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우리나라는 국제의약품 규제조화위원회(ICH) 가입 및 EU 화이트리스트(GMP 서면확인서 면제 국가) 등재에 따라 2019년 11월 6일자로 의약품의 기준·규격을 정하고 있는「대한민국약전」을 제11개정에서 제12개정으로 전부 개정함으로써, 의약품의 기준·규격을 국제조화하고, 선진화하여 우수한 품질의 의약품이 유통되고, 해외 시장에서 경쟁력을 갖추도록 하였다.

이 책은 의약품 및 식품, 환경에 관련된 정량 및 기기분석에 도움이 되도록 내용을 구성하였으며 특히 제약회사 QC부서에서 이루어지는 분석관련 업무를 진행하는데 있어서 실무에 조금이나마 도움이 되도록 내용을 구성하였다.

Section 1 분석일반 / 1

제1장 분석을 위한 기초 / 3
1-1 분석데이터 평가 ············································································································· 3
1-1-1 오차 ························································································· 3
1-1-2 정확도와 정밀도 ··································································· 5
1-1-3 Q Test ················································································ 11
1-1-4 최소제곱법 (Least Square Method) ······························ 12
1-1-5 감도와 검출한계 ································································ 16
1-1-6 유효숫자 ·············································································· 20
1-2 단위환산 및 명명법 ····································································································· 24
1-2-1 단위계 ················································································· 24
1-2-2 단위환산 ·············································································· 26
1-2-3 무기화합물의 명명법 ························································· 27
1-3 화학분석 ························································································································ 28
1-3-1 개요 ······················································································· 28
1-3-2 화학분석의 분류 ································································ 29
1-3-3 화학분석의 일반적 단계 ··················································· 32
1-3-4 부피분석 ·············································································· 44

제2장 대한민국약전 실험의 기초 / 57
2-1 기초준비 ························································································································ 57
2-1-1 기구와 시약 ········································································ 57
2-1-2 무게(질량)의 측정 ····························································· 65
2-1-3 부피의 측정 ·········································································· 69
2-2 기초의약분석실험 ········································································································· 79
2-2-1 서론 ······················································································· 79
2-2-2 실험에서의 일반적인 주의사항 ·········································· 80
2-2-3 실험노트 기록방법 ····························································· 84
2-2-4 실험보고서 종류 ································································ 85
2-2-5 실험보고서 작성 요령 ························································· 85
2-3 대한민국약전 ·············································································································· 101
2-3-1 약전의 의미 ········································································ 101
2-3-2 의약품의 규격 ···································································· 102
2-3-3 약전의 역사 ···································································· 105
2-3-4 대한민국약전 통칙 ···························································· 107
2-3-5 대한민국약전 일반시험법 (일부발췌) ··························· 135

Section2 의약품 기기분석/177

제1장 전자기 복사선과 광학 / 179
1-1 개론 ····························································································································· 179
1-2 전자기 복사선의 파동성 ··························································································· 181
1-3 전자기 복사선의 입자성 ··························································································· 183
1-4 Beer의 법칙 ··············································································································· 188

제2장 자외-가시부 흡광광도법 / 191
2-1 개론 ····························································································································· 191
2-2 정성분석 ····················································································································· 192
2-2-1 용매 ················································································· 194
2-2-2 흡수스펙트럼 작성 ························································· 195
2-3 정량분석 ····················································································································· 196
2-3-1 Beer 법칙 ········································································· 197
2-3-2 Beer 법칙의 문제점 ························································ 200
2-3-3 정확도와 정밀도 ······························································ 202
2-3-4 정량 과정에서 야기되는 오차 ········································ 205
2-3-5 분광 측정 오차 ································································ 207
2-3-6 일반적 정량과정 ······························································ 209
2-3-7 혼합물의 정량 ·································································· 21
2-4 측정 장치 및 기기 ····································································································· 214
2-4-1 광원 ··················································································· 216
2-4-2 파장선택부 ········································································ 217
2-4-3 시료부 (흡수용기, cell) ·············································· 221
2-4-4 검출기 (detector) ··························································· 222
2-4-5 광학계 ················································································· 223
2-5 정량분석에의 응용 ····································································································· 224
2-5-1 정량법의 종류 ····················································································· 224
2-6 대한약전 의약품각조에의 응용 ················································································ 232
2-6-1 확인시험 ············································································· 232
2-6-2 시성치로서의 ································································ 234
2-6-3 순도시험 ·········································································· 234
2-6-4 정량법 ··············································································· 235

제3장 크로마토그래피 / 241
3-1개론 ······························································································································· 241
3-2 크로마토그래피법의 기초이론 ·················································································· 245
3-2-1 이론단수(N) 및 유효이론단수(Neff) ····························· 246
3-2-2 이론단 칼럼높이 (Height Equivalent to a Theoretical Plate) 247
3-2-3 칼럼의 용량인자(capacity factor 혹은 retention factor: k') 252
3-2-4 분리계수/분리인자 (separation factor : α) ··················· 253
3-2-5 분리도 (Resolution Function: RS) ······························· 253
3-2-6 분리능의 최적비 ······························································ 256
3-3 가스크로마토그래피 (GC) ························································································ 256
3-3-1 장치 ······································································································ 256
3-4 고성능액체크로마토그래피(HPLC) ·········································································· 270
3-4-1 HPLC의 특징 ····································································· 271
3-4-2 장치의 개요 ········································································ 271
3-4-3 크로마토그래피 분리 메커니즘 ········································ 317
3-4-5 이동상 용매의 선택 ··························································· 357
3-4-6 이동상의 제조 ·································································· 365
3-4-7 시료의 분석 ········································································ 373

Section 3 기타 물리분석 및 측광분석 / 397

제1장 pH 측정법 / 399
1-1 전기화학(Electrochemistry)개론 ··········································································· 399
1-1-1 산화/환원반응 (Redox Reaction) ·································· 400
1-1-2 산화환원전위 (Oxidation Reduction potential ; ORP) 401
1-1-3 전기화학 셀과 표준수소전극(standard hydrogen electrode) 405
1-1-4 표준전극전위 (Standard electrode potential) ············ 408
1-1-5 전극전위 표현법 ······························································ 412
1-2 Nernst 식 ··················································································································· 413
1-3 pH와 수소이온농도 [H+] ······················································································ 417
1-3-1 물의 해리(전리)와 pH ······················································ 418
1-3-2 pH electrode (pH 전극) ·················································· 421
1-3-3 pH meter의 보정(Calibration) 및 측정 응용 ·············· 424
1-3-4 간단한 용액의 pH 계산 ·················································· 430

제2장 선광도 (Optical Rotation) 측정 / 435
2-1 빛의 평면편광 ········································································································ 436
2-1-1 편광자(polarizer)와 검광자(Analyzer) ························· 437
2-1-2 선광도(Optical rotation)와 선광계(Polarimeter) ······· 438
2-2 이성질체(Isomer) ·································································································· 439
2-2-1 구조이성질체 (2차원, 평면적) ···································· 440
2-2-2 입체이성질체 (3차원, 입체적) ······································ 442
2-3 선광도 및 비선광도의 측정 ······················································································ 448
2-3-1 편광계 장치의 구성과 측정원리 ···································· 448
2-3-2 선광도의 측정 ·································································· 450
2-3-3 ORD, CD 분광광도계 ···················································· 454

제3장 적외부 분광광도법 / 457
3-1 분자의 적외선 흡수 ··································································································· 459
3-2 분자의 진동 ················································································································ 461
3-3 분자진동의 파수 (ν) ································································································· 464
3-4 적외선 흡수스펙트럼의 분석에의 응용 ··································································· 468
3-4-1 정성분석 및 화합물 구조 추정 ······································ 468
3-4-2 적외선 스펙트럼 해석의 기초 ········································ 472
3-4-3 정량분석 ·········································································· 475
3-5 적외선 분광광도계 장치 ··························································································· 477
3-5-1 분산형 적외선 분광광도계 ··········································· 478
3-5-2 간섭형 적외선 분광광도계(FTIR) ······························· 483
3-5-3 비분산 적외선분석기(NDIR) ········································ 485
3-5-4 시료의 취급 및 측정 ····················································· 48