No

Bab dan Sub-Bab

Skala
Prioritas

Tinjauan Umum Senyawa Aktif dan Sediaannya

1.1

Deskripsi umum senyawa aktif

Judul Buku

Farmakope Indonesia (FI)

United States Pharmacopeia (USP)
British Pharmacopeia (BP)
European Pharmacopeia (EP)
Japanese Pharmacopeia (JP)
The Pharmaceutical Codex (TPC)

Florey: Analytical Profiles of Drug Substances and Excipients

Nama sinonim

AHFS Drug Information

Martindale: The Complete Drug Reference

Florey: Analytical Profiles of Drug Substances and Excipients
The Pharmaceutical Codex (TPC)

Farmakope Indonesia (FI)

Struktur molekul

Farmakope (umum, yang digunakan sebelumnya)

Clarke's Analysis of Drugs and Poisons

Rumus molekul, bobot molekul

Farmakope (umum, yang digunakan sebelumnya)

Clarke's Analysis of Drugs and Poisons

Florey: Analytical Profiles of Drug Substances and Excipients
Kandungan (tidak kurang %)

Farmakope (umum, yang digunakan sebelumnya)

Clarke's Analysis of Drugs and Poisons

Pemerian

Farmakope (umum, yang digunakan sebelumnya)

Clarke's Analysis of Drugs and Poisons

Data kelarutan

Farmakope (umum, yang digunakan sebelumnya)

The Pharmaceutical Codex (TPC)

Clarke's Analysis of Drugs and Poisons

Florey: Analytical Profiles of Drug Substances and Excipients
pH

Farmakope (umum, yang digunakan sebelumnya)

The Pharmaceutical Codex (TPC)

pKa

Clarke's Analysis of Drugs and Poisons

Florey: Analytical Profiles of Drug Substances and Excipients
Florey: Analytical Profiles of Drug Substances and Excipients
Merck Index
Clarke's Analysis of Drugs and Poisons

Koefisien partisi

The Pharmaceutical Codex (TPC)

Clarke's Analysis of Drugs and Poisons

Wadah dan penyimpanan

Farmakope (umum, yang digunakan sebelumnya)

Data stabilitas

Merck Index
Florey: Analytical Profiles of Drug Substances and Excipients
The Pharmaceutical Codex (TPC)

Merck Index
Inkompatibilitas

The Pharmaceutical Codex (TPC)

Martindale: The Complete Drug Reference

Data fisika: titik lebur, koefisien partisi,

rotasi optik

Clarke's Analysis of Drugs and Poisons

Florey: Analytical Profiles of Drug Substances and Excipients

1.2

Definisi umum bentuk sediaan terkait

Farmakope (umum, yang digunakan sebelumnya)

Definisi sediaan terkait zat aktif

Farmakope (umum, yang digunakan sebelumnya)

1.3

Dasar pertimbangan dan landasan hukum

penggolongan obat

SK Menkes/UU

1.4

Penandaan pada wadah, leaflet , atau

brosur obat

SK Menkes/UU

1.5

Nomor registrasi dan nomor bets

UU

Uraian dan Analisis Farmakologi

2.1

Nama obat dan sinonim

MIMS Petunjuk Konsultasi

AHFS Drug Information

Farmakope Indonesia (FI)

The Pharmaceutical Codex (TPC)
USP Drug Information (USPDI)

Goodman and Gilman's The Pharmacological Basis of Thera

Martindale: The Complete Drug Reference
Katzung's Basic And Clinical Pharmacology
Golongan terapi obat (farmakologi dan
kimia)

AHFS Drug Information

Katzung's Basic And Clinical Pharmacology

Goodman and Gilman's The Pharmacological Basis of Thera
Martindale: The Complete Drug Reference
Florey: Analytical Profiles of Drug Substances and Excipients
2.2

Bentuk senyawa aktif

AHFS Drug Information

Katzung's Basic And Clinical Pharmacology

Goodman and Gilman's The Pharmacological Basis of Thera
2.3

Efek farmakologi

AHFS Drug Information

Goodman and Gilman's The Pharmacological Basis of Thera

Drug Facts and Comparisons

Martindale: The Complete Drug Reference

2.4

Mekanisme kerja obat dalam tubuh

AHFS Drug Information

USP Drug Information (USPDI)

Goodman and Gilman's The Pharmacological Basis of Thera

Martindale: The Complete Drug Reference
Drug Facts and Comparisons

Katzung's Basic And Clinical Pharmacology

Handbook of Nonprescription Drug
2.5

Nasib obat dalam tubuh

AHFS Drug Information

Goodman and Gilman's The Pharmacological Basis of Thera

Martindale: The Complete Drug Reference
Clarke's Analysis of Drugs and Poisons

2.6

Absorpsi

AHFS Drug Information

Distribusi

USP Drug Information (USPDI)

Metabolisme

USP Drug Information (USPDI)

Eliminasi

USP Drug Information (USPDI)

Indikasi dan dasar pemilihan

AHFS Drug Information

Goodman and Gilman's The Pharmacological Basis of Thera

Martindale: The Complete Drug Reference
USP Drug Information (USPDI)
Drug Facts and Comparisons
2.7

Kontraindikasi dan alasannya

AHFS Drug Information

Drug Facts and Comparisons

2.8

Dasar dan perhitungan dosis

AHFS Drug Information

Drug Facts and Comparisons
USP Drug Information (USPDI)

2.9

Aturan Pakai

AHFS Drug Information

Drug Facts and Comparisons
USP Drug Information (USPDI)

2.10

Efek samping

Goodman and Gilman's The Pharmacological Basis of Thera

AHFS Drug Information
Drug Facts and Comparisons
USP Drug Information (USPDI)

2.11

Toksisitas

Katzung's Basic And Clinical Pharmacology

Goodman and Gilman's The Pharmacological Basis of Thera
AHFS Drug Information
Drug Facts and Comparisons
USP Drug Information (USPDI)

2.12

Interaksi obat

Merck Index
Martindale: The Complete Drug Reference
Katzung's Basic And Clinical Pharmacology
Stockley's Drug Interaction

2.13

Penggunaan pada kondisi khusus pasien

Goodman and Gilman's The Pharmacological Basis of Thera

AHFS Drug Information
Drug Facts and Comparisons
USP Drug Information (USPDI)

2.14

Peringatan dan perhatian

Goodman and Gilman's The Pharmacological Basis of Thera

AHFS Drug Information

British National Formulary (BNF)

Drug Facts and Comparisons
USP Drug Information (USPDI)
2.15

Cara penyimpanan

AHFS Drug Information

USP Drug Information (USPDI)
Drug Facts and Comparisons

2.16

Contoh sediaan yang beredar di pasaran

serta kekuatannya

MIMS Petunjuk Konsultasi

AHFS Drug Information
USP Drug Information (USPDI)

Katzung's Basic And Clinical Pharmacology

2.17

Analisis farmakologi Katzung

Analisis Praformulasi, Formulasi, dan Usulan Formula

3.1

Pendekatan Formula
Pemerian

Farmakope (umum, yang digunakan sebelumnya)

Kelarutan

Farmakope (umum, yang digunakan sebelumnya)

The Pharmaceutical Codex (TPC)

Clarke's Analysis of Drugs and Poisons

Florey: Analytical Profiles of Drug Substances and Excipients
pH

Farmakope (umum, yang digunakan sebelumnya)

The Pharmaceutical Codex (TPC)

Florey: Analytical Profiles of Drug Substances and Excipients

Clarke's Analysis of Drugs and Poisons

pKa

Stabilitas

Florey: Analytical Profiles of Drug Substances and Excipients

Merck Index
Clarke's Analysis of Drugs and Poisons
Florey: Analytical Profiles of Drug Substances and Excipients
The Pharmaceutical Codex (TPC)

Merck Index
Inkompatibilitas

Titik leleh

Koefisien partisi

Rotasi jenis/rotasi optik

3.1.1

Formula Umum

3.1.2

Formula Pustaka

The Pharmaceutical Codex (TPC)

Martindale: The Complete Drug Reference

Florey: Analytical Profiles of Drug Substances and Excipients
Clarke's Analysis of Drugs and Poisons
Florey: Analytical Profiles of Drug Substances and Excipients
Clarke's Analysis of Drugs and Poisons
Florey: Analytical Profiles of Drug Substances and Excipients
Clarke's Analysis of Drugs and Poisons
Handbook of Pharmaceutical
Handbook of Pharmaceutical
Handbook of Pharmaceutical
Handbook of Pharmaceutical
Handbook of Pharmaceutical
Handbook of Pharmaceutical
Generic Drug Formulation

Manufacturing:
Manufacturing:
Manufacturing:
Manufacturing:
Manufacturing:
Manufacturing:

The Pharmaceutical Codex (TPC)

AHFS Drug Information
Formularium Nasional
3.1.3

Pengembangan Formula

3.2
Usulan formula utama dan alternatif
3.3

Monografi Eksipien

Pembuatan dan Evaluasi Farmasetika Sediaan Akhir

4.1

Metode pembuatan sediaan

4.2

Perhitungan dan penimbangan

4.3

Prosedur pembuatan sediaan

4.4

In-process control (IPC)

Handbook of Pharmaceutical Excipients

Farmakope Indonesia (FI)

Organoleptik
4.5
Uji mutu farmaseutika sediaan akhir
4.5.1

Evaluasi fisika

Farmakope Indonesia (FI)

United States Pharmacopeia (USP)
British Pharmacopeia (BP)

Homogenitas
Volume sedimentasi
Kemampuan redispersi
Penetapan bobot jenis
Penetapan pH
Uji volume terpindahkan

Farmakope Indonesia (FI), halaman 1030

Farmakope Indonesia (FI), halaman 1029
Farmakope Indonesia (FI), halaman 1089

Viskositas
Isi minimum

Farmakope Indonesia (FI), halaman 997

Compressed S
Uncompressed
Liquid
Semisolid
OTC
Sterile

Stabilitas gel
Kebocoran tube

Farmakope Indonesia (FI), halaman 1086

Uji difusi
Uji disolusi
Uji efektivitas pengawet antimikroba
4.5.2

Farmakope Indonesia (FI), halaman 854

Evaluasi kimia

Bab 5

Evaluasi biologi

Farmakope Indonesia (FI)

Farmakope Indonesia (FI), halaman 855

Uji sterilitas
Penetapan potensi antibiotika secara
mikrobiologi

Farmakope Indonesia (FI), halaman 891

Uji efektivitas pengawet

Farmakope Indonesia (FI)

5 Analisis Kimia dan Pengujian Mutu Bahan Baku Sediaan

Gugus fungsi, jenis ikatan, rangka

molekul, dan ion yang dapat digunakan
sebagai dasar dan ion yang dapat
5.1 digunakan sebagai dasar untuk analisis

Golongan obat secara kimia

Goodman and Gilman's The Pharmacological Basis of Thera

Florey: Analytical Profiles of Drug Substances and Excipients

Gugus fungsi

Fessenden's Organic Chemistry

Jenis ikatan

Fessenden's Organic Chemistry

Rumus molekul inti senyawa

Data fisika dan kimia

Sifat zat

Farmakope Indonesia (FI)

Florey: Analytical Profiles of Drug Substances and Excipients
Clarke's Analysis of Drugs and Poisons

Metode reaksi gugus fungsi

Reaksi anion kation
5.2 Data Spektrofotometri

5.3 Data dan sistem kromatografi

Farmakope Indonesia (FI)

Florey: Analytical Profiles of Drug Substances and Excipients
Instrumental Data Analysis 1-6
UV and IR Spectra Pharmaceutical Substances (UV and IR)
Clarke's Analysis of Drugs and Poisons
Florey: Analytical Profiles of Drug Substances and Excipients
Instrumental Data Analysis 1-6
Clarke's Analysis of Drugs and Poisons

Kromatografi kertas
KLT

KCKT (HPLC)
Kormatografi gas (GC)

Farmakope Indonesia (FI)

British Pharmacopeia (BP)
Florey: Analytical Profiles of Drug Substances and Excipients
Florey: Analytical Profiles of Drug Substances and Excipients
Florey: Analytical Profiles of Drug Substances and Excipients
Clarke's Analysis of Drugs and Poisons

5.4 Stabilita dan kemurnian

5.4.1

Stabilita Analisis berdasarkan struktur

Farmakope Indonesia (FI)

The Pharmaceutical Codex (TPC)

5.4.2

Kemurnian
Rotasi optik

Kadar air
Uji batas sulfat

British Pharmacopeia (BP)

Farmakope Indonesia (FI)
Farmakope Indonesia (FI)
British Pharmacopeia (BP)

Jarak lebur
Susut pengeringan

Farmakope Indonesia (FI), halaman 1032

Farmakope Indonesia (FI), halaman 1043

Sisa pemijaran
Batas logam berat
Uji batas arsen

Farmakope Indonesia (FI), halaman 932

Farmakope Indonesia (FI), halaman 926

Metode analisis yang diusulkan dalam

5.5 pengujian bahan baku dan sediaan
5.5.1

Identifikasi bahan baku (spektro, KLT)

Farmakope Indonesia (FI)

United States Pharmacopeia (USP)

Florey: Analytical Profiles of Drug Substances and Excipients
5.5.2

Penentuan kadar bahan baku

Farmakope (umum, yang digunakan sebelumnya)

The Pharmaceutical Codex (TPC)

5.5.3

Identifikasi bahan baku dalam sediaan

5.5.4

Penetapan kadar bahan baku dalam

sediaan

Masalah analisis yang disebabkan kadar

5.6 dalam matriks dalam sampel
5.6.1

Pengaruh matriks dalam sampel sediaan

Pengaruh eksipien dalam sampel sediaan

5.7 Preparasi sampel

Usulan pengujian mutu bahan baku dan
5.8 sediaan
5.8.1

Metode identifikasi bahan baku

5.8.2

Metode penetapan kadar bahan baku

5.8.3

Uji kemurnian bahan baku

5.8.4

Metode identifikasi bahan baku dalam

sediaan

5.8.5

Metode penetapan

Farmakope (umum, yang digunakan sebelumnya)

Edisi

4
32

Tahun

Bentuk

1995 Ebook & Kavling A5

2009 Ebook
2009 Ebook

2005 Ebook

16

2011 Ebook

12

1994 Kavling A5/6

34

2009 Ebook
2010 Kavling A5/6

36

2009 Ebook & Kavling A5

34

2009 Ebook

12

1994 Kavling A5/6

1995 Ebook & Kavling A5

2004 Ebook & Kavling A6

Kavling A5/6

Kavling A5/6
4
34

2004 Ebook & Kavling A6

2009 Ebook
Kavling A5/6

2004 Ebook & Kavling A6

Kavling A5/6

2004 Ebook & Kavling A6

Kavling A5/6

12
4
34

1994 Kavling A5/6

2004 Ebook & Kavling A6
2009 Ebook
Kavling A5/6

12
4

1994 Kavling A5/6

2004 Ebook & Kavling A6

34

2009 Ebook

34

2009 Ebook
2009 Ebook & Kavling A5

4
12
4

2004 Ebook & Kavling A6

1994 Kavling A5/6
2004 Ebook & Kavling A6
Kavling A5/6
2009 Ebook & Kavling A5

34

2009 Ebook

12

1994 Kavling A5/6

2009 Ebook & Kavling A5

12

1994 Kavling A5/6

36

2009 Ebook

4
34

2004 Ebook & Kavling A6

2009 Ebook

Kavling A5/6
Kavling A5/6

2011 Kavling A5/6

2010 Kavling A5/6

4

1995 Ebook & Kavling A5

12

1994 Kavling A5/6

27

2007 Kavling A5/6

12

2011 Ebook & Kavling A5

36

2009 Ebook & Kavling A5

12

2012 Ebook & Kavling A5

2010 Kavling A5/6

12

2012 Ebook & Kavling A5

12

2011 Ebook & Kavling A5

36

2009 Ebook & Kavling A5

34

2009 Ebook
2010 Kavling A5/6

12

2012 Ebook & Kavling A5

12

2011 Ebook & Kavling A5

2010 Kavling A5/6

12

2011 Ebook
2007 Kavling A5/6

36

2009 Ebook & Kavling A5

2010 Kavling A5/6

27

2007 Kavling A5/6

12

2011 Ebook & Kavling A5

36

2009 Ebook & Kavling A5

2007 Kavling A5/6

12

2012 Ebook & Kavling A5

16

2009 Ebook
2010 Kavling A5/6

12

2011 Ebook & Kavling A5

36

2009 Ebook & Kavling A5

2004 Ebook & Kavling A6

2010 Kavling A5/6

27

2007 Kavling A5/6

27

2007 Kavling A5/6

27

2007 Kavling A5/6

2010 Kavling A5/6

12

2011 Ebook & Kavling A5

36

2009 Ebook & Kavling A5

27

2007 Kavling A5/6

2007 Kavling A5/6
2010 Kavling A5/6

2007 Kavling A5/6

2010 Kavling A5/6
2007 Kavling A5/6
27

2007 Kavling A5/6

2010 Kavling A5/6
2007 Kavling A5/6

27

2007 Kavling A5/6

12

2011 Ebook & Kavling A5

2010 Kavling A5/6
2007 Kavling A5/6

27

2007 Kavling A5/6

12

2012 Ebook & Kavling A5

12

2011 Ebook & Kavling A5

2010 Kavling A5/6
2007 Kavling A5/6

27

2007 Kavling A5/6

2009 Ebook & Kavling A5

36

2009 Ebook & Kavling A5

12

2012 Ebook & Kavling A5

9
12

2010 Ebook
2011 Ebook & Kavling A5
2010 Kavling A5/6
2007 Kavling A5/6

27

2007 Kavling A5/6

12

2011 Ebook & Kavling A5

2010 Kavling A5/6

61

2011 Ebook
2007 Kavling A5/6

27

2007 Kavling A5/6

2010 Kavling A5/6

27

2007 Kavling A5/6

2007 Kavling A5/6
2011 Kavling A5/6
2010 Kavling A5/6

27

2007 Kavling A5/6

12

2012 Ebook & Kavling A5

1995 Ebook

1995 Ebook

12
4

1994 Kavling A5/6

2004 Ebook & Kavling A6

34

2009 Ebook

12

1994 Kavling A5/6

34

2009 Ebook

2004 Ebook & Kavling A6

34

2009 Ebook
2009 Ebook & Kavling A5

2004 Ebook & Kavling A6

34

2009 Ebook

12

1994 Kavling A5/6

2009 Ebook & Kavling A5

12

1994 Kavling A5/6

36

2009 Ebook & Kavling A5

34

2009 Ebook

4
34
4
34

2004 Ebook & Kavling A6

2009 Ebook
2004 Ebook & Kavling A6
2009 Ebook

2004 Ebook & Kavling A6

2009 Ebook

2009 Ebook

2009 Ebook

2009 Ebook

2009 Ebook

2009 Ebook

1998 Ebook & Kavling A5

12

1994 Kavling A5/6

2010 Kavling A5/6

1978 Kavling A3/4

2009 Ebook

1995 Ebook & Kavling A5

1995 Ebook & Kavling A5

32

2009 Ebook & Kavling A5

2009 Ebook

1995 Ebook & Kavling A5

1995 Ebook & Kavling A5

1995 Ebook & Kavling A5

1995 Ebook & Kavling A5

1995 Ebook & Kavling A5

1995 Ebook & Kavling A5

1995 Ebook & Kavling A5

1995 Ebook & Kavling A5

1995 Ebook & Kavling A5

1995 Ebook & Kavling A5

12

2011 Ebook & Kavling A5

34

2009 Ebook

1995 Kavling A3/4

1995 Kavling A3/4

34

2009 Ebook & Kavling A5

2004 Ebook

1995 Ebook & Kavling A6

1995 Ebook & Kavling A5

2004 Ebook

2006 Ebook

nd IR)

2002 Ebook
4

1995 Ebook & Kavling A6

2004 Ebook

2006 Ebook

1995 Ebook & Kavling A6

1995 Ebook & Kavling A5

2009 Ebook

2004 Ebook

2004 Ebook

2004 Ebook

1995 Ebook & Kavling A6

1995 Ebook & Kavling A5

12

1994 Kavling A5/6

2009 Ebook
4

1995 Ebook & Kavling A5

1995 Ebook & Kavling A5

2009 Ebook

1995 Ebook & Kavling A5

1995 Ebook & Kavling A5

1995 Ebook & Kavling A5

1995 Ebook & Kavling A5

1995 Ebook & Kavling A5

32

2009 Ebook & Kavling A5

12

2004 Ebook

1994 Kavling A5/6

Kavling A5/6