Levonorgestrel EP Impurity I CAS 21508-50-9
| CAS No. | 21508-50-9 |
| Molecular Formula | C21H28O3 |
| Molecular Weight | 328.45 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Levonorgestrel EP Impurity I.
CATO supplies Levonorgestrel EP Impurity I (CAS 21508-50-9), a pharmacopoeial impurity reference standard (molecular formula C21H28O3, MW 328.45 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to a steroid core, a hydroxyl group, an ether linkage, Levonorgestrel EP Impurity I is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 328.45 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
Physical & Chemical Properties
| Molecular Formula | C21H28O3 |
| Molecular Weight | 328.45 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1963 |
Related Levonorgestrel Standards
- Levonorgestrel Impurity 40 (10R) (CAS CATO-C4X-167740)
- Levonorgestrel Impurity 41 (CAS CATO-C4X-167741)
- Levonorgestrel EP Impurity G (CAS 87585-03-3)
- Levonorgestrel EP Impurity H (CAS 55555-97-0)
- Levonorgestrel EP Impurity I (CAS 20402-62-4)
- Levonorgestrel EP Impurity S (CAS 176254-10-7)
- Levonorgestrel EP Impurity T (CAS 14507-51-8)
- Levonorgestrel EP Impurity T (CAS 799-43-9)
Recommended Standards
- Estrone Impurity 11 (CAS CATO-C4X-210511)
- Tibolone EP Impurity A (CAS CATO-C4X-240312)
- Tibolone EP Impurity A(10-β-Hydroxy 4-Tibolone) (CAS 105186-35-4)
- Clascoterone Impurity 1 (CAS 39833-17-5)
- Cinacalcet Impurity 14 (CAS 1217809-88-5)
- Losartan Potassium EP Impurity M (CAS 212316-88-6（free base）)
- Crizotinib impurity 38 (CAS CATO-C4X-102538)
- 3,5-Dimethylhexan-3-ol (CAS 4209-91-0)
- N'-(4-Fluorobenzo[d]thiazol-2-yl)benzo[d]thiazole-2-carbohydrazide (CAS 851978-81-9)
- 2,5-Di(1H-1,2,4-triazol-1-yl)terephthalic acid (CAS 2163052-04-6)
- 2-(Dimethylamino)benzoic acid hydrochloride (CAS 209533-97-1)
- (R)-6-fluoro-1,9-dimethyl-2,3,4,5-tetrahydro-1H-pyrido[4,3-b]indole (CAS 2408686-84-8)
- 1-(bromomethyl)pyrene 2595-90-6 3-(Bromomethyl)pyrene (CAS 2595-90-6)
- Semaglutide impurity 48 (CAS CATO-C4X-222648)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
- Worldwide shipping with full export documentation (HS code guidance available)
- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com