Rosuvastatin impurity 245
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포함 사항: HPLC, MASS/LC-MS, 1H NMR, FT-IR, 함량, 구조 규명 보고서(SER), 그리고 제품에 따라 추가 분석 데이터가 제공됩니다.

147118-41-0Rosuvastatin impurity 245

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카탈로그 번호:VE0026592
CAS 번호:147118-41-0
분자식:C15H16FN3O
분자량:273.31 g/mol

에 대한 추가 정보 CAS 147118-41-0

모약물

Rosuvastatin

IUPAC명

4-(4-fluorophenyl)-2-(methylamino)-6-propan-2-ylpyrimidine-5-carbaldehyde

SMILES

CNC1=NC(C2=CC=C(F)C=C2)=C(C([H])=O)C(C(C)C)=N1

InChI

InChI=1S/C15H16FN3O/c1-9(2)13-12(8-20)14(19-15(17-3)18-13)10-4-6-11(16)7-5-10/h4-9H,1-3H3,(H,17,18,19)

설명

Rosuvastatin impurity 245 (CAS 147118-41-0) is a characterized process-related and degradation impurity encountered during synthesis and stability testing of rosuvastatin substances; it is structurally distinct and typically monitored as part of impurity profiling. Accurate identification and quantification are achieved using orthogonal analytical techniques such as HPLC-UV, LC-MS/MS and NMR to confirm retention time, mass fragmentation and structural attributes. Control strategies align with ICH Q3A/Q3B guidance and include validated limits, forced-degradation studies and stability-indicating methods to ensure consistent removal or control. Batch-to-batch variability, formation pathways and impurity acceptance criteria are critical for quality and regulatory submissions.

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