Pirfenidone EP Impurity B
EP impurity reference standard
Specifications
- Product name
- Pirfenidone EP Impurity B
- CAS number
- 1003-68-5
- Catalogue number
C4X-222919- Molecular formula
- C6H7NO
- Molecular weight
- 109.13
- Purity (HPLC)
- >95%
- Physical form
- Pale Yellow to Light Yellow Solid
- Storage
- 2-8 °C
- SMILES
C1(=O)NC=C(C)C=C1- Available pack sizes
- 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
Pirfenidone EP Impurity B (CAS 1003-68-5) is supplied by ImpurityLab as a European Pharmacopoeia impurity standard, identified by letter against the monograph for its parent substance. Catalogue number C4X-222919.
The material is issued against molecular formula C6H7NO, molecular weight 109.13 g mol−1, physical form described as pale yellow to light yellow solid.
Structural notation: C1(=O)NC=C(C)C=C1
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. 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-222919 when requesting either document.
Documentation
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.