ichq7-003

GMP KnowledgeIch Q7hard

Question

According to ICH Q7, which of the following best describes the requirements for impurity profiles of APIs?

Choices

A. Impurity profiles are only needed for APIs used in clinical trials
B. The impurity profile should be compared at appropriate intervals against the impurity profile in the regulatory submission, and it should describe identified and unidentified impurities
C. Only genotoxic impurities require profiling; other impurities need only meet overall purity limits
D. Impurity profiles need only be established once during initial development and do not require ongoing monitoring

Cross-Model Comparison

Model	Score	Latency	Tokens In	Tokens Out
GLM-5.3	N/A	N/A	-	-
Qwen3.8-Flash	N/A	N/A	-	-
Qwen3.8 Max (2.4T-A95B)	N/A	N/A	-	-
Hy4 Preview	N/A	N/A	-	-
Muse Glimmer 30B	N/A	N/A	-	-
MiniMax M3	N/A	N/A	-	-
Llama 4 Scout	100.0%	1.1s	114	410
Llama 4 Maverick	100.0%	3.4s	183	394
Llama 3.3 70B Instruct	100.0%	10.3s	120	195
Mistral Small 2603	100.0%	2.0s	119	308
DeepSeek-V3.2	100.0%	4.8s	113	126
DeepSeek-R1	100.0%	22.4s	113	852
DeepSeek-R1-Distill-Qwen-32B	100.0%	26.4s	112	595
Mistral Large 3 675B	100.0%	6.2s	107	355
Gemini 3.1 Pro	100.0%	13.7s	103	848
Gemini 3 Flash	100.0%	1.9s	103	220
Gemini 3.1 Flash-Lite	100.0%	1.8s	104	214
Qwen3.6 27B	100.0%	44.2s	120	1,590
Qwen3.6 35B A3B	100.0%	5.4s	120	998
DeepSeek V4 Pro	100.0%	12.0s	107	446
DeepSeek-V3.2	100.0%	6.5s	113	103
Llama 4 Scout	100.0%	13.6s	172	372
DeepSeek V4 Flash	100.0%	13.5s	107	496
Gemma 4 26B A4B IT	100.0%	7.2s	116	248
Gemma 4 31B IT	100.0%	7.6s	116	250
MiniMax M2.7	100.0%	11.4s	146	628
Claude Opus 4.8	100.0%	7.9s	179	556
GLM-5.2	100.0%	6.8s	121	793
Llama 4 Maverick	100.0%	6.4s	172	303
Llama 3.3 70B Instruct	100.0%	10.8s	180	343
Mistral Small 2603	100.0%	2.3s	182	288
Mistral Large 3 675B	100.0%	3.5s	170	215
Qwen3.5-35B-A3B	100.0%	12.2s	182	1,202
Qwen3.6 27B	100.0%	30.9s	182	1,062
Qwen3.6 35B A3B	100.0%	49.2s	182	1,410
Qwen3.5-397B-A17B	100.0%	13.5s	182	1,174
DeepSeek V4 Pro	100.0%	7.4s	167	420
DeepSeek-V3.2	100.0%	6.7s	173	149
DeepSeek V4 Flash	100.0%	3.0s	167	117
DeepSeek-R1	100.0%	75.6s	166	862
Gemma 4 26B A4B IT	100.0%	4.3s	178	274
Gemma 4 26B A4B IT	100.0%	5.8s	178	271
Gemma 4 31B IT	100.0%	4.6s	178	199
Hy4 Preview	100.0%	22.9s	184	1,726
MiniMax M2.7	100.0%	8.6s	204	589
GLM-5.2	100.0%	12.0s	181	567
Qwen3.8 27B	100.0%	3.8s	292	439
Kimi K3	100.0%	23.9s	252	839
GLM-5.3-Flash	100.0%	15.7s	181	561
Muse Glimmer 30B	100.0%	5.3s	218	316
GPT-5.6 Luna	100.0%	2.1s	170	78
GPT-5.4 mini	100.0%	772ms	112	66
GPT-5.4 nano	100.0%	641ms	112	44
Claude Haiku 4.5	100.0%	4.0s	128	358
Claude Sonnet 4.6	100.0%	7.9s	128	316
Claude Opus 4.6	100.0%	11.6s	128	420
GPT-5.6 Terra	100.0%	1.8s	170	64
GPT-5.4	100.0%	3.1s	112	205
Qwen3.8 Max (2.4T-A95B)	100.0%	2.1s	224	160
Qwen3.8-Flash	100.0%	2.3s	233	187
MiniMax M3	100.0%	7.0s	339	420
GLM-5.3	100.0%	74.5s	181	13,837
Claude Opus 5	100.0%	7.2s	267	390
Claude Sonnet 5	100.0%	2.3s	267	9
Claude Haiku 4.5	100.0%	3.0s	192	304
GPT-5.6 Sol	100.0%	1.8s	170	40
Qwen3.5-35B-A3B	0.0%	6.7s	120	1,043
Qwen3.5-397B-A17B	0.0%	44.1s	120	1,288

ichq7-003

Cross-Model Comparison

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