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

GMP KnowledgeIch Q7hard

Question

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
MiniMax M2.7	100.0%	11.4s	146	628
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
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
Gemma 4 31B IT	100.0%	7.6s	116	250
GPT-5.4	100.0%	3.1s	112	205
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
DeepSeek V4 Flash	100.0%	13.5s	107	496
Gemma 4 26B A4B IT	100.0%	7.2s	116	248
Qwen3.5-397B-A17B	0.0%	44.1s	120	1,288
Qwen3.5-35B-A3B	0.0%	6.7s	120	1,043