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Finasteride EP Impurity B

EP impurity reference standard

CAS103335-41-7
Finasteride EP Impurity B chemical structure
Cat. no. C4X-110311 Purity >95% HPLC Form White Powder

Specifications

Product name
Finasteride EP Impurity B
CAS number
103335-41-7
Catalogue number
C4X-110311
Molecular formula
C20H29NO3
Molecular weight
331.45
Purity (HPLC)
>95%
Physical form
White Powder
Storage
2-8 °C
SMILES
C1=C[C@]2(C)[C@@]3([H])CC[C@]4(C)[C@@H](C(OC)=O)CC[C@@]4([H])[C@]3([H])CC[C@@]2([H])NC1=O
Available pack sizes
10 mg / 20 mg / 25 mg / 50 mg / 100 mg
Lead time
In stock
Intended use
Related substances and impurity testing, method development and validation, system suitability, QC release and stability testing.

Fields shown as — are not published for this item. They are left blank rather than filled with an estimate.

Description

Finasteride EP Impurity B (CAS 103335-41-7) is supplied by ImpurityLab as a European Pharmacopoeia impurity standard, identified by letter against the monograph for its parent substance. Catalogue number C4X-110311.

The material is issued against molecular formula C20H29NO3, molecular weight 331.45 g mol−1, physical form described as white powder.

Structural notation: C1=C[C@]2(C)[C@@]3([H])CC[C@]4(C)[C@@H](C(OC)=O)CC[C@@]4([H])[C@]3([H])CC[C@@]2([H])NC1=O

Letter designations are assigned inside a monograph for one named substance. The same molecule can carry a different letter, or a different style of name, in another pharmacopoeia. Map the material from its structure — chemical name, formula and CAS — rather than from the letter alone.

Storage. Store at 2-8 °C. Allow the container to reach room temperature before opening so that moisture does not condense onto the material. Record the date of first opening on the label.

Pack sizes. 10 mg / 20 mg / 25 mg / 50 mg / 100 mg. Non-standard quantities are quoted on request, normally within two working days.

Documentation. Each lot is released with a certificate of analysis that states the assay method, the water content and the form as supplied. The safety data sheet is available with the same lot number. Quote catalogue number C4X-110311 when requesting either document.

Documentation

Certificate of analysis (per lot)COA-C4X-110311Download
Safety data sheet (SDS)SDS-C4X-110311Download

Documents are issued per lot. The COA you receive describes the lot that ships, not a representative sample.

Regulatory reference

EP Impurity B. Confirm the acceptance criterion, the reporting threshold and the edition of the monograph against your own method before use.

References are provided to help you map a standard to a pharmacopoeial method. Confirm the acceptance criteria against your own method before use.

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