltd. ‰∑¬ ‚Õ´Ÿ°“â 1A 658/30 Thai Otsuka Pharmaceutical Co., Ltd. °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 8791

82 GREEN BOOK 3

¿“§ºπ«° ¿“§ºπ«° ¿“§ºπ«° °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 83

 “√¡“µ√∞“𬓷≈–«µ— ∂‡ÿ  æµ¥‘  “√¡“µ√∞“𬓷≈–«—µ∂ÿ‡ æµ‘¥¡’§«“¡ ”§—≠·≈–®”‡ªìπÕ¬à“߬‘Ëß „πß“π§«∫§¡ÿ §ÿ≥¿“櫵— ∂ÿ¥∫‘ ‡¿ —™¿—≥±å «—µ∂Õÿ Õ°ƒ∑∏‘Ï ·≈–°“√µ√«®æ‘ ®Ÿ πå ¬“‡ æµ¥‘ ∑ßÈ— ‚¥¬«∏‘ ∑’ “߇§¡·’ ≈–®≈ÿ ™«’ «∑‘ ¬“µ“¡¢Õâ °”À𥵓à ßʇ™πà °“√µ√«® æ‘ ®Ÿ πå‡Õ°≈—°…≥å °“√µ√«®À“ª√‘¡“≥ “√ ”§≠—  “√ªπ‡ªôÕó π ·≈– “√ ≈“µ—« ‡ªìπµâπ ´Ë÷ß “√¡“µ√∞“π∂◊Õ‡ªìπªí®®—¬À≈—°„π°“√ª√–°—π§ÿ≥¿“欓·≈–«—µ∂ÿ µ”√—∫∑—Èß„π‚§√ß°“√ √â“ßÀ≈—°ª√–°—π§ÿ≥¿“æ·≈–¡“µ√∞“π∫√‘°“√¥â“π¬“¢Õß °√–∑√«ß “∏“√≥ ¢ÿ ·≈–°“√°”°∫— ¥·Ÿ ≈°“√π”‡¢“â «µ— ∂¥ÿ ∫‘ ‡¿ ™— ‡§¡¿’ ≥— ±å ·≈– ‡¿ —™¿≥— ±å®“°µ“à ߪ√–‡∑»¢Õß ”π°— ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“ µ—Èß·µàªï æ.». 2525 °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å‚¥¬°Õß«‘‡§√“–À嬓 (™Ë◊Õ„π¢≥–πÈ—π) ‰¥â‡√Ë‘¡µâπ‚§√ß°“√®—¥∑” “√¡“µ√∞“πÕ“‡´’¬π (ASEAN Reference Substances, ARS) ‚¥¬‰¥â√—∫°“√ π—∫ πÿπ∑—Èߥâ“π°“√‡ß‘π·≈– ¥â“π«‘™“°“√®“°Õߧ尓√Õπ“¡—¬‚≈° ¿“¬„µâ§«“¡√à«¡¡◊Õ∑“߇¿ —™°√√¡¢Õß  ¡“™°‘ °≈¡ÿà ª√–‡∑»Õ“‡´’¬π ‰¥·â °à Õπ‘ ‚¥π‡’ ´’¬ ¡“‡≈‡´¬’ ø≈î ‘ªªîπ å  ß‘ §‚ª√å ·≈–ª√–‡∑»‰∑¬ ‚¥¬ª√–‡∑» ¡“™‘°¥—ß°≈à“«√à«¡¡◊Õ°—𥔇π‘π°“√º≈‘µ “√ ¡“µ√∞“πµ“¡·π«ªØ‘∫µ— ‘¢ÕßÕߧ尓√Õπ“¡¬— ‚≈° (WHO General Guideline for the Establishment, Maintenance and Distribution of Chemical Reference Substances; 1996) ·≈–µ“¡§”·π–π”¢ÕߺŸâ‡™Ë’¬«™“≠¢Õß Õߧ°å “√Õπ“¡¬— ‚≈° ª®í ®∫ÿ π— ¡ª’ √–‡∑» ¡“™°‘ ‡æ¡Ë‘ ¢π÷È Õ°’ 4 ª√–‡∑»§Õ◊ ‡«¬’ µπ“¡ °—¡æŸ™“ ≈“« ·≈–‡¡¬’ π¡“√å À≈ß— ®“°ªï æ.». 2535 ‡ªìπµπâ ¡“‰¥â¡°’ “√‡ª≈¬’Ë π ºŸâ π—∫ πÿπ®“°Õߧ尓√Õπ“¡—¬‚≈°‡ªìπ Japan Pharmaceutical Manu- facturers Association (JPMA) ‡π◊ËÕß®“°§«“¡µâÕß°“√„™â “√¡“µ√∞“π„πÀâÕߪؑ∫—µ‘°“√§«∫§ÿ¡ §≥ÿ ¿“欓‡æ¡Ë‘ ¡“°¢÷πÈ „πªï æ.». 2536 °Õ߬“ (™◊ÕË „π¢≥–πÈ—π) ‰¥‡â æ‘Ë¡°“√ º≈‘µ “√¡“µ√∞“π¢πÈ÷ Õ’°™Õà ß∑“ßÀπß÷Ë §Õ◊  “√¡“µ√∞“π¢Õß°√¡«∑‘ ¬“»“ µ√å 824 GREEN BOOK 3

°“√·æ∑¬å (DMSC Reference Standards, DMScRS) ´ß÷Ë ¡¡’ “µ√∞“π°“√º≈µ‘ ‡™àπ‡¥’¬«°—∫ “√¡“µ√∞“πÕ“‡´’¬π ·≈–¡’∫√‘°“√®”Àπà“¬„Àâ·°àºâŸº≈‘µ¬“„π ¿“§Õµÿ  “À°√√¡º≈‘µ¬“ „π√“§“µ”Ë °«à“´È◊Õ®“°µà“ߪ√–‡∑» „πªï æ.». 2550  ”π°— ¬“·≈–«—µ∂ÿ‡ æµ¥‘ (™ËÕ◊ „πª®í ®ÿ∫—π) ‰¥æâ ≤— π“ °“√º≈‘µ “√¡“µ√∞“π„À‡â ªìπ‰ªµ“¡√–∫∫§≥ÿ ¿“æ ISO Guide 34 (General Requirements for the Competence of Reference Material Producers) ´÷Ëß„π√–∫∫§ÿ≥¿“æ ISO  ”À√—∫ÀâÕߪؑ∫—µ‘°“√ ‡™àπ ISO 17025 : 2005 °”Àπ¥„À„â ™«â  — ¥ÿÕ“â ßÕß‘ ∑‰Ë’ ¥√â ∫— °“√√∫— √Õß (Certified Reference Materials, CRM) À√◊Õ‡√’¬°Õ’°™◊ËÕÀπ÷Ëß«à“ «— ¥ÿ¡“µ√∞“πÕâ“ßÕ‘ß (Standard Reference Materials,SRM) ´Ë÷ßÀ¡“¬∂÷ß«— ¥ÿÕâ“ßÕ‘ß∑’Ë¡’°“√°”Àπ¥§ÿ≥ ¡∫—µ‘ÀπË÷ß§à“ À√◊Õ¡“°°«à“ ‚¥¬«‘∏’°“√∑’Ë„À≥⡓´÷Ëß§à“¥—ß°≈à“« “¡“√∂ Õ∫°≈—∫‰ª¬—ß Àπ૬«—¥πÈ—πÊ (SI unit) ‚¥¬·µà≈–§à“∑Ë’√“¬ß“πµâÕß√–∫ÿ§à“§«“¡‰¡à·πàπÕπ (Uncertainty) ∑√Ë’ –¥∫— §«“¡‡™◊ÕË ¡Ë—πÀπËß÷ ‡¡◊ËÕ°“√º≈‘µ “√¡“µ√∞“π‰¥â√—∫°“√æ—≤𓵓¡√–∫∫§ÿ≥¿“æ “°≈ ∂÷ß√–¥—∫«— ¥¡ÿ “µ√∞“πÕâ“ßÕ‘ß (CRM) ·≈«â ®–¡°’ “√®¥— √–∫∫°“√∂“à ¬§à“°“√«—¥ ‰ª àŸÀâÕߪؑ∫—µ‘°“√Õ◊ËπÊ¥â“π°“√µ√«®«‘‡§√“–Àå§ÿ≥¿“欓·≈–«—µ∂ÿ‡ æµ‘¥ ‡™πà „π‚√ßß“πº≈µ‘ ¬“ ∑”„À‡â °¥‘ °“√∑«π Õ∫§à“°“√«¥— (traceability) °≈—∫ Ÿà ¡“µ√∞“𙓵‘‰¥â‚¥¬‰¡à¢“¥µÕπ π—∫«à“‡ªìπ°“√æ—≤π“·≈–¬°√–¥—∫ß“π¥â“π ª√–°π— §≥ÿ ¿“欓·≈–«µ— ∂‡ÿ  æµ¥‘ ¢Õߪ√–‡∑» Õπ— ®– ßà º≈„À‡â °¥‘  ¢ÿ Õπ“¡¬— ∑¥Ë’ ’ ·°ªà √–™“™πµàÕ‰ª  “√¡“µ√∞“πÕ“‡´¬’ π ·≈– “√¡“µ√∞“π¢Õß°√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å  “¡“√∂´ÈÕ◊ ‰¥â∑’Ë  ”π°— ¬“·≈–«—µ∂ÿ‡ æµ¥‘ ‚∑√ 0-2951-0000 µÕà 99102, 99103 À√Õ◊ µ√«® Õ∫√“¬™Õ◊Ë  “√¡“µ√∞“π∑Ë¡’ ’®”Àπ“à ¬‰¥â∑’Ë http://webdb.dmsc.moph.go.th/ifc_drug ·≈– www.aseanrs.org °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 835

°“√ —߇°µº≈‘µ¿≥— ±å¬“‡æ◊ËÕ∫ßà ™’§È «“¡‰¡à§ß ¿“æ (Observing products for evidence of instability) °“√ ≠Ÿ ‡ ¬’ §«“¡·√ߢÕßµ«— ¬“ ”§≠— ¡°— ®–‡ªπì º≈¡“®“°°“√‡ª≈¬’Ë π·ª≈ß ∑“߇§¡’ ‚¥¬ªØ‘°‘√‘¬“∑’Ëæ∫¡“°∑’Ë ÿ¥§◊Õ °“√·¬° ≈“¬¥â«¬π”È (hydrolysis) °“√‡°¥‘ ÕÕ°´‡‘ ¥™π— -√¥’ °— ™π— (oxidation-reduction) ·≈–°“√·¬° ≈“¬¥«â ¬· ß (photolysis) πÕ°®“°πÈ’°“√‡ª≈Ë’¬π·ª≈ß∑“߇§¡’¬—ßÕ“®‡°‘¥¢÷Èπ ®“°°“√∑” ªØ‘°‘√‘¬“°—π√–À«à“ß à«πº ¡µà“ßÊ„πº≈‘µ¿—≥±å¬“ À√◊Õ∫“ߧ√È—ß√–À«à“ßµ—« º≈µ‘ ¿≥— ±‡å Õß°∫— ¿“™π–∫√√®ÿ °“√ ≠Ÿ ‡ ¬’ §«“¡·√ߢÕßµ«— ¬“ ”§≠— ∑ ’Ë ß— ‡°µ‰¥â Õ“®‡°‘¥®“° °“√·æ√à¢Õ߬“‡¢â“‰ª„π¿“™π–∫√√®ÿ À√◊Õ°“√√«¡µ—«¢Õ߬“°—∫ æÈ◊πº‘«¢Õß¿“™π–∫√√®ÿ  à«π°“√‡æË‘¡¢È÷π¢Õߧ«“¡·√ßπÈ—π¡—°®–‡ªìπº≈¡“®“° °“√√–‡À¬¢Õßµ—«∑”≈–≈“¬À√Õ◊ °“√≈–≈“¬¢Õß “√®“°«— ¥¢ÿ Õß¿“™π–∫√√®ÿ §«“¡·√ß∑“߇§¡’¢Õßµ—«¬“ ”§—≠ ®–µâÕߧßÕ¬àŸ¿“¬„π≈‘¡‘µ (limit) √–¥∫— ∑°’Ë ”À𥉫‡â ªπì ¡“µ√∞“𧫓¡·√ߢÕßµ«— ¬“∑√“∫‰¥‚â ¥¬«∏‘ µ’ √«®«‡‘ §√“–Àå ´ß÷Ë  “¡“√∂·¬°§«“¡·µ°µ“à ß√–À«à“ß‚¡‡≈°≈ÿ  ¿“æª√°µ‘ (intact molecule) ·≈– “√ ≈“¬µ—«¢Õß¡—π ∑—ÈßπÈ’ºâŸº≈‘µ§«√®–¡’¢âÕ¡Ÿ≈‡°’ˬ«°—∫§«“¡§ß ¿“æ∑“ß ‡§¡’¢Õßµ—«¬“ ”§—≠ ∂÷ß·¡â«à“‚¥¬∑Ë—«‰ª‡¿ —™°√ºŸâ®à“¬¬“‰¡à “¡“√∂µ√«® Õ∫ °“√‡ Ë◊Õ¡∑“߇§¡’¢Õßµ—«¬“‰¥â ·µà°“√‡ Ë◊Õ¡∑“߇§¡’Õ¬à“ß¡“°®–∑”„À⇰‘¥ §«“¡‡ª≈¬’Ë π·ª≈ß∑“ß°“¬¿“æ∑ ’Ë ß— ‡°µ‡ÀπÁ ‰¥â πÕ°®“°π’È °“√‡ª≈¬’Ë π·ª≈ß∑“ß °“¬¿“æ∫“ߪ√–°“√Õ“®‰¡à‡°Ë’¬«¢âÕß°—∫§«“¡·√ß∑“߇§¡’ ‡™àπ °“√‡ª≈’Ë¬π ’ ·≈–°≈πË‘ √ªŸ ≈—°…≥¢å Õßµ–°Õπ À√Õ◊ °“√∑’ Ë “√≈–≈“¬¡’§«“¡¢àπÿ ·µ à ‘Ë߇À≈“à πÈ’ Õ“®‡ªìπ —≠≠“≥‡µ◊Õπ„À⇿ —™°√µ√–Àπ—°∂÷ߧ«“¡‡ªìπ‰ª‰¥â∑Ë’®–‡°‘¥ªí≠À“ ‡°Ë’¬«°—∫§«“¡‰¡à§ß ¿“æ ∑È—ßπ’È Õ“®µ—Èß ¡¡µ‘∞“π‰¥â«à“ º≈‘µ¿—≥±å∑’Ë¡’°“√ 846 GREEN BOOK 3

‡ª≈¬Ë’ π·ª≈ß∑“ß°“¬¿“æ ∑‰Ë’ ¡‰à ¥·â ®ßâ ‡µÕ◊ π‰«„â π©≈“° Õ“®®–¡°’ “√‡ª≈¬’Ë π·ª≈ß ∑“߇§¡¥’ «â ¬ ·≈–º≈µ‘ ¿—≥±å¥—ß°≈à“«‰¡§à «√®–π”¡“„™âÕ°’ °“√‡®√≠‘ ‡µ∫‘ ‚µ¢Õß ®≈ÿ ™æ’ ∑¡’Ë “°‡°π‘ ‰ª °“√ªπ‡ªÕôó π À√Õ◊ ∑ß—È  ÕßÕ¬“à ß Õ“®∑”„À‡â °¥‘ °“√‡ª≈¬Ë’ π·ª≈ß ∑“ß°“¬¿“æ °“√‡ª≈’ˬπ·ª≈ß∑“ß°“¬¿“æÕ◊ËπÊ ∑’Ëæ∫∫àÕ¬·≈–Õ“®∫àß∫Õ°∂÷ß°“√ ‡ ËÕ◊ ¡¢Õ߬“‡µ√¬’ ¡·µ≈à –√Ÿª·∫∫ ¡’√“¬≈–‡Õ¬’ ¥¥—ßπ’È 1. √Ÿª·∫∫¬“¢Õß·¢Áß (Solid dosage forms) √Ÿª·∫∫¬“¢Õß·¢Áß À≈“¬ª√–‡¿∑‰¥â√—∫°“√ÕÕ°·∫∫¡“‡æ◊ËÕ°“√‡°Á∫√—°…“„π ¿“«–∑Ë’¡’§«“¡™È◊πµË” ®÷ßµÕâ ߉¥â√—∫°“√ª°ªÕÑ ß®“°πÈ”„π ‘Ëß·«¥≈âÕ¡ ©–ππ—È ®÷ßµâÕ߇°∫Á √—°…“„π¿“™π– ∫√√®ÿ∑Ë’ªî¥·πàπ À√◊Õ„π¿“™π–∫√√®ÿ‡¥‘¡¢ÕߺŸâº≈‘µ °“√¢àÿπ¡—« (fog) À√◊Õ¡’ À¬¥πÈ”À√◊Õ°“√‡°“–µ—«°—π¢Õ߬“¿“¬„π¿“™π–∫√√®ÿ ∫àß∫Õ°∂÷ß ¿“«–∑’ˉ¡à ‡À¡“– ¡ °“√„ à “√¥¥Ÿ §«“¡™π◊È ¿“¬„π¿“™π–∫√√®ÿ ∑º’Ë ºâŸ ≈µ‘ ∫√√®ÿ‰«â · ¥ß«“à §«√„ „à ®„π°“√®à“¬¬“ππÈ— ‡ªìπ摇»…  “√ ≈“¬µ—«∫“ߪ√–‡¿∑ ‡™πà °√¥´“≈‘- ‰´≈‘§®“°·Õ ‰æ√‘π Õ“®¡’°“√√–‡À‘¥·≈–µ°º≈÷°¿“¬πÕ°‡¡Á¥¬“À√◊Õµ‘¥∫π ºπß— ¢Õß¿“™π–∫√√®ÿ 1.1 ·§ª´≈Ÿ ‡®≈“µ‘π·¢ßÁ À√◊Õπÿà¡ (Hard or solf gelatin capsules) ‡πË◊Õß®“°¬“®–∂Ÿ°∫√√®ÿÕ¬àŸ„π·§ª´Ÿ≈∑Ë’∑”®“°‡®≈“µ‘π °“√‡ª≈Ë’¬π·ª≈ß‚¥¬ √«¡∑“ß°“¬¿“æÀ√Õ◊ §«“¡‰¡ à ¡Ë”‡ ¡Õ √«¡∂÷ß °“√·¢ßÁ µ—«À√◊ÕÕàÕπµ—«≈ߢÕß ‡ª≈◊Õ°·§ª´Ÿ≈ ‡ªìπ Ë‘ß∫àß∫Õ°‡∫◊ÈÕßµâπ¢Õߧ«“¡‰¡à§ß ¿“æ Õ’° —≠≠“≥ÀπË÷ß ¢Õߧ«“¡‰¡à§ß ¿“æ§◊Õ √àÕß√Õ¬°“√ª≈àÕ¬°ä“´ ´Ë÷ß —߇°µ‰¥â®“°°√–¥“…Àÿâ¡ ‡°‘¥°“√¬◊¥µ—« 1.2 ¬“‡¡¥Á ‰¡à‡§≈Õ◊ ∫ (Plain tablets) °“√‡ª≈ˬ’ π·ª≈ß∑“ß°“¬¿“æ ¢Õ߬“‡¡Á¥‰¡à‡§≈◊Õ∫Õ“®· ¥ß„Àâ‡ÀÁπ‰¥â®“°°“√¡’ºßÀ√◊ՙȑπ‡≈Á°Ê‡°‘¥¢÷Èπ¡“° °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 857

°“√ —߇°µº≈µ‘ ¿≥— ±¬å “‡æ◊ÕË ∫ßà ™’§È «“¡‰¡§à ß ¿“æ (‡™àπ °“√°√àÕπ ´Ë÷߉¡à„™à°“√·µ°À—°) √Õ¬·µ°À√◊Õ√Õ¬∫Ë‘π∫πº‘«¢Õ߇¡Á¥¬“ °“√∫«¡ ¡’®ÿ¥°√– °“√‡ª≈’Ë¬π ’ °“√‡°“–µ‘¥°—π¢Õ߇¡Á¥¬“ À√◊Õ°“√µ°º≈÷° ∫πºπß— ¿“™π–∫√√®Àÿ √◊Õ∫𵫗 ‡¡Á¥¬“ 1.3 ¬“‡¡Á¥‡§≈◊Õ∫ (Coated tablets) §«“¡‰¡à§ß ¿“æ¢Õ߬“ ‡¡Á¥‡§≈◊Õ∫ Õ“®¥Ÿ‰¥â®“°√Õ¬·µ° ¡’®ÿ¥°√– À√◊Õ§«“¡‡ÀπÕ–¢Õß«— ¥ÿ‡§≈◊Õ∫ ·≈–°“√‡°“–µ«— °—π¢Õ߇¡Á¥¬“ 1.4 ºß·ÀâßÀ√◊Õ·°√πŸ≈ (Dry powders and granules) ºß·Àâß À√Õ◊ ·°√π≈Ÿ ∑‰’Ë ¡‰à ¥‡â ®“–®ß‡æÕË◊ ‡µ√¬’ ¡‡ªπì ¬“™π¥‘ ‡À≈«·≈–Õ¬„Ÿà π¿“™π–∫√√®‡ÿ ¥¡‘ Õ“®·¢ßÁ µ—«‡ªπì °âÕπ·¢ßÁ À√◊Õ‡ª≈ˬ’ π ’ ´÷ßË Õ“®∑”„Àπâ ”‰ª„™â‰¡‰à ¥â 1.5 ¬“ºß·≈–·°√πŸ≈∑Ë’‡®“–®ß‡æË◊Õ‡µ√’¬¡‡ªìπ¬“πÈ”·¢«πµ–°Õπ (Powders and granules intended for constitution as suspension)  ”À√—∫ºß·Àâß·≈–·°√πŸ≈∑Ë’‡®“–®ß‡æË◊Õ°“√‡µ√’¬¡‡ªìπ “√≈–≈“¬À√◊Õ¬“π”È ·¢«πµ–°Õπ µÕâ ß„ „à ®‡ªπì 懑 »… ª°µ¬‘ “„π√ªŸ ·∫∫¥ß— °≈“à «¡°— ®–‡ªπì ¬“ªØ™‘ «’ π– À√◊Õ«‘µ“¡‘π∑Ë’¡’§«“¡‰«µàÕ§«“¡™È◊π ‡π◊ËÕß®“°¬“‡À≈à“π’È¡—°®–∂Ÿ°‡µ√’¬¡·≈– „™„â π¿“™π–∫√√®‡ÿ ¥¡‘ ®ß÷ ‰¡‡à °¥‘ º≈°√–∑∫®“°§«“¡™π◊È Õ¬“à ߉√°¥Á ’ À“°ª√“°Ø «à“ ¬“·¢Áßµ«— ‡ªìπ°âÕπ°Á§«√®–¡’°“√ª√–‡¡π‘ Õ¬à“ß√Õ∫§Õ∫ °“√‡°‘¥À¡Õ°À√Õ◊ À¬¥π”È ¿“¬„π¿“™π–∫√√®®ÿ –∑”„À¬â “‡µ√¬’ ¡‰¡‡à À¡“–·°°à “√𔉪„™â πÕ°®“°π’È °“√¡°’ ≈π‘Ë ∑’‰Ë ¡àæ÷ߪ√– ß§å°Á‡ªπì µ—«∫àß∫Õ°§«“¡‰¡à§ß ¿“懙πà °—π 1.6 ‡¡Á¥¬“ ·°√πŸ≈ ·≈–ºß ™π‘¥øÕßøÉŸ (Effervescent tablets, granules and powders) º≈‘µ¿—≥±å∑Ë’‡°‘¥øÕßøŸÉ¡—°¡’§«“¡‰«µàÕ§«“¡™◊Èπ ¡“°‡ªπì 摇»… °“√∫«¡¢Õß¡«≈ À√◊Õ °“√‡°¥‘ §«“¡¥π— Õ“°“» ‡ªπì  ‘ßË ∫àß∫Õ° §«“¡‰¡à§ß ¿“æ«à“ °“√‡°‘¥øÕßøÉŸ ‰¥‡â °¥‘ ¢È÷π‡√Á«°«“à °”Àπ¥ 2. √ªŸ ·∫∫¬“‡À≈« (Liquid dosage forms)  ßË‘  ”§≠— ∑’Ë ¥ÿ  ”À√—∫ 868 GREEN BOOK 3

°“√ —߇°µº≈µ‘ ¿≥— ±¬å “‡æÕË◊ ∫àß™’ȧ«“¡‰¡à§ß ¿“æ √Ÿª·∫∫¬“‡À≈« °Á§◊Õ §«“¡‡ªìπ‡π◊ÈÕ‡¥’¬«°—π·≈–°“√ª√“»®“°°“√ªπ‡ªóôÕπ ·≈–°“√‡®√‘≠‡µ‘∫‚µ¢Õß®ÿ≈™’æ §«“¡‰¡à§ß ¿“æÕ“®∫àß∫Õ°‰¥â®“° §«“¡¢ÿàπ À√Õ◊ °“√µ°µ–°Õπ„π “√≈–≈“¬ °“√·µ°µ«— ¢ÕßÕ¡‘ ≈— ™π— °“√·¢ßÁ µ«— „π≈°— …≥– ‡ªìπ°âÕπ·¢Á߉¡à “¡“√∂Õ¬Ÿà„π ¿“æ·¢«πµ–°Õπ‰¥â À√◊Õ°“√‡ª≈Ë’¬π·ª≈ß ∑“ߥâ“π°≈Ë‘π √  ¢Õ߬“ °“√‡®√‘≠‡µ‘∫‚µ¢Õß®ÿ≈™’æ¡—°®–‡°‘¥¢÷Èπæ√âÕ¡°—∫ °“√‡ª≈¬’Ë π ’ §«“¡¢àπÿ À√Õ◊ °“√‡°¥‘ °ä“´ 2.1  “√≈–≈“¬ ¬“Õ‘≈‘°‡´Õ√å ·≈–¬“πÈ”‡™Ë◊Õ¡ (Solution, elixers and syrup) °“√µ°µ–°Õπ·≈–√àÕß√Õ¬°“√‡°‘¥®ÿ≈™’æÀ√◊Õ°ä“´‡ªìπÕ“°“√ À≈—°∑·’Ë  ¥ß∂÷ߧ«“¡‰¡§à ß ¿“æ 2.2 ¬“Õ‘¡—≈™—π (Emulsion) Õ“°“√∑’Ë· ¥ß∂÷ߧ«“¡‰¡à§ß ¿“æ §◊Õ °“√À¡¥ ¿“懪πì Õ¡‘ ≈— ™π— (‡™πà °“√·¬°µ«— ¢Õß™π—È π”È ¡π— ´ßË÷ ®–‰¡°à √–®“¬µ«— ) ‚¥¬‰¡ à “¡“√∂°≈∫—   Ÿà ¿“懥¡‘ ‚¥¬µÕâ ߉¡ à ∫—  π°∫— °“√‡°¥‘ ™πÈ— §√¡’ (creaming) ´÷Ë߇ªìπ‡√◊ËÕß∑’ˇ°‘¥µ“¡ª°µ‘¢Õ߬“Õ‘¡—≈™—π∑’Ë¡’§«“¡§ß ¿“æ ‚¥¬‡ªìπ°“√·¬° ¢Õß™πÈ— πÈ”¡—π‡™àπ°π— ·µà “¡“√∂°√–®“¬µ«— ‰¥â°≈—∫‡ªπì Õ‘¡≈— ™π— ¥—߇¥¡‘ 2.3 ¬“·¢«πµ–°Õπ (Suspension) Õ“°“√„π≈”¥∫— ·√°∑∫Ë’ ßà ∫Õ°§«“¡ ‰¡à§ß ¿“æ ‰¥â·°à °“√®—∫µ—«‡ªìπ°âÕπ·¢Á߇¡Ë◊Õ‡¢¬à“¥â«¬§«“¡·√ß∑Ë’æÕ‡À¡“– °‰Á ¡Õà “®∑”„À¬â “Õ¬„àŸ π ¿“æ·¢«πµ–°Õπ‰¥Õâ °’ ·≈–‡¡ÕË◊ æ∫«“à ¢π“¥Õπ¿ÿ “§§Õà π ¢“â ß„À≠‡à °¥‘ ¢πÈ÷ ®–∫àß«“à º≈°÷ ‰¥â‡°‘¥¢÷Èπ‡ªìπ®”π«π¡“° 2.4 ∑‘߇®Õ√å·≈– “√ °—¥‡À≈« (Tinctures and fluidextracts) ∑‘߇®Õ√å  “√ °—¥‡À≈« ·≈–¬“‡µ√’¬¡Õ◊Ëπ∑Ë’§≈⓬°—π ¡—°®–¡’ ’‡¢â¡‡πË◊Õß®“°¡’ §«“¡¢πâ ¡“° ©–ππÈ— ¬“‡À≈“à π§È’ «√‰¥√â ∫— °“√µ√«® Õ∫«“à ¡°’ “√µ°µ–°ÕπÀ√Õ◊ ‰¡à 2.5 ¢Õ߇À≈«ª√“»®“°‡™È◊Õ (Sterile liquids) °“√§ß ¿“槫“¡ ª√“»®“°‡™È◊Õ¡’§«“¡ ”§—≠Õ¬à“߬‘Ëß ”À√—∫¢Õ߇À≈«ª√“»®“°‡™◊ÈÕ µ“¡ª°µ‘ °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 879

°“√ ß— ‡°µº≈µ‘ ¿—≥±å¬“‡æË◊Õ∫àß™§È’ «“¡‰¡§à ß ¿“æ °“√ªπ‡ªÕôó π®≈ÿ ™æ’ „π¢Õ߇À≈«ª√“»®“°‡™ÕÈ◊ ‰¡ à “¡“√∂µ√«®æ∫‰¥¥â «â ¬µ“‡ª≈“à ·µà§«“¡¢ÿàπ °“√‡ª≈ˬ’ π ’ °“√‡°¥‘ ø≈î å¡∑ºË’ «‘ Õπÿ¿“§À√Õ◊ «—µ∂∑ÿ Ë’‡ªπì ªÿ¬≈–‡Õ’¬¥ À√◊Õ°“√‡°¥‘ °“ä ´ ≈«â π·µà‡ªπì  ≠— ≠“≥‡µ◊Õπ«“à Õ“®¡’°“√ªπ‡ªÕôó π‡°‘¥¢È÷π·≈â« 3. √ªŸ ·∫∫¬“°Ëß÷ ·¢ßÁ (Semisolids)  ”À√—∫§√¡’ ¬“¢Èº’ ßÈ÷ ·≈–¬“‡Àπ∫Á ¢âÕ∫àߙȒ§«“¡‰¡à§ß ¿“æÕ—π¥—∫·√°°Á§◊Õ °“√‡ª≈Ë’¬π ’ À√◊Õ§«“¡‰¡à ¡Ë”‡ ¡Õ À√◊Õ °≈πË‘ ‡ª≈¬Ë’ π‰ª 3.1 §√’¡ (Creams) ·µ°µà“ß®“°¬“¢È’ºÈ÷ß §√’¡¡—°®–‡ªìπÕ‘¡—≈™—π∑Ë’¡’  à«πº ¡¢Õßπ”È ·≈–πÈ”¡—π ¢âÕ∫àß™’È¢Õߧ«“¡‰¡à§ß ¿“æ§◊Õ °“√À¡¥ ¿“æ ‡ªπì Õ¡‘ ≈— ™π— °“√‡°¥‘ º≈°÷ À√Õ◊ °“√À¥µ«— ¢Õ߇πÕ◊È §√¡’ Õπ— ‡πÕ◊Ë ß¡“®“°°“√√–‡À¬ ¢ÕßπÈ” ·≈–°“√ªπ‡ªÕôó π®ÿ≈™’æ 3.2 ¬“¢È’º÷Èß (Ointments)  —≠≠“≥∑—Ë«‰ª¢Õߧ«“¡‰¡à§ß ¿“æ„𬓠¢È’º÷Èß §◊Õ ‡°‘¥§«“¡‰¡à ¡”Ë ‡ ¡Õ¢Õ߇πÈ◊Õ¬“¢È’ºÈ÷ß ·≈–°“√·¬°µ—«¢ÕߢÕ߇À≈« ÕÕ°¡“¡“°‡°π‘ ‰ª (bleeding) √«¡∑Èß— °“√°àÕµ«— ¢Õß·°√π≈Ÿ 3.3 ¬“‡ÀπÁ∫ (Suppositories) ¢âÕ∫àß™’ÈÀ≈—°¢Õߧ«“¡‰¡à§ß ¿“æ ¢Õ߬“‡Àπ∫Á °Á§Õ◊ °“√ÕÕà 𵫗 ≈ß¡“°‡°‘π‰ª ∂ß÷ ·¡â«à“¬“‡Àπ∫Á ∫“ß™π‘¥Õ“®·Àâß ·¢ßÁ À√Õ◊ À¥µ«— ‰ª∫“â ß °“√æ∫√Õ¬‡ªÕóô ππ”È ¡π— ∫π« — ¥Àÿ Õà À¡âÿ ®–‡ªπì  ≠— ≠“≥‡µÕ◊ π ·°à‡¿ —™°√„Àâµ√«® Õ∫¬“‡ÀπÁ∫·µà≈–Õ—π¥â«¬°“√·°–‡Õ“«— ¥ÿÀÿâ¡ÕÕ°æ‘®“√≥“ À≈°— °“√∑Ë«— ‰ª (·¡®â –¡¢’ Õâ ¬°‡«âπ) §Õ◊ ¬“‡ÀπÁ∫§«√‡°Á∫√°— …“‰«â„πµŸâ‡¬πÁ Reference : Observing products for evidence of instability. USP 29, 2006 page 3030 8980 GREEN BOOK 3

À—«¢Õâ ∑¥ Õ∫„πº≈µ‘ ¿—≥±å¬“ ”‡√®Á √Ÿª Chromatographic purity À¡“¬∂ß÷ °“√∑¥ Õ∫À“ª√‘¡“≥¢Õß “√ªπ‡ªôóÕπÀ√◊Õ “√‡ Ë◊Õ¡ ≈“¬ ¥«â ¬«‘∏’‚§√¡“‚∑°√“øòï Constituted solution À¡“¬∂ß÷ À—«¢âÕ°“√∑¥ Õ∫ ”À√—∫¬“©’¥∑Ë’‡µ√’¬¡®“°ºß¬“·Àâß ”À√—∫ ≈–≈“¬‡æ◊ËÕ©¥’ çDrug for Injectioné ª√–°Õ∫¥â«¬°“√∑¥ Õ∫·≈– ß— ‡°µº≈ ¥â«¬µ“„πÀ—«¢âÕ Completeness and Clarity of Solution ·≈–‡æ◊ËÕ°“√ ∑¥ Õ∫À«— ¢Õâ Particulate matter Deliverable volume À¡“¬∂ß÷ °“√«¥— ª√¡‘ “µ√∫√√®¢ÿ Õ߬“™π¥‘ √∫— ª√–∑“π„π√ªŸ ·∫∫¢Õ߇À≈« ‡¡◊ËÕ¡’°“√∂à“¬„ ¿à “™π–ÕËπ◊ «à“¡ª’ √‘¡“µ√∂°Ÿ µÕâ ßµ√ßµ“¡∑Ë’·®ßâ ‰«â∫π©≈“° Disintegration À¡“¬∂ß÷ °“√∑¥ Õ∫‡«≈“„π°“√·µ°°√–®“¬„π ¿“«–∑°Ë’ ”Àπ¥¢Õ߬“  ”‡√®Á √ªŸ Dissolution À¡“¬∂ß÷ °“√∑¥ Õ∫°“√≈–≈“¬¢Õßµ—«¬“ ‡æË◊Õ®”·π°§ÿ≥¿“æ¢Õß º≈‘µ¿—≥±å ·≈– ‡ªìπ¢âÕ∫àߙȒ∑Ë’¥’°«à“°“√·µ°°√–®“¬ (disintegration) „π·ßà ¢Õß°“√‡ÕÕ◊È ª√–‚¬™πå¢Õ߬“ °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 8991

À—«¢âÕ∑¥ Õ∫„πº≈µ‘ ¿≥— ±å¬“ ”‡√Á®√Ÿª Dissolution (µàÕ) ‡ªπì °“√∑¥ Õ∫ in vitro ´Ëß÷ ®–· ¥ß§«“¡·µ°µà“ß√–À«à“ߺ≈‘µ¿—≥±å ¬“¢Õß·µà≈–∫√‘…—∑ πÕ°®“°π’Ȭ—ß· ¥ß§«“¡·µ°µà“ߢÕßµ”√—∫ ªí®®—¬µàÕ µ”√—∫ ·≈–æ“√“¡‘‡µÕ√åÕ◊ËπÊ„π°√–∫«π°“√º≈‘µ ´ß÷Ë °“√∑¥ Õ∫°“√≈–≈“¬¢Õß µ«— ¬“πÈ’ Õ“® —¡æ—π∏Àå √◊Õ‰¡à —¡æ—π∏å°∫— °“√∑¥ Õ∫ in vivo ( bioavailability) ∂“â in vitro dissolution  ¡— æπ— ∏°å ∫— in vivo dissolution profile  “¡“√∂ ∫àß∫Õ°∂ß’ bioavailability ‰¥â §◊Õ °“√‡ÕÕÈ◊ ª√–‚¬™πå„π√“à ß°“¬ ´ßË÷ À¡“¬∂ß÷ Õ—µ√“‡√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 ¡— æπ— ∏°å ∫— in vivo dissolution ∂◊Õ‡ªìπ physical test §Õ◊ ‡ªπì °“√µ√«® Õ∫≈°— …≥–¢Õߺ≈µ‘ ¿≥— ±å ‚¥¬»°÷ …“°“√≈–≈“¬ ¢Õßµ«— ¬“„π ¿“«–∑°Ë’ ”Àπ¥ ´÷Ë߉¡ à “¡“√∂∫ßà ∫Õ°∂ß÷ bioavailability Identification À¡“¬∂ß÷ °“√µ√«®æ ‘ ®Ÿ π‡å Õ°≈°— …≥¢å Õß “√∑µË’ Õâ ß°“√∑√“∫ «“à µ√ß°∫— ∑’Ë·®âß„π©≈“° Loss on drying À¡“¬∂ß÷ ª√¡‘ “≥ “√√–‡À¬‰¥â∑À’Ë “¬‰ª‡¡ÕË◊ ∑”„À·â Àßâ „π ¿“«–∑°’Ë ”Àπ¥ ‡™àπ 𔉪Õ∫∑ËÕ’ ≥ÿ À¿Ÿ¡‘ 100_ C ‡ªπì ‡«≈“ 3 ™«Ë— ‚¡ß Microbial limit test À¡“¬∂ß÷ °“√µ√«®°“√ªπ‡ªóôÕπ¢Õ߇™È◊Õ®ÿ≈‘π∑√’¬å „π¬“√—∫ª√–∑“π √«¡∑È—ß ¬“„™â¿“¬πÕ°∑’ˉ¡à®”‡ªìπµâÕߪ√“»®“°‡™È◊Õ (sterile) ‡™àπ syrup, suspension, aluminium hydroxide gel ‚¥¬°“√∑¥ Õ∫§«“¡ “¡“√∂„π°“√ ‡®√‘≠‡µ‘∫‚µ¢Õ߇™◊ÈÕ®ÿ≈‘π∑√’¬å∑Ë’‡°‘¥„πÕ“À“√‡≈È’¬ß‡™È◊Õ ´÷Ëß¡’µ—«Õ¬à“ß∑’˵âÕß°“√ 902 GREEN BOOK 3

À—«¢Õâ ∑¥ Õ∫„πº≈‘µ¿≥— ±¬å “ ”‡√Á®√ªŸ ∑¥ Õ∫º ¡Õ¬Ÿà ‚¥¬„™‡â ™ÕÈ◊ ¡“µ√∞“π¥ß— µÕà ‰ªπÈ’ ‰¥·â °à Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa ·≈– Salmonella typhi πÕ°®“°π’Ȭߗ ¡«’ ‘∏°’ “√∑¥ Õ∫À“®”π«π‡™ÕÈ◊ ·∫§∑’‡√’¬ ·≈–‡™ÈÕ◊ √“∑‡Ë’ °‘¥ ∫πÕ“À“√‡≈’¬È ߇™◊ÕÈ µ“¡Õ≥ÿ À¿Ÿ¡·‘ ≈–‡«≈“∑‡’Ë À¡“– ¡ ´ßË÷ ‡√’¬°«à“ °“√µ√«® Õ∫ ª√‘¡“≥®≈ÿ ‘π∑√’¬å ‡™◊ÈÕ√“ ·≈– Enterobacteria ´Ëß÷ ·ª≈º≈ ‚¥¬· ¥ß®”π«π ‡™Õ◊È Enterobacteria À√Õ◊ ‡™◊ÈÕ√“ ¬ ’ µå ∑¡Ë’ Õ’ ¬„Ÿà πµ—«Õ¬à“ß Minimum fill À¡“¬∂ß÷ ª√¡‘ “≥∑∫Ë’ √√®„ÿ π¿“™π–Õ¬“à ßπÕâ ¬µÕâ ßµ√ß°∫— ∑·’Ë ®ßâ ‰«∫â π©≈“° „™â°—∫¬“ª√–‡¿∑ cream, aerosol, spray, gel ·≈– ointment ‡ªìπµâπ Particulate matter À¡“¬∂ß÷ °“√µ√«®«—¥¢π“¥¢Õß Particles „π injection, irrigation ‡ªìπµâπ «à“¡’¢π“¥µ“¡‡°≥±å∑°’Ë ”Àπ¥À√Õ◊ ‰¡à pH À¡“¬∂ß÷ °“√«¥— §«“¡‡ªπì °√¥ - ‡∫  ¢Õß “√≈–≈“¬ Pyrogen / LAL test À¡“¬∂ß÷ °“√∑¥ Õ∫À“ “√‰æ‚√‡®π «‘∏’∑„Ë’ ™â„πªí®®∫ÿ —π¡’ 2 «∏‘ ’§◊Õ 1. °“√∑¥ Õ∫‚¥¬„™â°√–µà“¬‡ªìπ —µ«∑å ¥≈Õß ( In vivo ) „™âµ√«®À“  “√‰æ‚√‡®π‰¥∑â ÿ°™π¥‘ 2. «∏‘ ’ Bacterial Endotoxin Test ( LAL ) ‡ªìπ°“√∑¥ Õ∫„πÀ≈Õ¥ ∑¥≈Õß ( In vitro ) ´Ë÷ß„™â«‘∏’„¥«‘∏’Àπ÷Ë߇∑à“πÈ—π ·µàªí®®ÿ∫—πµ”√“¬“ ®–„™â«‘∏’ LAL ‡ªìπ  à«π„À≠à‡æ◊ËÕÀ≈°’ ‡≈¬’Ë ß°“√„™ â —µ«å∑¥≈Õß °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 913

À«— ¢Õâ ∑¥ Õ∫„πº≈µ‘ ¿—≥±å¬“ ”‡√®Á √Ÿª Related substances À¡“¬∂ß÷ °“√µ√«®À“§«“¡∫√ ‘ ∑ÿ ∏¢Ï‘ Õß “√‚¥¬µ√«®À“ “√Õπ◊Ë Ê∑‰’Ë ¡„à ™à  “√ÕÕ°ƒ∑∏‘Ï„πµ—«Õ¬à“ß ‡™àπ  “√ ≈“¬µ—«  “√ªπ‡ªôóÕπ®“°°“√ —߇§√“–Àå  “√ÕÕ°ƒ∑∏¥‘Ï ß— °≈“à « ‡ªπì µâπ Sterility test °“√µ√«® Õ∫°“√ªπ‡ªÕóô π¢Õ߇™Õ◊È ®≈ÿ π‘ ∑√¬’ „å π‡¿ ™— º≈µ‘ ¿≥— ±ªå √“»®“° ‡™È◊Õ ‡™πà ¬“©¥’ ‡ªπì µπâ Uniformity of dosage units ¡’°“√∑¥ Õ∫‰¥â 2 ·∫∫ §◊Õ - Weight variation §◊Õ §à“‡∫¬’Ë ß‡∫π®“°πÈ”Àπ—°‡©≈Ë’¬ - Uniformity of content À√◊Õ Content uniformity À¡“¬∂÷ß §«“¡ ¡Ë”‡ ¡Õ ¢Õߪ√‘¡“≥µ«— ¬“„π·µ≈à –Àπ«à ¬ „π™à«ß∑°Ë’ ”À𥉫â Water À¡“¬∂ß÷ °“√µ√«®À“§«“¡™πÈ◊ ( Moisture ) ‡æÕ◊Ë π”‰ª„™„â π°“√§”π«≥ §«“¡·√ß À√Õ◊ ª√‘¡“≥¢Õßµ«— ¬“ ”§≠— 924 GREEN BOOK 3

¥√√™π’ (Index) Àπ“â √“¬™Õ◊Ë º≈‘µ¿≥— ±¬å “ 39 60 Albendazole oral Suspension 28 Alopurinol Tablet 29 Amiodarone HCL Tablet 62 Amlodipine Tablet 13 Amitriptyline HCL Tablet 43 Ampicilin and Sulbactam for Injection 47 Azathioprine Tablet 14 Bisacodyl Tablet 15 Cefuroxime Axetil for oral Suspension 16 Cefuroxime Axetil film coated Tablet 71 Chloramphenical sodium succinate for Injection 17 Chloroquine Phosphate Tablet 63 Clarithromycin Tablet 30 Clomipramine HCL Tablet 48 Clonidine HCL Tablet 49 Dicyclomine HCL film coated Tablet 31 Dicyclomine HCL Syrup 18 Digoxin Tablet 40 Doxycycline Capsule 32 Ethambutol film coated Tablet 20 Furosemide Injection 57 Gentamycin Sulfate Injection 58 Guaifenesin Syrup Guaifenesin Tablet °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 935

¥√√™π’ (Index) Àπ“â √“¬™ËÕ◊ º≈‘µ¿—≥±å¬“ 33 34 Hydralazine HCl Tablet 21 Hydrochlorothiazide Tablet 75 Imipenem and Cilastatin for Injection 77 Insulin Injection 69 Levonorgestrel and Ethinylestradiol Tablet 50 Lidocaine HCl Injection 44 Loperamide HCL Capsule 55 Loratadine Tablet 22 Mefenamic acid Capsule 51 Meropenem for Injection 52 Metoclopramide HCl Injection 36 Metoclopramide HCl Tablet 23 Metoprolol tartrate Tablet 24 Metronidazole Tablet 64 Metronidazole Injection 25 Nortriptyline HCL Tablet 78 Ofloxacin film coated Tablet 41 Peritoneal dialysis Solution 65 Praziquantel Tablet 66 Probenecid Tablet 79 Selegiline HCL Tablet 35 Sodium chloride Injection 53 Spironolactone Tablet 26 Sulfasalazine Tablet 73 Vancomycin HCL Injection Zidovudine Capsule 946 GREEN BOOK 3

∫π— ∑°÷ (Memo) .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 97

∫π— ∑÷° (Memo) .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... .......................................................................................................................... 98 GREEN BOOK 3

°√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 99

100 GREEN BOOK 3