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

Knowledge QAIch 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
Gemini 3.1 Flash-Lite	100.0%	1.8s	104	214
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
Gemini 3 Flash	100.0%	1.9s	103	220
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
Qwen3.5-397B-A17B	0.0%	44.1s	120	1,288
Qwen3.5-35B-A3B	0.0%	6.7s	120	1,043