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Impurity reference standards

Impurity Reference Standards
Impurity reference standards are physical benchmarks for implementing pharmaceutical quality standards. They serve as critical carriers for metrological traceability, acting as specialized tools to assess drug quality, establish measurement baselines, determine drug authenticity and efficacy, and calibrate testing instruments and methodologies. Within national drug standards, they are state-issued reference materials for both quantitative and qualitative analysis of pharmaceuticals.

Primary Functions

1.Quality Control Applications:

Used as standard substances for drug identification, purity testing, and content determination.
Function as specialized "measuring tools" that directly impact the accuracy and reproducibility of test results.

2.Targeted Impurity Control:

Essential for increasingly stringent impurity profiling, including localization, quantification, and response factor determination of specific impurities mandated by modern pharmacopeial standards.

Selection Criteria

1.Source Availability:

Common Process-Related Impurities (e.g., by-products) are typically obtainable from pharmacopeial authorities (USP, EP) or certified suppliers (e.g., LGC).
Unique or Rare Impurities often require in-house synthesis, extraction, or isolation. Such impurities lack commercially available reference standards and necessitate method development, validation, and calibration to enable accurate quantification in active pharmaceutical ingredients (APIs).

2.Critical Parameters for Procurement:

Purity: The cornerstone of reference standard quality (e.g., ≥98% by HPLC).
Shelf Life: Indicates stability under specified storage conditions.
Documentation: Complete Certificate of Analysis (COA) and spectral data (e.g., NMR, LC-MS).
Supplier Credentials: ISO/IEC 17034 accreditation, GMP compliance, and traceability to international standards.

Hengyuan Fine Chemical’s PCL Impurity Reference Standards
Hengyuan Fine Chemical supplies PCL-branded impurity reference standards with the following advantages:

Full Documentation: Batch-specific COA and spectral data provided.
Direct Manufacturing Supply: Eliminates intermediaries, ensuring cost-effectiveness and rapid delivery.
Comprehensive Portfolio: Covers a wide range of pharmacopeial and custom-synthesized impurities.
Regulatory Readiness: Supports compliance with ICH, USP, and ChP requirements.

Product Number	Product Name	CAS No.	Molecular Formula
Product Number:PCL-#-Me761-25mg	Product Name:4'-Methylacetophenone; p-Methylacetophenone	CAS No.:122-00-9	Molecular Formula:
Product Number:PCL-#-Ai100-50mg	Product Name:Acetaminophen impurity M (4,4'-iminodiol)	CAS No.:1752-24-5	Molecular Formula:
Product Number:PCL-#-Di127-100mg	Product Name:1-(2,3-Dichlorophenyl)piperazine dimer hydrochloride; 1,1'-(Ethane-1,1-diphenyl(2,3-dichloro-4,1-phenylene))bis-piperazine dihydrochloride; Piperazine dimer impurity	CAS No.:519138-48-8	Molecular Formula:
Product Number:PCL-#-Fm003-50mg	Product Name:N-Fmoc-N''-trityl-D-asparagine	CAS No.:180570-71-2	Molecular Formula:
Product Number:PCL-#-Pr001-100mg	Product Name:Pramipexole EP impurity C (6S,6'S)-N6,N6'-(2-methylpentane-1,3-diyl)bis(4,5,6,7-tetrahydrobenzothiazole)-2,6-diamine	CAS No.:1973461-14-1	Molecular Formula:
Product Number:PCL-#-Az538-50mg	Product Name:Azithromycin EP impurity Q((3'-N-{[4- (acetyl) phenyl] sulfonyl }- 3'-(N,N- demethyl) azithromycin)	CAS No.:2095879-65-3	Molecular Formula:
Product Number:PCL-#-Fm106-50mg	Product Name:N-(9-fluorenylmethoxycarbonyl)-N'-trityl-L-histidine	CAS No.:109425-51-6	Molecular Formula:
Product Number:PCL-#-Az006-100mg	Product Name:N'-(1-methyl-1-yloxy-azepin-4-yl)-hydrazide benzoate (Azelastine Hydrochloride Impurity M2-I6 Control)	CAS No.:N/A	Molecular Formula:
Product Number:PCL-#-EA357-25mg	Product Name:ethylenediamine-N,N'-diacetic acid	CAS No.:5657-17-0	Molecular Formula:
Product Number:PCL-#-Az015-100mg	Product Name:N'-(1-Methylazepan-4-yl)phenylhydrazine hydrochloride (Azelastine hydrochloride EP impurity B)	CAS No.:117078-69-0	Molecular Formula:
Product Number:PCL-#Me001-25mg	Product Name:Methyl caproate.	CAS No.:106-70-7	Molecular Formula:
Product Number:PCL-#-Ma073-100mg	Product Name:D-malic acid	CAS No.:636-61-3	Molecular Formula:
Product Number:PCL-#-Fm021-200mg	Product Name:Fmoc-Glu(OtBu)-OH	CAS No.:71989-18-9	Molecular Formula:
Product Number:PCL-#-On021-100mg	Product Name:Ondansetron hydrochloride impurity B	CAS No.:1076198-52-1	Molecular Formula:
Product Number:PCL-#-Li278-100mg	Product Name:Rifilgrastim IM03-3	CAS No.:N/A	Molecular Formula:
Product Number:PCL-#-Li277-100mg	Product Name:Rifepristal impurity T	CAS No.:851785-70-1	Molecular Formula:
Product Number:PCL-#-Li321-50mg	Product Name:Linezolid impurity R; N-Methoxycarbonyl-3-fluoro-4(4-morpholinyl)aniline	CAS No.:212325-40-1	Molecular Formula:
Product Number:PCL-#-Li0160-50mg	Product Name:N-[(2S)-3-Amino-2-hydroxypropyl]-N-[3-fluoro-4-(4-morpholinyl)phenyl]acetamide hydrochloride; Linezolid impurity D	CAS No.:1391068-25-9	Molecular Formula:
Product Number:PCL-#-Li1090-50mg	Product Name:Linezolid impurity A, hydrochloride	CAS No.:N/A	Molecular Formula:
Product Number:PCL-#-Ro029-100mg	Product Name:Ropivacaine impurity 20	CAS No.:84951-65-5	Molecular Formula: